Low-intensity Cognitive Behavioural Therapy Research Articles

Cognitive Behavioral Therapy for Chronic Pelvic Pain: What Is It and Does It Work?

Urologic chronic pelvic pain syndrome (UCPPS), which encompasses interstitial cystitis/bladder pain syndrome in women and men and chronic prostatitis/chronic pelvic pain syndrome in men, is a common, often disabling urological disorder that is neither well understood nor satisfactorily treated with medical treatments. The past 25 years have seen the development and validation of a number of behavioral pain treatments, of which cognitive behavioral therapy (CBT) is arguably the most effective. CBT combines strategies of behavior therapy, which teaches patients more effective ways of behaving, and cognitive therapy, which focuses on correcting faulty thinking patterns. As a skills-based treatment, CBT emphasizes "unlearning" maladaptive behaviors and thoughts, and replacing them with more adaptive ones that support symptom self-management. This review describes the rationale, technical procedures, and empirical basis of CBT. While evidence supports CBT for treatment-refractory chronic pain disorders, there is limited understanding of why or how CBT might work, for whom it is most beneficial, or the specific UCPPS symptoms (eg, pain, urinary symptoms) it effectively targets. This is the focus of EPPIC (Easing Pelvic Pain Interventions Clinical Research Program), a landmark NIH trial examining the efficacy of low-intensity, home-based CBT for UCPPS relative to a nonspecific comparator featuring self-care recommendations of AUA guidelines. Systematic efforts to increase both the efficiency of CBT and the way it is delivered (eg, home-based treatments) are critical to scaling up CBT, optimizing its therapeutic potential, and reducing the public health burden of UCPPS.

Use and Engagement With Low-Intensity Cognitive Behavioral Therapy Techniques Used Within an App to Support Worry Management: Content Analysis of Log Data.

Low-intensity cognitive behavioral therapy (LICBT) has been implemented by the Improving Access to Psychological Therapies services across England to manage excessive worry associated with generalized anxiety disorder and support emotional well-being. However, barriers to access limit scalability. A solution has been to incorporate LICBT techniques derived from an evidence-based protocol within the Iona Mind Well-being app for Worry management (IMWW) with support provided through an algorithmically driven conversational agent. This study aims to examine engagement with a mobile phone app to support worry management with specific attention directed toward interaction with specific LICBT techniques and examine the potential to reduce symptoms of anxiety. Log data were examined with respect to a sample of "engaged" users who had completed at least 1 lesson related to the Worry Time and Problem Solving in-app modules that represented the "minimum dose." Paired sample 2-tailed t tests were undertaken to examine the potential for IMWW to reduce worry and anxiety, with multivariate linear regressions examining the extent to which completion of each of the techniques led to reductions in worry and anxiety. There was good engagement with the range of specific LICBT techniques included within IMWW. The vast majority of engaged users were able to interact with the cognitive behavioral therapy model and successfully record types of worry. When working through Problem Solving, the conversational agent was successfully used to support the user with lower levels of engagement. Several users engaged with Worry Time outside of the app. Forgetting to use the app was the most common reason for lack of engagement, with features of the app such as completion of routine outcome measures and weekly reflections having lower levels of engagement. Despite difficulties in the collection of end point data, there was a significant reduction in severity for both anxiety (t53=5.5; P<.001; 95% CI 2.4-5.2) and low mood (t53=2.3; P=.03; 95% CI 0.2-3.3). A statistically significant linear model was also fitted to the Generalized Anxiety Disorder-7 (F2,51=6.73; P<.001), while the model predicting changes in the Patient Health Questionnaire-8 did not reach significance (F2,51=2.33; P=.11). This indicates that the reduction in these measures was affected by in-app engagement with Worry Time and Problem Solving. Engaged users were able to successfully interact with the LICBT-specific techniques informed by an evidence-based protocol although there were lower completion rates of routine outcome measures and weekly reflections. Successful interaction with the specific techniques potentially contributes to promising data, indicating that IMWW may be effective in the management of excessive worry. A relationship between dose and improvement justifies the use of log data to inform future developments. However, attention needs to be directed toward enhancing interaction with wider features of the app given that larger improvements were associated with greater engagement.

A meta-analysis on the efficacy of low-intensity cognitive behavioural therapy for generalised anxiety disorder.

