Evidence-based Cognitive Behavioral Therapy Research Articles

A novel smartphone application to prevent postpartum depression adapted from an evidence-based cognitive behavioral therapy program: Individual end-user interviews to optimize the intervention.

Postpartum depression (PPD) is more common among pregnant patients who have unmet social needs, such as financial stress or food insecurity, compared to those who do not. Mothers and Babies (MB) is a cognitive behavioral therapy (CBT)-based program that prevents up to 50% of de novo PPD when provided in-person to low-income Spanish- and English-speaking pregnant people without depression. MB's reach has been limited by the need for trained personnel to support the program. Transforming MB into a smartphone application (app) may mitigate this key barrier to scaling MB. To utilize qualitative data from target end-users to create and optimize MBapp, a novel app centered on the MB program. Draft wireframes of MBapp were created in English and Spanish with CBT-based modules adapted from MB. These wireframes included several features shown previously to sustain app engagement: 1) push notifications delivered at participant-preferred times; 2) text-, graphic-, and video-based content; and 3) gamification with digital rewards for app engagement. English- or Spanish-speaking individuals with public health insurance who were between 32 weeks' gestation and six months postpartum and owned smartphones were eligible to consent for individual in-depth interviews. Individuals with prior or current depression were excluded. Interviews were recorded, transcribed, and analyzed using deductive and inductive codes to characterize opinions about MBapp and perceptions of challenges and facilitators of use of MBapp or other perinatal or mental health apps. End-user feedback led to major modifications to the wireframes. Each of these changes was categorized according to the Framework for Modification and Adaptation (FRAME), an established method of systematically reporting adaptations and modifications to evidence-based interventions via end-user feedback. Recruitment ceased with content saturation, defined as three successive participants providing only positive feedback on MBapp's wireframe, without further suggestions for improvement. 25 interviews were completed. Participants were racially and ethnically diverse, generally representing our target end-user population, and 48% of interviews were conducted in Spanish. Participants' suggestions to improve MBapp were categorized within the FRAME as adaptations that improved either content or context to optimize reach, retention, engagement, and fit for end users. Specifically, the following features were added to MBapp secondary to end-user feedback: 1) audio narration; 2) "ask a clinician" non-urgent questions; 3) on-demand module summaries accessible upon module completion; and 4) choice to defer assessments and start the next module. Participants also provided insights into features of perinatal or mental health apps they found appealing or unappealing to understand preferences, challenges, and (non)negotiables for MBapp. Adapting MBapp to incorporate end users' perspectives optimized our digital PPD prevention intervention, ideally increasing its appeal to future users. Our team's next steps will confirm that MBapp is a feasible, acceptable intervention among English- and Spanish-speaking perinatal people at risk of PPD.

Harnessing AI in Anxiety Management: A Chatbot-Based Intervention for Personalized Mental Health Support

Anxiety disorders represent one of the most widespread mental health challenges globally, yet access to traditional therapeutic interventions remains constrained, particularly in resource-limited settings. This study evaluated the effectiveness of an AI-powered chatbot, developed using ChatGPT, in managing anxiety symptoms through evidence-based cognitive-behavioral therapy (CBT) techniques. Fifty participants with mild to moderate anxiety symptoms engaged with the chatbot over two observational phases, each lasting seven days. The chatbot delivered personalized interventions, including mindfulness exercises, cognitive restructuring, and breathing techniques, and was accessible 24/7 to provide real-time support during emotional distress. The findings revealed a significant reduction in anxiety symptoms in both phases, with an average improvement of 21.15% in Phase 1 and 20.42% in Phase 2. Enhanced engagement in Phase 2 suggested the potential for sustained usability and familiarity with the chatbot’s functions. While participants reported high satisfaction with the accessibility and personalization of the chatbot, its inability to replicate human empathy underscored the importance of integrating AI tools with human oversight for optimal outcomes. This study highlights the potential of AI-driven interventions as valuable complements to traditional therapy, providing scalable and accessible mental health support, particularly in regions with limited access to professional services.

Cognitive-behavioral treatment for insomnia and mindfulness-based stress reduction in nurses with insomnia: a non-inferiority internet delivered randomized controlled trial.

Insomnia is a highly prevalent sleep disorder frequently comorbid with mental health conditions in nurses. Despite the effectiveness of evidence-based cognitive behavioral therapy for insomnia (CBT-I), there is a critical need for alternative approaches. This study investigated whether internet-delivered mindfulness-based stress reduction (IMBSR) for insomnia could be an alternative to internet-delivered CBT-I (ICBT-I). The hypothesis was that the IMBSR would be noninferior to the ICBT-I in reducing the severity of insomnia among nurses with insomnia. Additionally, it was expected that ICBT-I would produce a greater reduction in the severity of insomnia and depression than IMBSR. Among 240 screened nurses, 134 with insomnia were randomly allocated (IMBSR, n =67; ICBT-I, n = 67). The assessment protocol comprised clinical interviews and self-reported outcome measures, including the Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), the 15-item Five Facet Mindfulness Questionnaire (FFMQ), and the Client Satisfaction Questionnaire (CSQ-I). The retention rate was 55% with 77.6% (n=104) of participants completing the study. At post-intervention, the noninferiority analysis of the ISI score showed that the upper limit of the 95% confidence interval was 4.88 (P=0.46), surpassing the pre-specified noninferiority margin of 4 points. Analysis of covariance revealed that the ICBT-I group had significantly lower ISI (Cohen's d = 1.37) and PHQ-9 (Cohen's d = 0.71) scores than did the IMBSR group. In contrast, the IMBSR group showed a statistically significant increase in the FFMQ-15 score (Cohen's d = 0.67). Within-group differences showed that both the IMBSR and ICBT-I were effective at reducing insomnia severity and depression severity and improving mindfulness. Overall, nurses demonstrated high levels of satisfaction and adherence to both interventions. The IMBSR significantly reduced insomnia severity and depression, but the findings of this study do not provide strong evidence that the IMBSR is at least as effective as the ICBT-I in reducing insomnia symptoms among nurses with insomnia. The ICBT-I was found to be significantly superior to the IMBSR in reducing insomnia severity, making it a recommended treatment option for nurses with insomnia.

