Cognitive Behavioral Therapy Principles Research Articles

Does adjunctive digital CBT for insomnia improve clinical outcomes in an improving access to psychological therapies service?

BackgroundInsomnia has a bidirectional relationship with broader mental health functioning, including anxiety and depression. Yet, poor sleep has historically been neglected as a specific treatment target in mental health programmes (Freeman, Sheaves, Waite, Harvey, & Harrison, 2020). MethodAll patients over a 12-month period entering the Improving Access to Psychological Therapies (IAPT) service endorsing a ‘poor sleep’ questionnaire item at assessment, were offered a self-guided digital sleep intervention, Sleepio, in addition to routine care. Sleepio is based on the principles of Cognitive Behavioural Therapy for Insomnia (CBT-I). Propensity score matching established a non-Sleepio control group matched on demographic and baseline clinical measures. ResultsPatients who signed up to Sleepio (n = 510) achieved significantly better outcomes on core clinical metrics (PHQ-9, GAD-7, WSAS) than controls. IAPT recovery rates11IAPT recovery rate is percentage of those above clinical cutoff on either PHQ-9 or GAD-7 at baseline who no longer meet this criterion at discharge. (on PHQ-9 and GAD-7) were 64.7%, versus 58% in the control group. Duration of clinical contact time was marginally elevated overall in the Sleepio group but by less than 1 h ConclusionsSignificant clinical benefit was associated with the introduction of an evidence-based digital sleep intervention alongside other mental health interventions for depression and anxiety. Widespread deployment was achieved with immediate availability, minimal additional clinical time or staff training. This approach provides a feasible and highly scalable model for improving mental health outcomes in clinical services.

Anxiety and depression in patients who receive anti-VEGF treatment and the usability and feasibility of e-mental health support: the E-PsEYE pilot study.

PurposeE‐PsEYE is an internet‐based, guided self‐help course, following the principles of cognitive behavioural therapy, to reduce anxiety and depression in patients with retinal exudative diseases who receive anti‐vascular endothelial growth factor (anti‐VEGF) treatment. The purpose of this study was to determine the prevalence and related factors of anxiety and depression in this population and evaluate the usability and feasibility of E‐PsEYE.MethodsSymptoms of anxiety and depression and related factors were determined in 90 patients (mean age 77 years, 58% female), based on multiple logistic regression analysis. Five patients with mild to moderate depression/anxiety tested the usability of E‐PsEYE. They were asked to think aloud while completing two modules of the intervention and freely explore system features. The feasibility of the total E‐PsEYE intervention was tested in 14 patients with mild to moderate depression/anxiety, based on a single arm pre‐post study with a follow‐up of three months: fidelity, acceptability, feasibility of study methods and potential effectiveness were explored.ResultsFifty‐three percent of the total study population experienced at least mild anxiety and/or depression symptoms. Especially female patients (odds ratio (OR) 3.89, 95% confidence interval (CI) 1.33–11.40), those who experienced limitations in daily life activities due to vision loss (OR 9.67; 95% CI 3.18–29.45) and those who experienced loneliness (OR 3.53, 95% CI 1.14–10.95) were more likely to have anxiety/depression. The usability study raised several possibilities for improvement, based on which E‐PsEYE was improved. The feasibility study showed adequate fidelity and acceptability. Most participants were satisfied with the results (79%). There was a high response rate, no loss to follow‐up and mental health problems decreased in more than half of the patients. The Wilcoxon signed rank test indicated lower post‐test ranks compared to pre‐test ranks (depression Z −1.34, p = 0.18; anxiety Z −1.45, p = 0.15).ConclusionsMental health problems are prevalent in patients who receive anti‐VEGF treatment. Healthcare providers should recognise these problems and related factors in order to refer patients to appropriate care in a timely manner. Outcomes on the usability and feasibility of E‐PsEYE are promising as a prelude to performing a randomised controlled trial, which will shed more light on its (cost‐)effectiveness.

Text4Support Mobile-Based Programming for Individuals Accessing Addictions and Mental Health Services-Retroactive Program Analysis at Baseline, 12 Weeks, and 6 Months.