Low-intensity cognitive behavioural therapy (LICBT) has been recommended as a primary intervention in the tiered care for mild to moderate generalised anxiety disorder. However, LICBT for generalised anxiety disorder are markedly diverse and efficacy data on various outcomes have not been systematically reviewed. This meta-analysis aimed to synthesise effect sizes of three NICE-recommended LICBT for generalised anxiety disorder: non-facilitated self-help, guided self-help, and psychoeducational groups. A systematic literature review of randomised controlled trials (RCTs) examining LICBT for generalised anxiety disorder in the last 23years (2000-2023) was conducted. Efficacy data for anxiety, depression, and worry outcomes were separately meta-analysed. The study was reported following the PRISMA guidelines. The systematic review identified 12 RCTs out of 1205 papers. The three meta-analyses consisted of 12 (anxiety), 11 (depression), and 9 (worry) effect sizes respectively, including total sample sizes of 1201 (anxiety), 1164 (depression), and 908 (worry). The adjusted effect sizes for reductions in anxiety (g = -0.63), depression (g = -0.48), and worry (g = -0.64) were all in the medium range, favouring LICBT over control conditions. Between-study heterogeneity was significant on anxiety and worry, with no specific moderators identified by meta-regression. LICBT has shown promise as an effective and efficient treatment modality for individuals with generalised anxiety disorder. Future research comparing various LICBT subtypes and treatment components will further inform clinical practice. This systematic review protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO; record ID CRD42021285590).

Therapeutic Goal Types in Young People’s Mental Health Providers and Changes in Anxiety and Mood

Clinical goal setting is an important area of practice within mental health interventions for children and young people (CYP). The present research aimed to explore the type of intervention goals set by CYP during mental health interventions. Further, changes in goal progress from pre- to post-intervention were compared between externally observed behavioural goals and subjective feelings-based goals. The relationship between therapeutic goal achievement and changes in symptoms of depression and anxiety (measured using the Revised Children’s Anxiety and Depression Scale) was also investigated. Data were collected from 792 participants aged 3 to 18 years (mean age: 13.8, SD: 2.85) across all gender identities and ethnicities, who received low-intensity cognitive behavioural therapy interventions from Children’s Wellbeing Practitioners in the Southwest of England. A mixed methods approach involving conceptual content analysis, correlational analysis, and group comparisons was utilised. Eleven categories of child-rated goals were identified. The most commonly developed goals focused on understanding, managing, and expressing emotions and feelings. No significant differences were found between behavioural and feelings-based goals (p = 0.061). Partial correlations demonstrated that improvements in goal progress were significantly associated with reductions in depression and anxiety symptoms (rs > −0.157, p < 0.001), even when controlling for the number of sessions attended (rs > −0.146, p < 0.001). Integrating goal-based outcomes with standardised measures could enhance a comprehensive approach to service delivery and evaluation.

Feasibility and Acceptability of the Aboriginal and Islander Mental Health Initiative for Youth App: Nonrandomized Pilot With First Nations Young People.

Despite young First Nations Australians being typically healthy, happy, and connected to family and culture, high rates of emotional distress, suicide, and self-harm are also observed. Differing worldviews of service providers and First Nations young people regarding illness and treatment practices, language differences, culturally inappropriate service models, geographical remoteness, and stigma can all inhibit access to appropriate mental health support. Mental health treatments delivered digitally (digital mental health; dMH) offer flexible access to evidence-based, nonstigmatizing, low-cost treatment and early intervention on a broad scale. There is a rapidly growing use and acceptance of these technologies among young First Nations people. The objective was to assess the feasibility, acceptability, and use of the newly developed Aboriginal and Islander Mental Health Initiative for Youth (AIMhi-Y) app and determine the feasibility of study procedures in preparation for future assessments of effectiveness. This was a nonrandomized pre-post study using mixed methods. First Nations young people aged 12-25 years who provided consent (with parental consent where appropriate) and possessed the ability to navigate a simple app with basic English literacy were included. Researchers conducted one face-to-face 20-minute session with participants to introduce and orient them to the AIMhi-Y app. The app integrates culturally adapted low-intensity cognitive behavioral therapy (CBT), psychoeducation, and mindfulness-based activities. Participants received supportive text messages weekly throughout the 4-week intervention period and completed assessments of psychological distress, depression, anxiety, substance misuse, help-seeking, service use, and parent-rated strengths and difficulties at baseline and 4 weeks. Qualitative interviews and rating scales were completed at 4 weeks to gain feedback on subjective experience, look and style, content, overall rating, check-ins, and involvement in the study. App use data were collected. Thirty young people (17 males and 13 females) aged between 12 and 18 (mean 14.0, SD 1.55) years were assessed at baseline and 4 weeks. Repeated measures 2-tailed t tests showed improvements in well-being measures that were statistically and clinically significant for psychological distress (Kessler Psychological Distress Scale, 10-item) and depressive symptoms (Patient Health Questionnaire, 2-item). Participants spent on average 37 minutes in the app. The app was rated positively, with mean ratings of 4 out of 5 points (on scales of 1-5). Participants reported that they found the app easy to use, culturally relevant, and useful. The feasibility of the study was demonstrated with a 62% recruitment rate, a 90% retention rate, and high study acceptability ratings. This study supports earlier research suggesting that dMH apps that are appropriately designed with and for the target populations are a feasible and acceptable means of lowering symptoms for mental health disorders among First Nations youth.