Telehealth cognitive-behavioral therapy for cancer-related cognitive impairment: 2024 update of a model for remote clinical trial participation.

TPS12147 Background: Cancer-related cognitive impairment (CRCI) consists of persistent memory symptoms that adversely affects survivor quality of life (QOL). Memory and Attention Adaptation Training (MAAT) is an evidence-based cognitive behavioral therapy (CBT) for CRCI with demonstrated efficacy in telehealth delivery. MAAT consists of 8 weekly (45 minute) video visits. The aims of this study are to confirm MAAT telehealth efficacy in a phase III RCT (MAAT vs Supportive Therapy; ST) across large catchment areas of two comprehensive cancer centers. A secondary aim is to evaluate treatment-induced brain activation as assessed by functional MRI (fMRI). We present remote treatment and data capture methods of this open NCI-sponsored (R01CA244673) randomized clinical trial (NCT 04586530). These methods have high success in participant accrual despite starting the trial in COVID-19 pandemic conditions and can be readily adopted to other clinical trials to enhance rural/underserved enrollment. Methods: We are enrolling 200 adult, stage I-III breast cancer survivors 1-5 years post-chemotherapy with cognitive complaints. Individuals with CNS disease, previous brain injury, dementia or psychiatric disorder are excluded. All study procedures are completed from the participant’s home (except fMRI). Eligibility screening is a structured phone interview followed by detailed informed consent online (Research Electronic Data Capture: REDCap) with phone guidance. Consented participants complete baseline brief phone-based neurocognitive assessment and validated patient-reported outcome measures (PROs) of cognition and quality of life via REDCap. Participants are randomized to MAAT or ST and assigned treating clinicians at respective cancer centers. All 8 visits are completed through secure telehealth platforms, followed by repeat phone/online assessment post-treatment and again at 6 months. Enrollment began 3/2021. As of 12/12/2023 (33.5 months), 116 participants are enrolled (58% of the planned sample), 116 randomized (MAAT 58; ST 58), with 81 completing post-treatment assessments. If all assessments and treatment visits were in person, travel burden per participant is 977 miles/22 hours driven, and $640 (US 2023 Federal rate). Thus, study travel savings to date are $74,240. Participant feedback indicates telehealth makes participation possible, similar to previous MAAT research. The current RCT demonstrates utility, efficiency and cost-savings of telehealth and remote data capture technology in the conduct of cancer control research. Methods described here can also be adopted for cancer therapeutic trials. Comprehensive cancer centers, where most clinical trials are based, can enhance participation of remote and/or underserved populations that have higher rates of cancer, more disease burden and less opportunity for trial participation. Clinical trial information: NCT04586530 .

Long-Term Effectiveness of Cognitive Behavioral Therapy in Routine Outpatient Care for Youth with Anxiety Disorders

Introduction: This study examined the long-term effectiveness of cognitive behavioral therapy (CBT) (≥ 2 years after the end of therapy) in the routine care of youth (mean 11.95 years; SD = 3.04 years) with primary anxiety disorder (AD). Methods: Two hundred and ten children with any AD as a primary diagnosis and with any comorbidity were included in the “Kids Beating Anxiety (KibA)” clinical trial and received evidence-based CBT. Diagnoses, severity of diagnoses, and further dimensional outcome variables of symptoms and functioning were assessed before (baseline), after the last treatment session (POST), and at two follow-up (FU) assessments in the child and caregiver report: 6 months (6MONTHS-FU) and >2 years (mean 4.31; SD = 1.07 years) after the last treatment session (long-term FU). Results: At POST, 61.38% showed total remission of all and any ADs. At long-term FU, the remission rate was 63.64%. Compared to baseline, ratings of severity, anxiety, impairment/burden, and life quality improved significantly after CBT in child and caregiver report. All pre-post/FU improvements and global success ratings were stable in child (Pre-Post: Hedges’ g = 3.57; Pre-6MONTHS-FU: Hedges’ g = 3.43; Pre-LT-FU: Hedges’ g = 2.34) and caregiver report (Pre-Post: Hedges’ g = 2.00; Pre-6MONTHS-FU: Hedges’ g = 2.31; Pre-LT-FU: Hedges’ g = 2.31) across all POST- and FU-assessment points. Some outcomes showed further significant improvement, and no deterioration was found over the course of time. Effect sizes calculated in the present study correspond to, or even exceed, effect sizes reported in previous meta-analysis. Conclusions: Stable long-term effects of “KibA” CBT for youth with ADs, comparable to those results from efficacy studies, were achieved in a routine practice setting by applying treatment manuals tested in randomized controlled trials. These findings are remarkable, as the patient group studied here consisted of an age group within the main risk phase of developing further mental disorders, and therefore an increase in new-onset anxiety and further mental disorders would be expected over the long time span studied here.

