Introduction Cognitive behavioral therapy (CBT) is effective for major depressive disorder (MDD), yet individual responses vary. Personality may relate to outcomes, but its role in brooding rumination during CBT remains unclear. This study tested whether baseline personality traits are associated with brooding change in patients with MDD receiving CBT. Methods In this prospective observational cohort, 75 outpatients were allocated to CBT + treatment-as-usual (TAU) (n=33 baseline; n=30 longitudinal) or TAU alone (n=42; n=38) based on clinical course and preference. The Ruminative Responses Scale (RRS) brooding subscale and the 17-item Grid-Based Hamilton Depression Rating Scale (GRID-HAMD 17 ) were assessed at baseline and 16 weeks; the Temperament and Personality Questionnaire (T&P) was assessed at baseline. Multiple linear regressions within each group examined associations between baseline traits and brooding change, adjusting for sex, baseline brooding, and baseline GRID-HAMD 17 . A trait-wise single-predictor sensitivity analysis used the same covariates. Results Both groups demonstrated significant within-group improvements. Hedges’ g (95% CI): CBT—brooding 0.48 (0.11–0.85), GRID-HAMD 17 1.07 (0.63–1.50); TAU—brooding 0.84 (0.47–1.21), GRID-HAMD 17 1.46 (1.01–1.91). In CBT, higher anxious worrying was associated with greater brooding reduction (eight-predictor model: B = 0.71, p = 0.026) and remained significant in the single-predictor analysis (B = 0.36, p = 0.014). Self-criticism showed a negative association in the eight-predictor model (B=−0.60, p = 0.043) but did not persist in the single-predictor analysis. In TAU, no personality trait was associated with brooding change. Adjusted between-group differences in change (brooding, GRID-HAMD 17 , total DDD) were not significant. Limitations Nonrandomized allocation, modest sample sizes, and two assessment time points limit precision and power; the eight-predictor model in CBT may be prone to overfitting, so findings are exploratory. Conclusion In this observational cohort, personality traits, with anxious worrying appearing relevant, were associated with brooding change within CBT, whereas between-group differences were not significant. These hypothesis-generating results require validation in adequately powered randomized trials to inform stratified depression care.

Substance use is sustained partly through implicit associations toward drugs - i.e. automatic positive attitudes and motivational responses toward drug-related cues. Such implicit associations may be inferred by behavioral measures that capture the relative ease, speed, or priming of those associations. However, implicit opioid associations in patients with opioid use disorder (OUD) remain underexplored, and it is unknown whether mindfulness-based interventions such as Mindfulness-Oriented Recovery Enhancement (MORE) can modify implicit associations to support recovery. We conducted secondary analyses of data from a clinical trial of adults with OUD (N=154), randomized to either methadone treatment as usual (TAU) or TAU plus MORE. Participants completed an opioid implicit association test (IAT) at baseline. Days of opioid use were tracked over 16weeks. Data were analyzed using logistic and zero-inflated negative binomial (ZINB) regressions to examine the impact of baseline IAT scores on future opioid use and MORE's moderating effect. In the TAU group, each 1-unit increase in IAT D score was associated with a 216% increase in the odds of opioid use (OR=3.16, p=0.049). However, in the MORE group, IAT scores were not significantly associated with future opioid use (OR=0.58, p=0.57). ZINB analysis revealed that each 1-unit increase in IAT D score predicted 0.96 fewer days of use in MORE relative to TAU (B=-1.25; SE=0.58; p=0.030). Implicit attitudes toward opioids predicted higher opioid use among individuals receiving methadone. However, MORE attenuated this relationship and may counteract automatic cognitive biases that sustain opioid use.

Background/Objectives: Anxiety disorders (ADs) affect up to 20% of mothers in the postpartum period, characterized by psychological symptoms (e.g., emotion dysregulation; ER) and physical symptoms (e.g., disrupted bodily awareness). Although Cognitive Behavioural Therapy effectively reduces anxiety and mood symptoms, it shows limited efficacy in addressing ER difficulties and rarely targets interoceptive dysfunction—both common in postpartum ADs. This study evaluates the effectiveness of a brief mindfulness-based intervention in improving anxiety, ER, and interoception in mothers with postpartum ADs. A secondary aim is to examine changes in brain connectivity associated with these domains. Methods: This protocol describes a proof-of-concept randomized controlled trial involving 50 postpartum mothers with ADs. Participants will be randomized to receive either a 4-week mindfulness intervention plus treatment-as-usual (TAU) or TAU alone. Participants in the mindfulness + TAU group will complete a virtual 4-week group intervention adapted from Mindfulness-Based Cognitive Therapy. The TAU group will receive usual care for 4 weeks and then be offered the mindfulness intervention. Self-report measures of anxiety, ER, and interoception will be collected at baseline, post-intervention, and at a 3-month follow-up. Resting-state functional MRI will be conducted at baseline and post-intervention to assess functional connectivity changes. This trial has been registered on ClinicalTrials.gov (NCT07262801). Results: Improvements in anxiety, ER, and interoception are anticipated, along with decreased default mode network, and increased salience network connectivity post-intervention is hypothesized. Conclusions: This study will be the first to examine the combined psychological and neural effects of mindfulness in postpartum ADs, offering a potentially scalable mind–body treatment.