A pilot evaluation of the role of a children's wellbeing practitioner (CWP) in a child and adolescent mental health service (CAMHS).

In 2017, the Children and Young People's Improving Access to Psychological Therapies (CYP-IAPT) project was extended to deliver low-intensity Cognitive Behavioural Therapy (CBT), delivered by Children's Wellbeing Practitioners (CWPs), but to date evaluation is sparse. To evaluate low-intensity interventions delivered by trainee CWPs for the treatment of anxiety and depression in a child and adolescent mental health service (CAMHS). The evaluation adopted a quantitative, within-subjects, cross-sectional design. The outcome measures of 98 service users aged 8-17years were included in the evaluation. Service users were children and young people accessing CAMHS in the North East of England. Outcome measures included the Revised Children's Anxiety and Depression Scale (RCADS-47) and Goal Based Outcomes (GBOs). Descriptive data relating to the types of interventions used and outcomes following CWP involvement were also explored. Analysis of pre and post intervention data highlighted significant reduction in symptomatology across all RCADS subscales and composite total scales, and significant goal progress as measures by GBO's. Effect sizes ranged from moderate to large (d = 0.75 - 0.90) across all subscales of the RCADS. Large effect sizes were found for depression, total anxiety and total RCADS scores (d = 0.86, d = 1.12, d = 1.14), and GBOs (d = -1.33). Findings support the potential value of low intensity CBT interventions delivered by CWPs in reducing anxiety and depression in this population. Recommendations for the development of the CWP role and CWP services are discussed.

The Efficacy of Be a Mom, a Web-Based Intervention to Prevent Postpartum Depression: Examining Mechanisms of Change in a Randomized Controlled Trial

Postpartum depression (PPD) is treatable and preventable, but most women do not seek professional help for their perinatal depressive symptoms. One increasingly popular approach of improving access to care is the use of web-based intervention programs. The objective of this study was 2-fold: first, to assess the efficacy of Be a Mom, a brief web-based selective or indicated preventive intervention, in reducing depressive and anxiety symptoms of women at high risk for PPD; and second, to examine mechanisms of change linking modifiable self-regulatory skills (ie, emotion regulation, self-compassion, and psychological flexibility) to improved perinatal mental health outcomes. This 2-arm, open-label randomized controlled trial involved a sample of 1053 perinatal women presenting high risk for PPD who were allocated to the Be a Mom intervention group or a waitlist control group and completed self-report measures at baseline and postintervention assessments. Univariate latent change score models were computed to determine changes over time in adjustment processes and outcomes, with a multigroup-model approach to detect differences between the intervention and control groups and a 2-wave latent change score model to examine whether changes in processes were related to changes in outcomes. Be a Mom was found to be effective in reducing depressive (intervention group: µΔ=-3.35; P<.001 vs control group: µΔ=-1.48; P<.001) and anxiety symptoms (intervention group: µΔ=-2.24; P<.001 vs control group: µΔ=-0.43; P=.04) in comparison with the control group, where such changes were inexistent or much smaller. All 3 psychological processes under study improved statistically significantly in posttreatment assessments: emotion regulation ability (Δχ23=12.3; P=.007) and psychological flexibility (Δχ23=34.9; P<.001) improved only in the intervention group, and although self-compassion increased in both groups (Δχ23=65.6; P<.001), these improvements were considerably greater in the intervention group. These results suggest that Be a Mom, a low-intensity cognitive behavioral therapy program, is a promising first-line intervention for helping perinatal women, particularly those with early-onset PPD symptoms. ClinicalTrials.gov NCT03024645; https://clinicaltrials.gov/ct2/show/NCT03024645.