Building Adaptive Coping and Knowledge to Improve Daily Life (Back2Life): A Pilot Feasibility Trial for Youth with Chronic Sickle Cell Pain

Introduction: Cognitive-behavioral therapy (CBT) for pain is an effective non-pharmacological treatment for chronic pain management, yet can have limited generalizability, access, and reach for underrepresented populations like youth with sickle cell disease (SCD). We aimed to conduct a single-arm proof-of-concept clinical trial to evaluate the feasibility, acceptability, and preliminary efficacy of Back2Life, an adapted, culturally congruent CBT intervention for youth with chronic SCD pain and their parents. We hypothesized that Back2Life would be feasible and acceptable as demonstrated by high levels of treatment engagement (≥80% attendance of treatment sessions) and satisfaction. We also expected clinically significant reductions in pain and pain interference and improvements in pain coping efficacy from baseline to 3-month follow-up (primary endpoint) and 6-month follow-up (maintenance endpoint). Methods: Youth receiving care at comprehensive SCD clinics at 3 tertiary care locations within a southeast children's hospital were included if they were aged 10-18 years, any SCD genotype, reported chronic pain (i.e., pain on most days per month for at least 3 months), had English fluency, and had stable disease-modifying treatments in the past 3 months. Youth were excluded if they had comorbid medical conditions typically associated with pain but unrelated to SCD, had significant cognitive or developmental limitations that would interfere with study procedures, or received ≥ 3 sessions of outpatient psychological therapy for pain management in the preceding 6 months. Patients completed assessments at baseline, post-treatment, 3-month follow-up, and 6-month follow-up. Primary outcomes included pain characteristics (i.e., intensity, frequency, burden), pain interference, and coping self-efficacy. Secondary outcomes included depressive symptoms, pain catastrophizing, and sleep quality. The Back2Life program included evidence-based CBT treatment manuals that were adapted based on qualitative feedback from patient and parent stakeholders to optimize the cultural congruence and relevance to chronic SCD pain. Back2Life was an adaptive treatment comprised of 6-10 module-based sessions delivered by a behavioral health coach via telehealth. All participants received 6 core sessions and up to 4 additional sessions were included to optimize tailored treatment components to address individual family needs. Tailored sessions targeted common co-morbidities associated with chronic pain and were identified based on findings of the baseline assessment. Families also could opt-in to tailored sessions based on interest. Descriptive statistics were conducted to evaluate feasibility and acceptability metrics as well as clinically significant changes in primary and secondary clinical outcomes. Results: Youth (n=20) were on average 15.9 years old (SD=1.6), 50% female, 100% Black or African American, and 95% Non-Hispanic/Latinx. Most (80%) had hemoglobin types HbSS or HbSβ 0. Feasibility and acceptability ratings were high, including 85% consent rate, 80% initiated study procedures, 100% treatment session completion, 93% intervention fidelity, 100% reported moderate-high treatment satisfaction, and strong qualitative feedback suggested treatment acceptance. Patients reported clinically significant changes from baseline to 6-month follow-up in pain frequency (>35% reduction), worst and typical pain intensities (>30% reduction), SCD pain burden (>30% reduction), pain interference (moderate to mild severity), and improvement in pain coping self-efficacy (see Table 1). Patients also reported changes in pain catastrophizing (high to moderate severity), depressive symptoms (mild severity to within normal limits), and no change in sleep quality. Conclusions: The Back2Life treatment program demonstrated high feasibility and acceptability, participant engagement, participant retention, and meaningful changes in patient-reported outcomes. An adapted, culturally congruent, telehealth-delivered CBT for pain intervention tailored to meet the unique needs experienced by youth with chronic SCD pain can promote increased access, reach, and health equity in SCD.

The Appa Health App for Youth Mental Health: Development and Usability Study.

Demand for adolescent mental health services has surged in the aftermath of the COVID-19 pandemic, and traditional models of care entailing in-person services with licensed mental health providers are inadequate to meet demand. However, research has shown that with proper training and supervision mentors can work with youth with mental health challenges like depression and anxiety and can even support the use of evidence-based strategies like cognitive behavioral therapy (CBT). In our increasingly connected world, youth mentors can meet with young people on a web-based platform at their convenience, reducing barriers to care. Moreover, the internet has made evidence-based CBT skills for addressing depression and anxiety more accessible than ever. As such, when trained and supervised by licensed clinicians, mentors are an untapped resource to support youth with mental health challenges. The objective of this study was to develop and assess the feasibility and acceptability of Appa Health (Appa), an evidence-based mental health mentoring program for youth experiencing symptoms of depression and anxiety. This paper describes the development, pilot testing process, and preliminary quantitative and qualitative outcomes of Appa's 12-week smartphone app program which combines web-based near-peer mentorship with short-form TikTok-style videos teaching CBT skills created by licensed mental health professionals who are also social media influencers. The development and testing processes were executed through collaboration with key stakeholders, including young people and clinical and research advisory boards. In the pilot study, young people were assessed for symptoms of depression or anxiety using standard self-report clinical measures: the Patient Health Questionnaire-8 and the Generalized Anxiety Disorder-7 scales. Teenagers endorsing symptoms of depression or anxiety (n=14) were paired with a mentor (n=10) based on preferred characteristics such as gender, race or ethnicity, and lesbian, gay, bisexual, transgender, queer (LGBTQ) status. Quantitative survey data about the teenagers' characteristics, mental health, and feasibility and acceptability were combined with qualitative data assessing youth perspectives on the program, their mentors, and the CBT content. Participants reported finding Appa helpful, with 100% (n=14) of teenagers expressing that they felt better after the 12-week program. Over 85% (n=12) said they would strongly recommend the program to a friend. The teenagers were engaged, video chatting with mentors consistently over the 12 weeks. Metrics of anxiety and depressive symptoms reduced consistently from week 1 to week 12, supporting qualitative data suggesting that mentoring combined with CBT strategies has the potential to positively impact youth mental health and warrants further study. Appa Health is a novel smartphone app aiming to improve the well-being of youth and reduce anxiety and depressive symptoms through web-based mentoring and engaging CBT video content. This formative research sets the stage for a large-scale randomized controlled trial recently funded by the National Institutes of Health Small Business Innovation Research program.