Objective: Where traditional approaches fall short, widely accessible and accepted, yet under leveraged, digital technologies such as text messaging present novel opportunities to solve a range of health care solutions. The following provides a preliminary analysis of the Text4Support program, a text-messaging intervention using the principles of cognitive behavioral therapy, which seeks to support the health and well-being of individuals seeking support for addiction or mental health concerns. The goal of this study was to assess whether the Text4Support program improved the perceived overall mental well-being of participants.Methods: The evaluation analyzes survey responses of individuals who were enrolled in the Text4Support program beginning in July 2019, who had completed the 6-months program by May 2020. Participants were asked to provide responses to three surveys during their time in the program—at baseline, 12-weeks and 6-months, which included questions documenting demographic information, general satisfaction with the program, and a participants' level of “global distress” through use of the Clinical Outcomes Routine Evaluation System (CORE-10)—a validated brief 10-item assessment and outcome measurement tool used to assess conditions including anxiety, depression, physical problems, and risk to self.Results and Conclusions: This data set did not include a large enough sample of participants to reach statistical significance. Nevertheless, the study provides some preliminary analysis, and identifies opportunities for the future analysis and research.

Self-help guided by trained lay providers for generalized anxiety disorder in older adults: study protocol for a randomized controlled trial

BackgroundOnly a small proportion of older patients with generalized anxiety disorder (GAD) seek professional help. Difficulties in accessing treatment may contribute to this problem. Guided self-help based on the principles of cognitive-behavioral therapy (GSH-CBT) is one way of promoting access to psychological treatment. Moreover, because the therapist’s role in GSH-CBT is limited to supporting the patient, this role could be assumed by trained and supervised lay providers (LPs) instead of licensed providers. The main goal of this study is to evaluate the efficacy of GSH-CBT guided by LPs for primary threshold or subthreshold GAD in older adults.MethodsWe will conduct a multisite randomized controlled trial comparing an experimental group receiving GSH-CBT guided by LPs (n = 45) to a wait-list control group (n = 45). Treatment will last 15 weeks and will be based on a participant’s manual. Weekly telephone sessions with LPs (30 min maximum) will be limited to providing support. Data will be obtained through clinician evaluations and self-assessment questionnaires. Primary outcomes will be the tendency to worry and severity of GAD symptoms. Secondary outcomes will be anxiety symptoms, sleep difficulties, functional deficit, diagnosis of GAD, and cognitive difficulties. For the experimental group, measurements will take place at pre- and post-treatment and at 6 and 12 months post-treatment. For the control group, three evaluations are planned: two pre-treatment evaluations (before and after the waiting period) and after receiving treatment (post-treatment). The efficacy of GSH-CBT will be established by comparing the change in the two groups on the primary outcomes.DiscussionThis project will provide evidence on the efficacy of a novel approach to treat GAD in older adults. If effective, it could be implemented on a larger scale and provide many older adults with much needed mental health treatment through an expanded workforce.Trial registrationThe trial was registered at ClinicalTrials.gov, number NCT03768544, on December 7, 2018.

Development of a graphic medicine-enabled social media-based intervention for youth social anxiety

ABSTRACT Objective The objective of the Entourage project was to develop an innovative digital mental health intervention addressing key barriers experienced by young people in accessing evidence‐based therapy for social anxiety. In particular, Entourage takes a specific focus on reaching young men, given their lower rates of service engagement. Method This article discusses the theoretical underpinnings, therapeutic mechanisms, persuasive technology elements, and development process of a novel approach incorporating graphic medicine, clinical and peer support, and social networking. Results Based on an integrated cognitive model of social anxiety disorder and consistent with the principles of cognitive behavioural therapy (CBT), a novel digital intervention for social anxiety was developed (Entourage). Using the moderated online social therapy (MOST) model, Entourage provides young people with a digital strengths‐based platform to overcome social anxiety symptoms. Designed in close partnership with young people with a lived experience of mental ill‐health, and overseen by a steering group of young men, Entourage applies graphic medicine through bespoke therapy comics to help users understand and overcome symptoms. Program e‐mentors (expert clinicians and trained peer workers) work in tandem to maintain engagement, support participant skill acquisition, and promote opportunities for social connectedness. Behavioural experiments and in‐vivo exposure activities facilitate restructuring of maladaptive social anxiety‐focussed cognitions. Conclusions Entourage represents an innovative approach to managing social anxiety in young people. Intervention elements seek to ensure longer‐term engagement of users, in particular young men, who have unmet service needs. Results of a single‐group clinical trial of Entourage are forthcoming.