What guides guided self‐help? Recognising the role of formulation in Low Intensity CBT

AbstractThe emphasis on formulation, as a lynchpin and driver of cognitive behavior therapy (CBT) has received increasing attention, consensus of value among practitioners and emerging studies of efficacy. The terms, “formulation” and “conceptualisation” are frequently used interchangeably in literature which is exclusively focussed on high intensity CBT. In contrast, little has been included on the value or recognising the existence of formulation, for Low Intensity CBT practitioners providing guided self‐help. This may contribute to misconceptions that Low Intensity CBT is a mechanistic set of techniques. Links to CBT competencies, curricula, role of supervision and roots in UK Behavioral Nurse Therapist training, are made to highlight the implicit presence of Low Intensity formulation. We suggest a definition of formulation, as a key Low Intensity competency. This uses an individualised treatment rationale and problem statement, derived from a structured functional assessment. We propose, explicitly emphasising these, constitutes Low Intensity case formulation, which guides intervention. This is a refocus of existing practice, not introduction of completely new elements. A brief illustration of “how to” deliver formulation‐driven Low Intensity CBT is made. This promotes a concise “within‐session” and “between‐session” thread. This adjustment, on what guides Low Intensity interventions, is relevant to practitioners, supervisors and trainers in promoting Low Intensity best practice. This argues that recognising the value of formulation assists in optimising skills development, client outcomes and satisfaction with Low Intensity CBT. Cautions with the approach and the need for further research are noted.

A brief transdiagnostic group (the take control course) compared to individual low-intensity CBT for depression and anxiety: a randomized non-inferiority trial

ABSTRACT Few studies have examined brief transdiagnostic groups. The Take Control Course (TCC) was developed for patients with mild to moderate common mental health problems. We examined whether TCC is non-inferior to individual low-intensity cognitive behaviour therapy (CBT) in a single-blind individually randomised parallel non-inferiority trial. The primary outcomes were depression (PHQ9) and anxiety (GAD7) at 6-month follow-up (primary outcome point) and 12-month follow-up. The non-inferiority margin that we set, based on previous trials, corresponds to approximately 3 points on the PHQ9 and approximately 2.5 points on the GAD7. Intention-to-treat (ITT) and per-protocol (PP) analyses of 6-month data of 156 randomised patients indicated that TCC was non-inferior to individual low-intensity CBT on anxiety (ITT Coefficient = 0.24; 95% CI: −1.45 to 1.92; d = 0.04; p = .79), and depression (ITT Coefficient = 0.82; 95% CI: −1.06 to 2.69; d = 0.14; p = .39) outcomes, and functioning (ITT Coefficient = 0.69; 95% CI: −2.56 to 3.94; d = 0.08; p = .68). The findings at 12 months were inconclusive and require further testing. This randomised trial provides preliminary support that TCC is not less effective than short-term individual CBT within Improving Access to Psychological Therapies (IAPT) services.

The CALM trial protocol: a randomised controlled trial of a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children

BackgroundGlobally, around 13% of children experience dental anxiety (DA). This group of patients frequently miss dental appointments, have greater reliance on treatment under general anaesthesia (GA) and have poorer oral health-related quality of life (OHRQoL) than their non-dentally anxious peers. Recently, a low-intensity cognitive behavioural therapy (CBT)-based, self-help approach has been recommended for management of childhood anxiety disorders. A feasibility study conducted in secondary care found this guided self-help CBT resource reduced DA and a randomised controlled trial was recommended. The present study aims to establish the clinical and cost-effectiveness of a guided self-help CBT intervention to reduce DA in children attending primary dental care sites compared to usual care.MethodsThis 4-year randomised controlled trial will involve 600 children (aged 9–16 years) and their parent/carers in 30 UK primary dental care sites. At least two dental professionals will participate in each site. They will be assigned, using random allocation, to receive the CBT training and deliver the intervention or to deliver usual care. Children with DA attending these sites, in need of treatment, will be randomly allocated to be treated either by the intervention (CBT) or control (usual care) dental professional. Children will complete questionnaires relating to DA, OHRQoL and HRQoL before treatment, immediately after treatment completion and 12 months post-randomisation. Attendance, need for sedation/GA and costs of the two different approaches will be compared. The primary outcome, DA, will be measured using the Modified Child Dental Anxiety Scale. Scores will be compared between groups using a linear mixed model.DiscussionTreating dentally anxious patients can be challenging and costly. Consequently, these children are frequently referred to specialist services for pharmacological interventions. Longer waiting times and greater travel distances may then compound existing healthcare inequalities. This research will investigate whether the intervention has the potential to reduce DA and improve oral health outcomes in children over their life-course, as well as upskilling primary dental healthcare professionals to better manage this patient group.Trial registrationThis clinical trial has been registered with an international registry and has been allocated an International Standard Randomised Controlled Trial Number (ISRCTN27579420).