Protocol for a randomised controlled trial evaluating the effect of a CBT-I smartphone application (Sleep Ninja®) on insomnia symptoms in children

BackgroundSleep is necessary for healthy development and mental wellbeing. Despite this, many children do not get the recommended duration of sleep each night, and many experience sleep problems. Although treatable, existing interventions for sleep disturbance are time-consuming, burdensome for families, and focus on providing behavioural strategies to parents rather than upskilling children directly. To address this gap, we modified Sleep Ninja®, an evidence-based cognitive behavioural therapy for insomnia (CBT-I) smartphone app for adolescent sleep disturbance, to be appropriate for 10 to 12 year olds. Here, we describe the protocol for a randomised controlled trial to evaluate the effect of Sleep Ninja on insomnia and other outcomes, including depression, anxiety, sleep quality, and daytime sleepiness, and explore effects on the emergence of Major Depressive Disorder (MDD), compared to an active control group.MethodsWe aim to recruit 214 children aged 10 to 12 years old experiencing disturbed sleep. Participants will be screened for inclusion, complete the baseline assessment, and then be randomly allocated to receive Sleep Ninja, or digital psychoeducation flyers (active control) for 6-weeks. The primary outcome, insomnia symptoms, along with depression, anxiety, sleep quality, and daytime sleepiness will be assessed at 6-weeks (primary endpoint), 3-months, and 9-months post-baseline (secondary and tertiary endpoints, respectively). A mixed model repeated measures analytic approach will be used to conduct intention-to-treat analyses to determine whether reductions in insomnia and secondary outcomes are greater for those receiving Sleep Ninja relative to the control condition at the primary and secondary endpoints. The difference in relative risk for MDD onset will be explored at 9-months and compared between conditions.DiscussionThis is the first clinical trial examining the effects of a CBT-I smartphone app in children experiencing sleep disturbance. Results will provide empirical evidence about the effects of Sleep Ninja on insomnia and other mental health outcomes.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12623000587606).Universal Trial NumberU1111-1294-4167.

Self-help application for obsessive-compulsive disorder based on exposure and response prevention technique with prototype design and usability evaluation: Across-sectional study.

Obsessive-compulsive disorder (OCD) is a relatively common disorder that, due to its debilitating nature, significantly affects personal abilities, job performance, social adjustment, and interpersonal relationships. There are significant barriers to accessing evidence-based cognitive-behavioral therapy as a first-line treatment for obsessive-compulsive disorder. Mobile health applications (Apps) offer a promising way to improve access to evidence-based therapies while overcoming these barriers. The present study was to design and evaluate a prototype of a self-help application for people with OCD (the most common pattern of OCD) based on the exposure and response prevention (ERP) technique. This work was developed in four different phases. (1) Needs assessment: a thorough literature review, reviewing existing related programs and apps, and interviewing patients and psychiatrists; (2) Creating a paper prototype: considering the functional features identified in the previous phase using wireframe sketcher software. (3) Creating a digital prototype: developing an actual prototype using Axure RP software based on the information obtained from an expert panel's evaluation of the paper prototype. (4) Prototype usability evaluation: through a heuristic evaluation with experts and usability testing with patients using the SUS questionnaire. After requirement analysis, requirements were defined in the areas of information and educational elements, and functional capabilities. Prototypes designed based on identified requirements include capabilities such as in-app online self-help groups, assessing the severity of the symptoms of the disorder, psychological training, supportive treatment strategies, setting personalized treatment plans, tracking treatment progress through weekly reports provided, anxiety assessment, and setting reminders. The results of the heuristic evaluation with experts made it possible to identify how to provide information and implement the capabilities in a way that is more appropriate and easier for the user.