Adapting cognitive-behavioral therapy for a Malaysian muslim.

Background: Over the years, cognitive-behavioural therapy (CBT) has gained momentum because of its robust evidence in the treatment of several disorders. However, there is an issue of religious and cultural appropriateness as CBT principles are based on Western conceptualization. This single‐case study (N = 1) implements a culturally and religiously adapted CBT on a 34‐year‐old male with panic disorder with agoraphobia in Malaysia. The client had symptoms comprising various episodes of sudden onset of breathlessness, accelerated heart rate, and fear of dying for the last 14 years. The CBT was culturally and religiously adapted based on (1) A CBT manual in Bahasa Malaysia that was previously modified and adjusted according to the norms of the Malaysian society and (2) General guidelines in "Religious–Cultural Psychotherapy in the Management of Anxiety Patients" by Razali et al in 2002. The present modified CBT had 3 assessments formulation sessions and 12 intervention sessions. Methods: The first 6 sessions were based on the behaviour component of CBT (ie, a relaxation technique using Islamic prayer, reciting verses from the Holy Quran, slow breathing exercise, body scan, and progressive muscular relaxation). However, sessions 7 to 12 were focused on cognitive restructuring and exercises, such as identification of negative automatic thoughts, cognitive distortions, dysfunctional thought records, vertical arrow technique, and the coping statement was practised through collaborative empiricism, while implementing Islamic and cultural elements. The focus of termination sessions was on interoceptive exposure, cognitive rehearsal, and in vivo situational exposure. Results: Beck Anxiety Inventory (BAI) was administered at regular intervals. BAI scores revealed the effectiveness of adapting the intervention. Conclusion: Panic attacks, worry about panic attacks, and anxiety scores reduced remarkably and the client was able to go out of the house, travel independently, and pursue religious/social activities.

Long-term effects of telephone-based cognitive-behavioral intervention for family caregivers of people with dementia: Findings at 3-year follow-up.

Long-term outcomes are of particular importance in evaluating interventions for family caregivers of people with dementia (PwD). So far, evidence for long-term effects (>6 months postintervention) is limited to four interventions. We examined the long-term effects of Tele.TAnDem, a telephone-based cognitive-behavioral therapy (CBT) intervention, on a variety of outcomes at 3-year follow-up, the longest follow-up of any intervention study for caregivers of PwD (without continuous support). Caregivers of PwD were randomly assigned to receive Tele.TAnDem consisting of 12 sessions over 6 months (intervention group [IG]) or usual care (control group [CG]). At 3-year follow-up (i.e., 2.5 years postintervention), 29 caregivers in the IG and 22 caregivers in the CG were still caring at home for a PwD. Caregivers in the IG reported significantly lower caregiver burden and higher quality of life regarding social relationships. Tele.TAnDem is successful in buffering detrimental effects of caregiving on caregiver burden and social relationships in the long term. The small- to medium-sized effects lie in the range of effect sizes reported in the few previous investigations. The findings add to the scant evidence that interventions yielding long-term outcomes have to date mostly been multicomponent interventions based on CBT principles with structured techniques and at least seven sessions over more than 2 months. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Judging the Book by Its Cover: What Comprises a Cognitive Behavioral Intervention Program for Perpetrators of Intimate Partner Violence?

Substantial literature has examined the effectiveness of intimate partner violence (IPV) interventions, and cognitive behavioral therapy (CBT) is noted as the second most common approach used in group interventions for partner violent men. However, as little research has examined how CBT principles are operationalized across program curricula, there is currently insufficient information from which to make recommendations for model CBT approaches in IPV interventions. In the current study, we review the literature to determine a set of core elements for comprehensive CBT interventions and use session-level curriculum data from 10 community-based programs to examine the presence of 14 components reflecting 4 CBT factors. Results suggest heterogeneity in the emphasis on CBT elements across programs, despite almost all managers listing CBT as a theoretical approach. Implications are discussed with a call for evaluators and meta-analysts to code for actual curriculum content as opposed to stated program labels.