Study protocol and methods for Easing Pelvic Pain Interventions Clinical Research Program (EPPIC): a randomized clinical trial of brief, low-intensity, transdiagnostic cognitive behavioral therapy vs education/support for urologic chronic pelvic pain syndrome (UCPPS)

BackgroundUrologic chronic pelvic pain syndrome (UCPPS) encompasses several common, costly, diagnoses including interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome that are poorly understood and inadequately treated with conventional medical therapies. Behavioral strategies, recommended as a first-line treatment for managing symptoms, are largely inaccessible, time and labor intensive, and technically complex. The Easing Pelvic Pain Interventions Clinical Research Program (EPPIC) is a clinical trial examining the efficacy of low-intensity cognitive behavioral therapy (Minimal Contact CBT or MC-CBT) for UCPPS and its durability 3 and 6 months post treatment. Additional aims include characterizing the operative processes (e.g., cognitive distancing, context sensitivity, coping flexibility, repetitive negative thought) that drive MC-CBT-induced symptom relief and pre-treatment patient variables that moderate differential response.MethodsUCPPS patients (240) ages 18–70 years, any gender, ethnicity, and race, will be randomized to 4-session MC-CBT or a credible, non-specific education comparator (EDU) that controls for the generic effects from simply going to treatment. Efficacy assessments will be administered at pre-treatment, 2 weeks, and 3 and 6 months post treatment-week acute phase. A novel statistical approach applied to micro-analytic mediator assessment schedule will permit the specification of the most effective CBT component(s) that drive symptom relief.DiscussionEmpirical validation of a low-intensity self-management therapy transdiagnostic in scope has the potential to improve the health of chronic pelvic pain patients refractory to medical therapies, reduce social and economic costs, conserve health care resources, as well as inform evidence-based practice guidelines. Identification of change mechanisms and moderators of treatment effects can provide proactive patient-treatment matching fundamental to goals of personalized medicine.Trial RegistrationClinicaltrials.gov NCT05127616. Registered on 9/19/21.

Remote cognitive-behavioral therapy for generalized anxiety disorder: A preliminary meta-analysis.

Generalized anxiety disorder (GAD) is a chronic mental health condition that results in significant individual, societal, and economic burden. While cognitive behavioral therapy (CBT) is well established as an efficacious treatment for GAD, individuals have identified several logistical barriers to accessing face-to-face CBT. Remotely delivered treatments address many of these treatment barriers. The aim of the current study was to synthesize the current literature on the efficacy of remote CBT for GAD using a meta-analytic approach. Relevant articles were identified through an electronic database search and 10studies (with 11 remote conditions and 1071 participants) were included in the meta-analysis. Within-group findings indicate that remote CBT for GAD results in large effect sizes from pretreatment to posttreatment (g = 1.30; 95% confidence interval[CI]: 1.03-1.58). Both low intensity and high intensity remote CBT interventions were found to result in large effect sizes (g = 1.36; 95% CI: 1.11-1.61 and g = 0.83; 95% CI: 0.20-1.47, respectively), with no significant differences between the treatment formats (Q1 = 2.28, p = 0.13). Between-group effect sizes were medium in size at posttreatment (g = 0.76; 95% CI: 0.47-1.06). These findings have potential implications for the delivery of evidence-based treatment for GAD and the inclusion of remote methods in stepped care treatment approaches.