(017) Use of Knowledge Translation Methodology to Incorporate Research Results into Clinical Practice: Bringing Mindfulness and Cognitive Behavioural Therapy into a local prostate cancer program

Abstract Introduction There is an unmet need for psychological therapies that address sex-related distress in couples after prostate cancer (PCa) beyond pharmaceuticals and device aids. We recently completed a clinical trial that found both mindfulness and cognitive behavioural therapy (CBT) improved couples’ sexual health after prostate cancer (PCa). Given the benefits of these therapies to patients yet the poor translation of research into routine clinical care, we sought to use evidence-informed methods of knowledge translation to make this transition. Objective This was a knowledge translation (KT) and implementation science project. We aimed to share information about the efficacy of these therapies to PCa patients and their partners in a local prostate cancer program by creating and implementing KT tools in a format that was accessible, affirming, and effective. Methods We utilized two KT frameworks: the Knowledge to Action (KTA) cycle and the Consolidated Framework for Implementation Research (CFIR), and collaborated with knowledge partners (prostate cancer program clinical leader partnerships, patient partner consultations, and a focus group of the program staff analyzed using the CFIR framework) to guide implementation. Results We used the first four stages of the KTA cycle, informed by our knowledge partners, to create our KT tools. The first stage involved clarifying the knowledge gap. We then included the evidence-based mindfulness and CBT approaches to various existing time points of patient education in the local program's context. Next, we conducted our focus group to identify potential barriers and facilitators to implementation, and modified our implementation plan accordingly. We created an information card that explained CBT and mindfulness using terminology appropriate for the patient population. The card contained a link to a patient education video we created that instructed patients on how to practice these skills at home. This link was hosted on a webpage with external CBT and mindfulness resource links. Implementation is currently underway. Eligible patients receive the information card at clinical appointments with a registered sexual health nurse and access the education video, which then guides them on how to practice these therapies at home. A questionnaire has been developed to evaluate patient use of these tools, ease of use of the tools, and whether the tools were helpful with respect to improving sexual intimacy and mental health. Data collection is in progress. Conclusions By creating three KT tools to implement mindfulness and CBT patient education materials, we incorporated research findings into routine clinic flow of a local prostate cancer program. These tools have large implications for the current patient population: we filled a gap of a lack of psychosocial education for sexual intimacy for couples after prostate cancer to practice. To the best of our knowledge, this is the first study to use KTA methodology to apply results from a clinical trial directly into clinical practice. This methodology should be incorporated into research funding mechanisms in order to encourage more widespread adoption of bringing research findings into practice. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast, Sustained Therapeutics, AstraZeneca, Astellas, Genetech, Lantheus Merck, Sharp & Dohme, Myovant, Menarini, Tolmar, Vaccitech, Verity

Feasibility and impact of a mental health chatbot on postpartum mental health: a randomized controlled trial

Perinatal mood disorders are common yet underdiagnosed and un- or undertreated. Barriers exist to accessing perinatal mental health services, including limited availability, time, and cost. Automated conversational agents (chatbots) can deliver evidence-based cognitive behavioral therapy content through text message-based conversations and reduce depression and anxiety symptoms in select populations. Such digital mental health technologies are poised to overcome barriers to mental health care access but need to be evaluated for efficacy, as well as for preliminary feasibility and acceptability among perinatal populations. To evaluate the acceptability and preliminary efficacy of a mental health chatbot for mood management in a general postpartum population. An unblinded randomized controlled trial was conducted at a tertiary academic center. English-speaking postpartum women aged 18 years or above with a live birth and access to a smartphone were eligible for enrollment prior to discharge from delivery hospitalization. Baseline surveys were administered to all participants prior to randomization to a mental health chatbot intervention or to usual care only. The intervention group downloaded the mental health chatbot smartphone application with perinatal-specific content, in addition to continuing usual care. Usual care consisted of routine postpartum follow up and mental health care as dictated by the patient's obstetric provider. Surveys were administered during delivery hospitalization (baseline) and at 2-, 4-, and 6-weeks postpartum to assess depression and anxiety symptoms. The primary outcome was a change in depression symptoms at 6-weeks as measured using two depression screening tools: Patient Health Questionnaire-9 and Edinburgh Postnatal Depression Scale. Secondary outcomes included anxiety symptoms measured using Generalized Anxiety Disorder-7, and satisfaction and acceptability using validated scales. Based on a prior study, we estimated a sample size of 130 would have sufficient (80%) power to detect a moderate effect size (d=.4) in between group difference on the Patient Health Questionnaire-9. A total of 192 women were randomized equally 1:1 to the chatbot or usual care; of these, 152 women completed the 6-week survey (n=68 chatbot, n=84 usual care) and were included in the final analysis. Mean baseline mental health assessment scores were below positive screening thresholds. At 6-weeks, there was a greater decrease in Patient Health Questionnaire-9 scores among the chatbot group compared to the usual care group (mean decrease=1.32, standard deviation=3.4 vs mean decrease=0.13, standard deviation=3.01, respectively). 6-week mean Edinburgh Postnatal Depression Scale and Generalized Anxiety Disorder-7 scores did not differ between groups and were similar to baseline. 91% (n=62) of the chatbot users were satisfied or highly satisfied with the chatbot, and 74% (n=50) of the intervention group reported use of the chatbot at least once in 2 weeks prior to the 6-week survey. 80% of study participants reported being comfortable with the use of a mobile smartphone application for mood management. Use of a chatbot was acceptable to women in the early postpartum period. The sample did not screen positive for depression at baseline and thus the potential of the chatbot to reduce depressive symptoms in this population was limited. This study was conducted in a general obstetric population. Future studies of longer duration in high-risk postpartum populations who screen positive for depression are needed to further understand the utility and efficacy of such digital therapeutics for that population.