Efficacy of a Six-Week-Long Therapist-Guided Online Therapy Versus Self-help Internet-Based Therapy for COVID-19-Induced Anxiety and Depression: Open-label, Pragmatic, Randomized Controlled Trial.

BackgroundThe COVID-19 pandemic has led to a notable increase in psychological distress, globally. Oman is no exception to this, with several studies indicating high levels of anxiety and depression among the Omani public. There is a need for adaptive and effective interventions that aim to improve the elevated levels of psychological distress due to the COVID-19 pandemic.ObjectiveThis study aimed to comparatively assess the efficacy of therapist-guided online therapy with that of self-help, internet-based therapy focusing on COVID-19–induced symptoms of anxiety and depression among individuals living in Oman during the COVID-19 pandemic.MethodsThis was a 6-week-long pragmatic randomized controlled trial involving 60 participants who were recruited from a study sample surveyed for symptoms of anxiety or depression among the Omani public amid the COVID-19 pandemic. Participants in the intervention group were allocated to receive 1 online session per week for 6 weeks from certified psychotherapists in Oman; these sessions were conducted in Arabic or English. The psychotherapists utilized cognitive behavioral therapy and acceptance and commitment therapy interventions. Participants in the control group received an automatic weekly newsletter via email containing self-help information and tips to cope with distress associated with COVID-19. The information mainly consisted of behavioral tips revolving around the principles of cognitive behavioral therapy and acceptance and commitment therapy. The primary outcome was measured by comparing the change in the mean scores of Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) scale from the baseline to the end of the study (ie, after 6 sessions) between the two groups. The secondary outcome was to compare the proportions of participants with depression and anxiety between the two groups.ResultsData from 46 participants were analyzed (intervention group n=22, control group n=24). There was no statistical difference in the baseline characteristics between both groups. Analysis of covariance indicated a significant reduction in the GAD-7 scores (F1,43=7.307; P=.01) between the two groups after adjusting for baseline scores. GAD-7 scores of participants in the intervention group were considerably more reduced than those of participants in the control group (β=−3.27; P=.01). Moreover, a greater reduction in mean PHQ-9 scores was observed among participants in the intervention group (F1,43=8.298; P=.006) than those in the control group (β=−4.311; P=.006). Although the levels of anxiety and depression reduced in both study groups, the reduction was higher in the intervention group (P=.049) than in the control group (P=.02).ConclusionsThis study provides preliminary evidence to support the efficacy of online therapy for improving the symptoms of anxiety and depression during the COVID-19 crisis in Oman. Therapist-guided online therapy was found to be superior to self-help, internet-based therapy; however, both therapies could be considered as viable options.Trial RegistrationClinicalTrials.gov NCT04378257; https://clinicaltrials.gov/ct2/show/NCT04378257

Mindfulness-based cognitive therapy in functional dyspepsia: A pilot randomized trial.

Patients with functional dyspepsia (FD) often have concomitant anxiety and depression. Mindfulness-based cognitive therapy (MBCT) combines the principles of cognitive behavioral therapy and mindfulness. It is a group-based therapy and has been shown to be efficacious in functional gastrointestinal disorders. There are no randomized controlled trials (RCTs) evaluating MBCT in FD. We aimed to evaluate feasibility and efficacy of MBCT in FD management. We performed a mixed-method single-center pilot randomized trial of 28 patients fulfilling ROME-III criteria for FD. Fifteen patients were randomized to an 8-week MBCT program while 13 underwent treatment-as-usual (TAU). Patients completed questionnaires at baseline and at week 8. Two focus-groups were conducted. Feasibility of recruitment, acceptability of randomization, procedures and intervention, handout compliance and feasibility of quantitative measures were assessed. The primary outcome was subjective-clinical-assessment of FD symptoms (SCA-FD). Secondary outcome measures included Short-form Nepean Dyspepsia Index (SF-NDI), subjective-clinical-assessment of general health (SCA-GH), EuroQoL-Visual Analog Scale (EuroQoL-VAS), and Depression, Anxiety and Stress Scale-21 Items (DASS-21). Twelve of 15 patients in the MBCT group completed the program. There was a trend towards symptom improvement, with 90% in the MBCT group reporting improvement in SCA-FD compared with 45% in TAU(P=0.063). Patients who underwent MBCT reported greater improvement in SF-NDI (mean change: -8.8 (SD: 7.5) vs -0.7 (7.2), P=0.018) and DASS-21 (-19.8 (29.5) vs -5.5 (6.6) P=0.13) compared with TAU. There was no difference in SCA-GH and EuroQoL-VAS. Based on SCA-FD improvement, the eventual RCT will require 50 patients (25 in each group). Mindfulness-based cognitive therapy is likely efficacious for FD, and it would be feasible to conduct a RCT.