The effect of personalised versus non-personalised study invitations on recruitment within the ENGAGE feasibility trial: an embedded randomised controlled recruitment trial

BackgroundRecruitment into clinical trials is challenging and there is a lack of evidence on effective recruitment strategies. Personalisation of invitation letters is a potentially pragmatic and feasible way of increasing recruitment rates at a low-cost. However, there is a lack of evidence concerning the effect of personalising of study invitation letters on recruitment rates.MethodsWe undertook a Study Within A Trial (SWAT) to investigate the effect of personalised versus non-personalised study invitation letters on recruitment rates into the host feasibility trial ENGAGE, a feasibility study of an internet-administered, guided, Low Intensity Cognitive-Behavioural Therapy based self-help intervention for parents of children previously treated for cancer. An intervention group (n = 254) received a personalised study invitation letter and the control group (n = 255) received a non-personalised study invitation letter. The primary outcome was the proportion of participants in the intervention group and the control group enrolled into the ENGAGE host feasibility trial. Secondary outcomes relating to the recruitment and screening process, and retention were examined. Differences in proportions between groups for the primary and secondary outcomes were estimated using logistic regression.ResultsOf the 509 potential participants, 56 (11.0%) were enrolled into the ENGAGE host feasibility trial: personalised: 30/254 (11.8%) and non-personalised: 26/255 (10.2%). No statistically significant effect on personalisation of enrolment was found (OR 1.18, 95% CI 0.68–2.06). No statistically significant differences were found for any secondary outcome.ConclusionsPersonalisation of study invitations had no effect on recruitment. However, given the small study sample size in the present SWAT, and lack of similar embedded recruitment RCTs to enable a meta-analysis, additional SWATs to examine the personalisation of study invitation letters are warranted.Trial registrationISRCTN57233429; ISRCTN18404129; SWAT 112, Northern Ireland Hub for Trials Methodology Research SWAT repository (2018 OCT 1 1231) (https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,939618,en.pdf).

A qualitative examination of low-intensity cognitive behaviour therapy to reduce anxiety and depression during the COVID-19 pandemic

ABSTRACT Objective The COVID-19 pandemic has had a severe impact on mental health. There is an urgent need to deliver low-intensity cognitive behaviour therapy (CBT) tailored to mitigate the impacts of the pandemic. The aim was to engage in a qualitative study of participants’ views surrounding anxiety and depression during the pandemic and feedback on the acceptability and usefulness of a low-intensity CBT intervention during the pandemic to inform intervention development and refinement. Method There were 21 participants (21–80 years, M = 40.90 years, SD = 16.33; 71% female) from Australia who participated in qualitative interviews who had completed low-intensity CBT for anxiety and depression during the pandemic. Results Themes emerged including the negative impact of the pandemic on mental health, prior experience of psychological therapy, acceptability, and usefulness of the intervention, participants’ ideas for intervention improvement, and preferences for using the guide. The majority of participants reported the intervention was useful, however, suggested several areas including content and format to improve the intervention and feedback on what they would prefer for an intervention. Conclusions A low-intensity CBT intervention was reported as useful and acceptable by participants for their concerns related to the pandemic and exacerbation of pre-existing anxiety and depression.

\u2018Asking for help\u2019: a qualitative interview study exploring the experiences of interpersonal counselling (IPC) compared to low-intensity cognitive behavioural therapy (CBT) for women with depression during pregnancy

BackgroundTreating depression early in pregnancy can improve health outcomes for women and their children. Current low-intensity psychological therapy for perinatal depression is a supported self-help approach informed by cognitive behavioural therapy (CBT) principles. Interpersonal counselling (IPC) may be a more appropriate low-intensity talking therapy for addressing the problems experienced by pregnant women with depression. A randomised feasibility trial (ADAGIO) has compared the acceptability of offering IPC for mild-moderate antenatal depression in routine NHS services compared to low-intensity CBT. This paper reports on a nested qualitative study which explored women’s views and expectations of therapy, experiences of receiving IPC, and Psychological Wellbeing Practitioners (PWPs - junior mental health workers) views of delivering the low-intensity therapy.MethodsA qualitative study design using in-depth semi-structured interviews and focus groups. Thirty-two pregnant women received talking therapy within the ADAGIO trial; 19 contributed to the interview study from July 2019 to January 2020; 12 who had IPC and seven who had CBT. All six PWPs trained in IPC took part in a focus group or interview. Interviews and focus groups were recorded, transcribed, anonymised, and analysed using thematic methods.ResultsPregnant women welcomed being asked about their mental health in pregnancy and having the chance to have support in accessing therapy. The IPC approach helped women to identify triggers for depression and explored relationships using strategies such as ‘promoting self-awareness through mood timelines’, ‘identifying their circles of support’, ‘developing communication skills and reciprocity in relationships’, and ‘asking for help’. PWPs compared how IPC differed from their prior experiences of delivering low-intensity CBT. They reported that IPC included a useful additional emotional component which was relevant to the perinatal period.ConclusionsIdentifying and treating depression in pregnancy is important for the future health of both mother and child. Low-intensity perinatal-specific talking therapies delivered by psychological wellbeing practitioners in routine NHS primary care services in England are acceptable to pregnant women with mild-moderate depression. The strategies used in IPC to manage depression, including identifying triggers for low mood, and communicating the need for help, may be particularly appropriate for the perinatal period.Trial registrationISRCTN 11513120. 02/05/2019.