Brazilian research consortium on obsessive-compulsive spectrum disorders guidelines for the treatment of adult obsessive-compulsive disorder. Part II: Cognitive-Behavior Therapy treatment.

To summarize the evidence-based cognitive-behavioral therapy (CBT) treatment and propose clinical interventions for adult patients with obsessive-compulsive disorder (OCD). A systematic review of the literature on CBT interventions for the treatment of adult OCD, comprising behavior therapy and exposure and response prevention (ERP) was done. The objective of this study is to present updated clinical guidelines to clinicians, providing comprehensive details regarding the necessary procedures to be incorporated into the CBT protocol. We searched the literature published from 2013-2020 in five databases (PubMed, Cochrane, Embase, Psycinfo and Lilacs), considering: study design, primary outcome measures, type of publication and language. Selected articles were assessed for quality with validated tools. Treatment recommendations were classified according to levels of evidence developed by the American College of Cardiology and the American Heart Association (ACC/AHA). We examined 44 new studies used to update the APA guidelines from 2013. High-quality evidence supports CBT including ERP techniques as the first-line CBT treatment for OCD. In addition, protocols for internet-delivered CBT have also demonstrated their efficacy for the treatment of adults with OCD. CBT based on ERP is a widely used treatment according to high-quality scientific evidence to treat adults with OCD.

The Setting-Intervention Fit of Nine Evidence-Based Interventions for Substance Use Disorders Within HIV Service Organizations Across the United States: Results of a National Stakeholder-Engaged Real-Time Delphi Study.

Given substance use disorders (SUDs) among people with HIV are highly prevalent, integrating SUD services within HIV service settings is needed to help end the HIV epidemic. In this study, we assessed the setting-intervention fit (SIF) of 9 evidence-based SUD interventions: acamprosate, disulfiram, oral naltrexone, injectable naltrexone, oral buprenorphine, injectable buprenorphine, contingency management, motivational interviewing, and cognitive behavioral therapy (CBT). Clinical and nonclinical HIV service organizations (HSOs) in the United States. In May 2020, a stakeholder-engaged real-time Delphi was completed with 202 HSOs. HSO respondents rated the extent to which each SUD intervention was fundable, implementable, retainable, sustainable, scalable, and timely for their HSO, and these 6 items were summed into an SIF score (possible range of 0-18). Motivational interviewing had the highest average SIF score (11.42), with SIF scores above the midpoint (9.5) for clinical (11.51) and nonclinical HSOs (11.36). For nonclinical HSOs, none of the other interventions were above the midpoint. For clinical HSOs, the average SIF scores were above the midpoint for CBT (10.97) and oral buprenorphine (9.51). Multivariate regression analyses, which controlled for characteristics of the HSO respondent, revealed geographic region of the United States and whether the HSO currently offered any substance use services as 2 of the best predictors of SIF scores. Notwithstanding the need to improve the SIF for the other evidence-based SUD interventions, motivational interviewing, CBT, and oral buprenorphine are currently the evidence-based SUD interventions with greatest perceived fit for integration within HSOs in the United States.

Telehealth cognitive-behavioral therapy for cancer-related cognitive impairment: A model for remote clinical trial participation.

TPS12143 Background: Cancer-related cognitive impairment (CRCI) can include persistent memory symptoms, and affects many cancer survivors. Memory and Attention Adaptation Training (MAAT) is an evidence-based cognitive behavioral therapy (CBT) that improves CRCI with demonstrated efficacy in telehealth delivery. MAAT consists of 8 weekly (45-minute) video visits. The aims of this study are to confirm MAAT telehealth efficacy in a phase III RCT (MAAT versus Supportive Therapy; ST) across large catchment areas of two comprehensive cancer centers. A secondary aim is to evaluate treatment-induced brain activation as assessed by functional MRI (fMRI) in a subset of participants. We present remote treatment and data capture methods of this open NCI-sponsored (R01CA244673) randomized clinical trial (NCT 04586530). These methods have high success in participant accrual despite COVID-19 pandemic conditions, and can be readily adopted to other clinical trials to enhance rural/underserved enrollment. Methods: We are enrolling 200 adult, stage I-III breast cancer survivors 1-5 years post-chemotherapy with cognitive complaints. Individuals with CNS disease, previous brain injury, dementia or psychiatric disorder are excluded. All study procedures are completed from the participant’s home (except fMRI). Eligibility screening is a semi-structured phone interview followed by detailed informed consent online (Research Electronic Data Capture: REDCap) with staff phone guidance. Consented participants complete baseline brief phone-based neurocognitive assessment and validated patient-reported outcome measures (PROs) of cognition and quality of life via REDCap. Participants are randomized to MAAT or ST and assigned treating clinicians at respective cancer centers. All 8 visits are completed through secure telehealth platforms, followed by repeat phone/online assessment post-treatment and again at 6 months. Enrollment began in 3/2021. As of 1/2022 (9 months), 56 participants are enrolled (28% of the planned sample), 47 randomized (MAAT 24; ST 23), with 24 completing post-treatment assessments. If all assessments and treatment visits were in person, travel burden per participant is 968 miles/20.5 hours driven, and $542 (US 2021 Federal rate). Thus, study travel savings to date are $30,352. Participant feedback indicates telehealth makes participation possible, similar to previous MAAT research. The current RCT demonstrates utility, efficiency and cost-savings of telehealth and remote data capture technology in the conduct of cancer control research. Elements of methods described can also be adopted for cancer therapeutic trials. Comprehensive cancer centers, where most clinical trials are based, can enhance participation of remote and/or underserved populations that have higher rates of cancer, more disease burden and less opportunity for trial participation. Clinical trial information: NCT04586530.