A Mindfulness-Based Intervention for Student Depression, Anxiety, and Stress: Randomized Controlled Trial.

BackgroundUniversity students are experiencing higher levels of distress and mental health disorders than before. In addressing mental health needs, web-based interventions have shown increasing promise in overcoming geographic distances and high student-to-counselor ratios, leading to the potential for wider implementation. The Mindfulness Virtual Community (MVC) program, a web-based program, guided by mindfulness and cognitive behavioral therapy principles, is among efforts aimed at effectively and efficiently reducing symptoms of depression, anxiety, and perceived stress in students.ObjectiveThis study’s aim was to evaluate the efficacy of an 8-week MVC program in reducing depression, anxiety, and perceived stress (primary outcomes), and improving mindfulness (secondary outcome) in undergraduate students at a large Canadian university. Guided by two prior randomized controlled trials (RCTs) that each demonstrated efficacy when conducted during regular university operations, this study coincided with a university-wide labor strike. Nonetheless, the students’ response to an online mental health program on a disrupted campus can provide useful information for anticipating the impact of other disruptions, including those related to the COVID-19 pandemic as well as future disruptions.MethodsIn this parallel-arm RCT, 154 students were randomly allocated to an 8-week MVC intervention (n=76) or a wait-list control (WLC) condition (n=78). The MVC intervention included the following: (1) educational and mindfulness video modules, (2) anonymous peer-to-peer discussions, and (3) anonymous, group-based, professionally guided, 20-minute videoconferences. Study outcomes were evaluated at baseline and at 8-week follow-up using the following: Patient Health Questionnaire-9 (PHQ-9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Generalized estimation equations with an AR (1) covariance structure were used to evaluate the impact of the intervention, with outcome evaluations performed on both an intention-to-treat (ITT) and per-protocol (PP) basis.ResultsParticipants (n=154) included 35 males and 117 females with a mean age of 23.1 years. There were no statistically significant differences at baseline between the MVC and WLC groups on demographics and psychological characteristics, indicating similar demographic and psychological characteristics across the two groups. Results under both ITT and PP approaches indicated that there were no statistically significant between-group differences in PHQ-9 (ITT: β=–0.44, P=.64; PP: β=–0.62, P=.053), BAI (ITT: β=–2.06, P=.31; PP: β=–2.32, P=.27), and FFMQ-SF (ITT: β=1.33, P=.43; PP: β=1.44, P=.41) compared to WLC. There was a significant difference for the PSS (ITT: β=–2.31, P=.03; PP: β=–2.38, P=.03).ConclusionsDuring a university labor strike, the MVC program led to statistically significant reductions in PSS compared to the WLC group, but there were no other significant between-group differences. Comparisons with previous cycles of intervention testing, undertaken during nondisrupted university operations, when efficacy was demonstrated, are discussed.Trial RegistrationISRCTN Registry ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275

Application of the Cognitive-Behavior Therapy principles in the development of e-mental health tools

E-mental health tools are a new format of treatment delivery that can increase population’s access to mental health services. Its effectiveness is higher when grounded on evidence-based therapeutic protocols, such as Cognitive-Behavior Therapy (CBT). We aim to understand how CBT principles can be applied in the development of e-mental health tools, more specifically, in web-based interventions. We use the case example of the Be a Mom program, a web-based psychological intervention, grounded on the principles of CBT, designed to prevent postpartum depression and targeting high-risk postpartum women in the Portuguese population. We describe how the design of Be a Mom was grounded in CBT, by addressing: a) general CBT principles; b) its therapeutic mechanisms; and c) organization of sessions. Also, we discuss
 the relevance of the therapeutic alliance in web-based interventions and the importance of evidence-based interventions. By providing insight on how the principles of CBT can be operationalized in an innovative delivery format, we can contribute to the further development of web-based interventions, as well as to increase awareness and knowledge among mental health professionals about the similarities between the principles underlying web-based and face-to-face CBT interventions.