Interpersonal counselling versus perinatal-specific cognitive behavioural therapy for women with depression during pregnancy offered in routine psychological treatment services: a phase II randomised trial

BackgroundUp to one in eight women experience depression during pregnancy. In the UK, low intensity cognitive behavioural therapy (CBT) is the main psychological treatment offered for those with mild or moderate depression and is recommended during the perinatal period, however referral by midwives and take up of treatment by pregnant women is extremely low.Interpersonal Counselling (IPC) is a brief, low-intensity form of Interpersonal Psychotherapy (IPT) that focuses on areas of concern to service users during pregnancy.To improve psychological treatment for depression during pregnancy, the study aimed to assess the feasibility and acceptability of a trial of IPC for antenatal depression in routine NHS services compared to low intensity perinatal specific CBT.MethodsWe conducted a small randomised controlled trial in two centres. A total of 52 pregnant women with mild or moderate depression were randomised to receive 6 sessions of IPC or perinatal specific CBT. Treatment was provided by 12 junior mental health workers (jMHW). The primary outcome was the number of women recruited to the point of randomisation. Secondary outcomes included maternal mood, couple functioning, attachment, functioning, treatment adherence, and participant and staff acceptability.ResultsThe study was feasible and acceptable. Recruitment was successful through scanning clinics, only 6 of the 52 women were recruited through midwives. 71% of women in IPC completed treatment. Women reported IPC was acceptable, and supervisors reported high treatment competence in IPC arm by jMHWs. Outcome measures indicated there was improvement in mood in both groups (Change in EPDS score IPC 4.4 (s.d. 5.1) and CBT 4.0 (s.d. 4.8).ConclusionsThis was a feasibility study and was not large enough to detect important differences between IPC and perinatal specific CBT. A full-scale trial of IPC for antenatal depression in routine IAPT services is feasible.Trial registrationThis study has been registered with ISRCTN registry 11513120. – date of registration 05/04/2018.

Conducting Digital Health Care Research: Document Analysis of Challenges Experienced During Intervention Development and Feasibility Study Setup of an Internet-Administered Intervention for Parents of Children Treated for Cancer.

BackgroundThe design and conduct of research to develop, test, and evaluate complex health care interventions is challenging. Although the existing literature describes key challenges associated with the design and conduct of definitive (evaluation) trials, there is a lack of information concerning specific challenges associated with the intervention development phase and setup of feasibility studies. In particular, the literature is scarce concerning the challenges associated with conducting digital health care research, such as research on internet-administered interventions and research using digital features to support the execution of study procedures (eg, recruitment, consent, retention, and data collection and management). This study is conducted in the context of the intervention development and feasibility study setup phases of an internet-administered, guided, low-intensity cognitive behavioral therapy–based intervention for parents of children previously treated for cancer.ObjectiveThe aim of this study is to explore the challenges experienced during the development phase of the internet-administered intervention and digital features to support the execution of the study procedures and a feasibility study setup.MethodsTo explore the key challenges experienced, we conducted a document analysis of written records from all study meetings held by the research team (meeting minutes) between June 7, 2018, and January 10, 2020, guided by a thematic analysis approach. Furthermore, discussion groups with members of the research team were held to develop a more detailed understanding of the key challenges experienced. Methods and results are reported in accordance with the relevant items from the Standards for Reporting Qualitative Research checklist.ResultsSix main themes were identified: decision-making and communication, expertise, external constraints, flexibility, planning and scheduling, and technical constraints.ConclusionsSignificant challenges were experienced during the intervention development and setup phases of the feasibility study. Implications are discussed to inform future design, conduct, and planning of internet-administered intervention development and feasibility studies, especially within the context of digital health care research.

The Functionality of Mobile Apps for Anxiety: Systematic Search and Analysis of Engagement and Tailoring Features.