Evaluation of an Augmented Cognitive Behavioural Group Therapy for Perinatal Generalized Anxiety Disorder (GAD) during the COVID-19 Pandemic.

The perinatal period is considered a window of vulnerability given the increased risk of psychiatric difficulties during this time, such as mood and anxiety disorders (ADs). Pre-pandemic rates of ADs in perinatal women were one in five but have since increased with the onset of the COVID-19 pandemic (COVID). In addition, recent research suggests that the focus of worry has shifted during the pandemic, with perinatal women reporting significantly more COVID-specific worries. The objective of this study was to augment our current evidence-based Cognitive Behavioural Group Therapy (CBGT) for perinatal anxiety protocol by targeting intolerance of uncertainty and tailoring existing strategies to address COVID-related worry and impact. Pregnant (n = 19) and postpartum (n = 49) women were recruited from regular clinic patient flow from a university-affiliated teaching hospital between September 2020 and March 2021. Improvements in generalized anxiety symptoms, worry, intolerance of uncertainty, and mood were observed at post-treatment, maintained at 3-months, and the intervention received high ratings of treatment satisfaction. This is the first study to examine an augmented CBGT for perinatal women with GAD during the pandemic and supports the inclusion of strategies that target intolerance of uncertainty as well as specific pandemic and perinatal worry content for effective outcomes.

Adaptive Riding Incorporating Cognitive Behavioral Elements for Youth with Anxiety: Fidelity Outcomes

Abstract Equine-assisted services include novel approaches for treating children’s mental health disorders, one of which is anxiety ( Latella & Abrams, 2019 ). Reining in Anxiety is a manualized approach to adaptive riding drawing on evidence-based cognitive behavioral therapy elements for youth with anxiety. This intervention was delivered by PATH Certified Therapeutic Riding Instructors (CTRIs) in a randomized pilot study. Fidelity checklists, developed to match the core components of the manualized intervention, were collected by independent observers. Fidelity scores addressed an average of 98.7% of components, well beyond the threshold for high fidelity (e.g. >80%) established in the literature ( Garbancz et al., 2014 ). These findings show that the PATH CTRIs trained in the Reining in Anxiety intervention for this study, with supervision and implementation supports, delivered this intervention with high fidelity. This has important implications for expanding access to evidence-based community mental health services beyond traditional clinic settings and providers, and for addressing the gap between the need for and use of evidence-based youth mental health services.

A Social Media Group Cognitive Behavioral Therapy Intervention to Prevent Depression in Perinatal Youth: Stakeholder Interviews and Intervention Design.

BackgroundAdolescents and young adults aged <25 years (youth) are at a higher risk of perinatal depression than older adults, and they experience elevated barriers to in-person care. Digital platforms such as social media offer an accessible avenue to deliver group cognitive behavioral therapy (CBT) to perinatal youth.ObjectiveWe aim to develop the Interactive Maternal Group for Information and Emotional Support (IMAGINE) intervention, a facilitated social media group CBT intervention to prevent perinatal depression in youth in the United States, by adapting the Mothers and Babies (MB) course, an evidence-based in-person group CBT intervention. In this study, we report perspectives of youth and health care providers on perinatal youths’ mental health needs and document how they informed IMAGINE design.MethodsWe conducted 21 semistructured in-depth individual interviews with 10 pregnant or postpartum youths aged 14-24 years and 6 health care workers. All interviews were recorded, transcribed, and analyzed using deductive and inductive approaches to characterize perceptions of challenges and facilitators of youth perinatal mental health. Using a human-centered design approach, stakeholder perspectives were incorporated into the IMAGINE design. We classified MB adaptations to develop IMAGINE according to the Framework for Modification and Adaptation, reporting the nature, timing, reason, and goal of the adaptations.ResultsYouth and health care workers described stigma associated with young pregnancy and parenting, social isolation, and lack of material resources as significant challenges to youth mental wellness. They identified nonjudgmental support, peer companionship, and access to step-by-step guidance as facilitators of youth mental wellness. They endorsed the use of a social media group to prevent perinatal depression and recommended that IMAGINE facilitate peer support, deliver content asynchronously to accommodate varied schedules, use a confidential platform, and facilitate the discussion of topics beyond the MB curriculum, such as navigating support resources or asking medical questions. IMAGINE was adapted from MB to accommodate stakeholder recommendations and facilitate the transition to web-based delivery. Content was tailored to be multimodal (text, images, and video), and the language was shortened and simplified. All content was designed for asynchronous engagement, and redundancy was added to accommodate intermittent access. The structure was loosened to allow the intervention facilitator to respond in real time to topics of interest for youth. A social media platform was selected that allows multiple conversation channels and conceals group member identity. All adaptations sought to preserve the fidelity of the MB core components.ConclusionsOur findings highlight the effect of stigmatization of young pregnancy and social determinants of health on youth perinatal mental health. Stakeholders supported the use of a social media group to create a supportive community and improve access to evidence-based depression prevention. This study demonstrates how a validated intervention can be tailored to this unique group.