Enhancing the Biopsychosocial Approach to Perioperative Care: A Pilot Randomized Trial of the Perioperative Pain Self-management (PePS) Intervention.

The current study aimed to pilot the PePS intervention, based on principles of cognitive behavioral therapy (CBT), to determine feasibility and preliminary efficacy for preventing chronic pain and long-term opioid use. Surgery can precipitate the development of both chronic pain and long-term opioid use. CBT can reduce distress and improve functioning among patients with chronic pain. Adapting CBT to target acute pain management in the postoperative period may impact longer-term postoperative outcomes. This was a mixed-methods randomized controlled trial in a mixed surgical sample with assignment to standard care or PePS, with primary outcomes at 3-months postsurgery. The sample consisted of rural-dwelling United States Military Veterans. Logistic regression analyses found a significant effect of PePS on odds of moderate-severe pain (on average over the last week) at 3-months postsurgery, controlling for preoperative moderate-severe pain: Adjusted odds ratio = 0.25 (95% CI: 0.07-0.95, P < 0.05). At 3-months postsurgery, 15% (6/39) of standard care participants and 2% (1/45) of PePS participants used opioids in the prior seven days: Adjusted Odds ratio = 0.10 (95% CI: 0.01-1.29, P = .08). Changes in depression, anxiety, and pain catastrophizing were not significantly different between arms. The findings from this study support the feasibility and preliminary efficacy of the PePS intervention.

Feasibility, Acceptability, and Effectiveness of Enhanced Cognitive Behavioral Therapy (eCBT) for Children and Adolescents With Obsessive-Compulsive Disorder: Protocol for an Open Trial and Therapeutic Intervention.

BackgroundAlthough the evidence base of cognitive behavioral therapy (CBT) for pediatric obsessive-compulsive disorder (OCD) has been broadly established, the treatment is hampered by limited access, poor compliance, and nonresponse. New technologies offer the opportunity to improve the accessibility, user friendliness, and effectiveness of traditional office-based CBT. By employing an integrated and age-appropriate technologically enhanced treatment package, we aim to execute a more focused and attractive application of CBT principles to increase the treatment effect for pediatric OCD.ObjectiveThe aim of this open study is to explore the acceptability, feasibility, and effectiveness of a newly developed enhanced CBT (eCBT) package for pediatric OCD.MethodsThis study is an open trial using a historical control design conducted at the outpatient clinic of the Department of Child and Adolescent Psychiatry at St. Olavs University Hospital (Trondheim) or at BUP Klinikk (Aalesund). Participants are 30 children (age 7-17 years) with a primary Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of OCD, and their parents. All participants receive eCBT. eCBT consists of the usual evidence-based CBT for pediatric OCD in an “enhanced” format. Enhancements include videoconferencing sessions (supervision and guided exposure exercises at home) in addition to face-to-face sessions; an app system of interconnected apps for the child, the parents, and the therapist; psychoeducative videos; and frequent online self-assessments with direct feedback to patients and the therapist. Primary outcome measures are the Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) (effectiveness), the Client Satisfaction Questionnaire-8 (acceptability), and treatment drop out (feasibility). Assessments are conducted pretreatment, posttreatment, and at 3- and 6-month follow-ups. A 12-month follow-up assessment is envisioned. The treatment outcome (CY-BOCS) will be compared to traditional face-to-face CBT (data collected in the Nordic Long-term OCD Treatment Study).ResultsEthical approval has been obtained (2016/716/REK nord). Inclusion started on September 04, 2017. Data collection is ongoing.ConclusionsThis study is the first step in testing the acceptability, feasibility, and preliminary effectiveness of eCBT. In case of positive results, future steps include improving the eCBT treatment package based on feedback from service users, examining cost-effectiveness in a randomized controlled trial, and making the package available to clinicians and other service providers treating OCD in children and adolescents.Trial RegistrationISRCTN, ISRCTN37530113; registered on January 31, 2020 (retrospectively registered); https://www.isrctn.com/ISRCTN37530113.International Registered Report Identifier (IRRID)DERR1-10.2196/24057

The Effect of Cognitive-Behavioral Training Versus Conventional Training on Self-care and Depression Severity in Heart Failure Patients with Depression: A Randomized Clinical Trial.