BackgroundA range of mobile apps for anxiety have been developed in response to the high prevalence of anxiety disorders. Although the number of publicly available apps for anxiety is increasing, attrition rates among mobile apps are high. These apps must be engaging and relevant to end users to be effective; thus, engagement features and the ability to tailor delivery to the needs of individual users are key. However, our understanding of the functionality of these apps concerning engagement and tailoring features is limited.ObjectiveThe aim of this study is to review how cognitive behavioral elements are delivered by anxiety apps and their functionalities to support user engagement and tailoring based on user needs.MethodsA systematic search for anxiety apps described as being based on cognitive behavioral therapy (CBT) was conducted on Android and iPhone marketplaces. Apps were included if they mentioned the use of CBT for anxiety-related disorders. We identified 597 apps, of which 36 met the inclusion criteria and were reviewed through direct use.ResultsCognitive behavioral apps for anxiety incorporate a variety of functionalities, offer several engagement features, and integrate low-intensity CBT exercises. However, the provision of features to support engagement is highly uneven, and support is provided only for low-intensity CBT treatment. Cognitive behavioral elements combine various modalities to deliver intervention content and support the interactive delivery of these elements. Options for personalization are limited and restricted to goal selection upon beginning use or based on self-monitoring entries. Apps do not appear to provide individualized content to users based on their input.ConclusionsEngagement and tailoring features can be significantly expanded in existing apps, which make limited use of social features and clinical support and do not use sophisticated features such as personalization based on sensor data. To guide the evolution of these interventions, further research is needed to explore the effectiveness of different types of engagement features and approaches to tailoring therapeutic content.

Internet-Administered Cognitive Behavioral Therapy for Common Mental Health Difficulties in Parents of Children Treated for Cancer: Intervention Development and Description Study.

BackgroundFollowing the end of a child’s treatment for cancer, parents may report psychological distress. However, there is a lack of evidence-based interventions that are tailored to the population, and psychological support needs are commonly unmet. An internet-administered low-intensity cognitive behavioral therapy (LICBT)–based intervention (EJDeR [internetbaserad självhjälp för föräldrar till barn som avslutat en behandling mot cancer]) may provide a solution. ObjectiveThe first objective is to provide an overview of a multimethod approach that was used to inform the development of the EJDeR intervention. The second objective is to provide a detailed description of the EJDeR intervention in accordance with the Template for Intervention Description and Replication (TIDieR) checklist.MethodsEJDeR was developed through a multimethod approach, which included the use of existing evidence, the conceptualization of distress, participatory action research, a cross-sectional survey, and professional and public involvement. Depending on the main presenting difficulty identified during assessment, LICBT behavioral activation or worry management treatment protocols are adopted for the treatment of depression or generalized anxiety disorder when experienced individually or when comorbid. EJDeR is delivered via the Uppsala University Psychosocial Care Programme (U-CARE) portal, a web-based platform that is designed to deliver internet-administered LICBT interventions and includes secure videoconferencing. To guide parents in the use of EJDeR, weekly written messages via the portal are provided by e-therapists comprising final year psychology program students with training in cognitive behavioral therapy.ResultsAn overview of the development process and a description of EJDeR, which was informed by the TIDieR checklist, are presented. Adaptations that were made in response to public involvement are highlighted.ConclusionsEJDeR represents a novel, guided, internet-administered LICBT intervention for supporting parents of children treated for cancer. Adopting the TIDieR checklist offers the potential to enhance fidelity to the intervention protocol and facilitate later implementation. The intervention is currently being tested in a feasibility study (the ENGAGE study).International Registered Report Identifier (IRRID)RR2-10.1136/bmjopen-2018-023708

Unguided low intensity cognitive behaviour therapy for anxiety and depression during the COVID-19 pandemic: A randomised trial

The COVID-19 pandemic has had a severe impact on mental health worldwide, with increased rates of anxiety and depression widely documented. The aim of this study was to examine unguided low intensity cognitive behaviour therapy for anxiety and depression during the pandemic. A sample of 225 individuals in Australia and the United Kingdom (M age 37.79, SD = 14.02, range 18–80 years; 85% female) were randomised into intervention or waitlist control. The intervention group demonstrated significant decreases in anxiety (d = 0.36 [0.18, 0.54]) and depression (d = 0.28 [0.11, 0.45]) compared to controls. The majority of participants (96%) rated the intervention as useful, and most (83%) reported they spent 30 min or less reading the guide, with 83% agreeing the intervention was easy to read. The results indicate that low intensity cognitive behaviour therapy has efficacy in reducing anxiety and depression during the COVID-19 pandemic. There is an urgent need to disseminate low intensity psychological therapies to improve mental health in this challenging time.