Self-guided Cognitive Behavioral Therapy Apps for Depression: Systematic Assessment of Features, Functionality, and Congruence With Evidence.

BackgroundMental health disorders affect 1 in 10 people globally, of whom approximately 300 million are affected by depression. At least half of the people affected by depression remain untreated. Although cognitive behavioral therapy (CBT) is an effective treatment, access to mental health specialists, habitually challenging, has worsened because of the COVID-19 pandemic. Internet-based CBT is an effective and feasible strategy to increase access to treatment for people with depression. Mental health apps may further assist in facilitating self-management for people affected by depression; however, accessing the correct app may be cumbersome given the large number and wide variety of apps offered by public app marketplaces.ObjectiveThis study aims to systematically assess the features, functionality, data security, and congruence with evidence of self-guided CBT-based apps targeting users affected by depression that are available in major app stores.MethodsWe conducted a systematic assessment of self-guided CBT-based apps available in Google Play and the Apple App Store. Apps launched or updated since August 2018 were identified through a systematic search in the 42matters database using CBT-related terms. Apps meeting the inclusion criteria were downloaded and assessed using a Samsung Galaxy J7 Pro (Android 9) and iPhone 7 (iOS 13.3.1). Apps were appraised using a 182-question checklist developed by the research team, assessing their general characteristics, technical aspects and quality assurance, and CBT-related features, including 6 evidence-based CBT techniques (ie, psychoeducation, behavioral activation, cognitive restructuring, problem solving, relaxation, and exposure for comorbid anxiety) as informed by a CBT manual, CBT competence framework, and a literature review of internet-based CBT clinical trial protocols. The results were reported as a narrative review using descriptive statistics.ResultsThe initial search yielded 3006 apps, of which 98 met the inclusion criteria and were systematically assessed. There were 20 well-being apps; 65 mental health apps, targeting two or more common mental health disorders, including depression; and 13 depression apps. A total of 28 apps offered at least four evidence-based CBT techniques, particularly depression apps. Cognitive restructuring was the most common technique, offered by 79% (77/98) of the apps. Only one-third of the apps offered suicide risk management resources, whereas 17% (17/98) of the apps offered COVID-19–related information. Although most apps included a privacy policy, only a third of the apps presented it before account creation. In total, 82% (74/90) of privacy policies stated sharing data with third-party service providers. Half of the app development teams included academic institutions or health care providers.ConclusionsOnly a few self-guided CBT-based apps offer comprehensive CBT programs or suicide risk management resources. Sharing of users’ data is widespread, highlighting shortcomings in health app market governance. To fulfill their potential, self-guided CBT-based apps should follow evidence-based clinical guidelines, be patient centered, and enhance users’ data security.

Cognitive behavioral therapy for depressive disorders: Outcomes from a multi-state, multi-site primary care practice

BackgroundIndividuals with depressive disorders often present to and seek treatment in primary care. Integrated behavioral health services within this setting can improve access to evidence-based cognitive behavioral therapy (CBT). However, limited information exists on the effectiveness of CBT for depression in primary care. MethodsOf the 1,302 participants with a primary depressive disorder referred by their primary care provider, 435 endorsed moderate to severe depression at baseline and engaged in at least one CBT session. A psychotherapy tracking database was used to collect relevant data, which included demographics, clinical characteristics, treatment outcomes, and CBT intervention use. ResultsParticipants with moderate to severe depression who participated in CBT reported a significant decrease in depression and anxiety symptoms at the end of treatment (p ≤ .001, d = 0.52–0.78). Rates of reliable change, response, and remission and types of CBT interventions used differed between major and persistent depressive disorders. LimitationsMultiple limitations must be noted, which are related to the naturalistic study design, inclusion and exclusion criteria, sample operationalization, symptomatic measurement, time-limited and focused assessment, data collection strategies, and psychological services. Together, these temper the conclusions that can be drawn. ConclusionSignificant reductions in depression and anxiety symptoms were reported by participants with depressive disorders who engaged in short-term CBT within primary care. This study indicates that CBT can be implemented within primary care and suggests that primary care patients with depression can benefit from integrated psychological services, supporting population-based models of care.

Specialty knowledge and competency standards for pharmacotherapy for adult obsessive-compulsive disorder

Obsessive-compulsive disorder (OCD) affects approximately one person in 40 and causes substantial suffering. Evidence-based treatments can benefit many; however, optimal treatment can be difficult to access. Diagnosis is frequently delayed, and pharmacological and psychotherapeutic interventions often fail to follow evidence-based guidelines. To ameliorate this distressing situation, the International OCD Accreditation Task Force of the Canadian Institute for Obsessive-Compulsive Disorders has developed knowledge and competency standards for specialized treatments for OCD through the lifespan. These are foundational to evidence-based practice and will form the basis for upcoming ATF development of certification/accreditation programs. Here, we present specialty standards for the pharmacological treatment of adult OCD. We emphasize the importance of integrating pharmacotherapy with clear diagnosis, appreciation of complicating factors, and evidence-based cognitive behavioral therapy. Clear evidence exists to inform first- and second-line pharmacological treatments. In disease refractory to these initial efforts, multiple strategies have been investigated, but the evidence is more equivocal. These standards summarize this limited evidence to give the specialist practitioner a solid basis on which to make difficult decisions in complex cases. It is hoped that further research will lead to development of a clear, multi-step treatment algorithm to support each step in clinical decision-making.