Introduction: Psychological factors including depression and anxiety are the most critical risk factors in the treatment and prognosis of heart failure which should be addressed in treatment and care programs. The purpose of this study was to examine the effect of cognitive-behavioral training (CBT) on depression severity and self-care ability of patients with heart failure.Methods: This study was a randomized clinical trial that carried out on 80 patients with heart failure who had been hospitalized in 2018. The participants were divided into the CBT group (n= 40) and the conventional training (CT) group (n= 40), randomly. Data were collected using Beck Depression Inventory (BDI) and the Self-Care of Heart Failure Index (SCHFI) version 6.2 before and 8 weeks after the educational interventions. Data were analyzed in SPSS 21 using paired t-test, independent t-test, chi-square test, and covariance analysis.Results: The mean score of self-care in the CBT group turned out to be significantly higher than the CT group after receiving the intervention. Also, the mean depression score of the CBT group 26.95 (5.53) after intervention was significantly lower than the CT group 36.04 (8.45).Conclusion: Cognitive-behavioral intervention, compared with conventional training, had a greater positive impact on improving self-care and alleviating the severity of depression symptoms. Therefore, it is recommended that the principles of cognitive-behavioral therapy be integrated into routine educational programs.

Islamic Trauma Healing: Integrating Faith and Empirically Supported Principles in a Community-Based Program

Access to adequate, much less state-of-the-art, mental health care is a global problem. Natural disasters, civil war, and terrorist conflict have forcibly displaced millions of Muslims and have resulted in a remarkable level of individual and communitywide trauma exposure. As a result, many are at risk for posttraumatic stress and other trauma-related disorders. Many religiously oriented Muslims traditionally rely on Islamic principles and teachings, as well as their community, to cope with and address trauma-related distress. Islamic Trauma Healing is a six-session, lay-led group intervention developed within a Somali Muslim community that integrates evidence-based trauma-focused cognitive-behavioral therapy principles with cultural and religious practices aimed to enhance uptake and create an easily up-scalable intervention for a wide range of trauma. In sessions, narratives of prophets who have undergone trauma (e.g., Prophet Ayyub, faith during hard times) present Islamic principles and facilitate cognitive shifts. Group members spend individual time turning to Allah in dua (i.e., informal prayer), focused on exposure to trauma memories. Program themes arc across suffering to healing to growth following trauma. This paper describes the core theoretical principles and methods in the Islamic Trauma Healing program. We also describe leader perspectives and the program’s train-the-trainer model, in which lay leaders are trained to further disseminate the program and allow Islamic Trauma Healing to be owned and sustained by the Muslim community.

Internet-Based Multimodal Pain Program With Telephone Support for Adults With Chronic Temporomandibular Disorder Pain: Randomized Controlled Pilot Trial.

BackgroundChronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities.ObjectiveThe aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial.MethodsAn unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting.ResultsOnly 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up—characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: z=–2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: z=–2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 months: z=–3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001).ConclusionsThis study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible.Trial RegistrationClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762

Assessment of the efficacy of a fatigue management therapy in schizophrenia: study protocol for a randomized, controlled multi-centered study (ENERGY)

BackgroundFatigue is a well-known common clinical feature of numerous chronic diseases including various forms of cancer, neurological disorders such as multiple sclerosis, and psychiatric disorders. A significant proportion of people with schizophrenia (30–60%) reportedly experience fatigue, which impacts negatively on participation in various activities, including work, study, leisure, and social pursuits. Causes of fatigue in schizophrenia are poorly understood and there are no established treatments. Several evidence-based interventions for fatigue syndrome including psychoeducation, cognitive behavioral therapy, and graded exercise therapy have been shown to be effective in other medical conditions and could be adapted to address fatigue in schizophrenia patients. As there are no psychosocial or pharmacological interventions with proved efficacy for fatigue in schizophrenia, there is an urgent need for the development of strategies to improve fatigue management in schizophrenia.The aim of this project is to evaluate in a single blind randomized clinical trial the efficacy of a cognitive-behavioral therapy (CBT) intervention compared to treatment as usual (TAU) on fatigue as the main outcome in schizophrenia patients. Clinical symptoms, physical functioning, major cognitive functions, quality of life and functioning, treatment dosage, daily motor activity, biological markers with inflammatory markers are also considered as secondary outcomes.Methods/designTwo hundred patients meeting the inclusion criteria will be randomized to either of the study arms (intervention or TAU). The ENERGY intervention will be delivered according to a standardized treatment manual comprising six modules addressing fatigue and sleep over 14 individual therapy sessions. The treatment encompasses core CBT principles of psycho-education, behavioral activation, behavioral experiments, cognitive restructuring, problem-solving, and relapse prevention. Sessions will follow the traditional CBT structure of agenda setting, review of homework tasks, and introduction of a new concept/technique with collaborative discussions on how to implement such strategies in the participant’s day-to-day environment. Our primary endpoint will be the severity of fatigue assessed at baseline and at the 9-month follow-up using the “Multidimensional Fatigue Inventory” (MFI).DiscussionThe trial will provide the first test of CBT intervention for fatigue for patients with schizophrenia. This study will also test to what extent the treatment can be implemented in everyday practice.Trial registrationClinicalTrials.govNCT04332601. Registered on 10 April 2020.

Effectiveness of the Super Skills for Life programme in enhancing the emotional wellbeing of children and adolescents in residential care institutions in a low- and middle-income country: A randomised waitlist-controlled trial

BackgroundThe present study examined the effectiveness of a transdiagnostic prevention programme, Super Skills for Life (SSL), among children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius using a randomised waitlist-controlled trial (RCT). SSL is based on the principles of cognitive behavioural therapy, behavioural activation, social skills training, and uses video-feedback and cognitive preparation as part of the treatment. MethodsThe RCT involved 100 children and adolescents aged 9 to 14 years, from six RCIs, randomly allocated to either an SSL intervention group (IG) or a waitlist-control (WLC) group. A set of questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control, were completed at baseline, post-intervention and 3-month follow-up. Participants also completed a 2-min video speech task during the first and final sessions of the SSL intervention. ResultsChildren and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up. These findings were not replicated among children in the WLC. LimitationsThe small sample size and lack of an active control group were the major limitations of this study. ConclusionsThis study provides evidence for the effectiveness of a transdiagnostic prevention programme for emotional problems in RCIs in a low- and middle-income country.

Cognitive behavioural therapy in virtual reality treatments across mental health conditions: a systematic review.

Virtual reality (VR) has been effectively used in the treatment of many mental health disorders.However, significant gaps exist in the literature. There is no treatment framework for researchers to use when developing new VR treatments. One recommended treatment across a range of diagnoses, which may be suitable for use in VR treatments, is Cognitive Behavioural Therapy (CBT). The aim of this systematic review is to investigateCBT treatment methods that utilize VR to treat mental health disorders. To investigate how CBT has been used in VR to treat mental health disorders and to report onthe treatment characteristics (number of sessions, duration, and frequency) that are linked to effective and ineffective trials. Studies were included if patients had a mental health diagnosis and their treatment included immersiveVR technology and CBT principles. Data were extracted in relation to treatment characteristics and outcomes,and analysed using narrative synthesis. Ninety-three studies were analysed. Exposure-based VR treatments were mainly used to treat anxiety related disorders. Treatments generally consisted of eight sessions, once a week for approximately one hour. VR treatments were commonly equal to or more effective than traditional face-to-face methods. No specific treatment characteristics were linked to this effectiveness. The number, frequency and duration of the VR treatment sessions identified in this review, could be used as a treatment framework by researchers and clinicians. This could potentially save researchers time and money when developing new interventions.