BackgroundParkinson disease (PD), a progressive neurodegenerative disorder, lacks disease-modifying treatments. Current therapies focus on symptomatic relief, highlighting the need for adjunctive neuroprotective strategies. Ayurveda, a holistic system, shows promise in improving PD clinical outcomes.ObjectiveThis assessor-blinded randomized controlled study aims to systematically evaluate the efficacy of an add-on Ayurveda therapeutic regimen compared to conventional treatment as usual (TAU) in improving the clinical outcomes of PD.MethodsA total of 80 patients with PD, diagnosed according to UK Parkinson’s Disease Society Brain Bank criteria, will be randomized into two groups: TAU and add-on Ayurveda. The intervention group will receive Ayurvedic therapy alongside conventional treatment for 180 days, whereas the control group will continue TAU. Assessments will occur at baseline and at 60-, 120-, and 180-day follow-ups, evaluating motor and nonmotor symptoms. Transcranial magnetic stimulation, heart rate variability, and pulmonary function tests will assess cortical excitability, autonomic function, and pulmonary function, respectively. Immunological parameters, including cytokine levels and telomere length, will be analyzed at baseline and at 180 days to explore disease-modifying effects. Liver and renal function tests will monitor safety.ResultsAs of 2025, a total of 259 patients with PD have been screened for eligibility, of whom 58 participants have been successfully enrolled in the trial. Among these, 33 participants have completed the intervention and follow-up assessments, 14 have discontinued participation, and 11 are currently continuing participation in the study. Recruitment and follow-up are ongoing, and the trial is scheduled for completion in September 2026.ConclusionsThis study aims to address the lack of mechanistic evidence and robust data on Ayurveda in PD. By systematically evaluating clinical efficacy and potential biomechanisms, the findings will provide preliminary evidence for Ayurvedic interventions, potentially paving the way for their integration into comprehensive PD management.

BackgroundAutistic adults constitute a growing and largely overlooked population with limited clinical and research resources. Social cognitive impairments are key deficits faced by this population, significantly impacting social interactions, educational and vocational functioning, and quality of life. Interventions targeting social cognition in autistic adults have shown promising results. Recent studies investigating the effect of virtual reality (VR)–based interventions for autistic adults have provided preliminary evidence supporting the feasibility and effectiveness of using this innovative technology. These studies indicate that VR interventions can enhance functional and social skills and improve specific neurocognitive and social cognitive functions. However, large-scale randomized clinical trials are urgently needed to fully assess the effectiveness of VR-based interventions for autistic adults.ObjectiveThis protocol aims to provide a comprehensive description of the design and methodology of the STEPS (Social Cognitive Training Enhancing Pro-Functional Skills) trial.MethodsSTEPS is a clinical, randomized, assessor-blinded, parallel-group superiority trial. A total of 140 participants will be allocated to receive either virtual reality–based social cognitive training (VRSCT) + treatment as usual (TAU) or TAU alone. The experimental group will receive 12 weekly 1-hour sessions of VRSCT, aiming at improving psychosocial functioning and social cognition through exposure to virtual social environments. The intervention comprises 3 core modules, namely emotions, social understanding, and complex social interactions. The exact content and duration of TAU received by each participant will be mapped and documented upon trial completion. Assessments will be conducted at baseline, at cessation of the intervention (3 months post baseline), and at 6 months post baseline.ResultsParticipant enrollment began in May 2024. As of February 2025 (initial manuscript submission), 34 participants had been enrolled, increasing to 97 participants as of December 2025. Completion of enrollment is expected in April 2026. Data analysis is expected to begin in October 2026 following the final 6-month follow-up assessment. Results are anticipated in December 2026 and will be disseminated through peer-reviewed publications.ConclusionsTo our knowledge, STEPS is the hitherto largest randomized clinical trial globally investigating the effect of VRSCT for autistic adults. The results of this innovative intervention approach may significantly advance research in the field of autism. VRSCT holds potential to improve psychosocial functioning, quality of life, and co-occurring clinical symptoms, and to reduce social cognitive deficits in autistic adults. Establishing evidence-based interventions is crucial for addressing the debilitating psychosocial challenges faced by this population, especially considering the absence of established gold-standard treatments.

Psychological intervention for postpartum depression: A systematic review and network meta-analysis.

The relational approach to treating self-harm (RELATE): A feasibility randomised controlled trial of cognitive analytic therapy for adults who self-harm versus treatment at usual.

Addressing PTSD symptoms in first responders and healthcare workers through trauma-focused treatment in Employee Assistance Programs: Protocol for a randomized controlled trial.

ABSTRACT Background: Prior exposure to traumatic events significantly increases the risk of developing substance use disorders (SUD), while having SUD, in turn, elevates the likelihood of encountering additional traumatic events. Despite this relationship, the consequences of trauma frequently go undetected and untreated in this population. The trauma-focused intervention eye movement desensitisation and reprocessing (EMDR), a first-line treatment for post-traumatic stress disorder (PTSD), has shown promising therapeutic potential in SUD patients. However, its underlying neurobiological mechanisms remain unclear. This study aims to investigate the efficacy of EMDR in SUD patients with comorbid psychological trauma. Additionally, potential mechanisms of action of the intervention will be explored. The primary hypothesis is that integrating EMDR into standard SUD treatment will enhance substance use prognosis. Methods: Sixty-four patients with SUD and trauma symptomatology will be randomised into two groups. One group will receive EMDR trauma-focused intervention in 6-8 sessions alongside treatment as usual (TAU) (n = 32), while the control group will receive TAU only (n = 32). The primary outcome will be the time to relapse, assessed at baseline, immediately after treatment, and at 1- and 3-months follow-up. Additional measures include post-traumatic, anxiety, depressive symptoms and biological markers (hair/salivary cortisol levels, eye blink conditioning, and resting-state fMRI). Survival analysis and linear mixed models will be used to assess treatment effects. The trial is registered on ClinicalTrials.gov (NCT05488691). Discussion: This study addresses a critical gap in scientific literature and clinical practice by evaluating the efficacy of EMDR, in patients with SUD and comorbid trauma symptoms, through a combination of clinical and biological markers. The findings could lead to integration of personalised, trauma-focused interventions into public health services for patients with SUD.

Autism spectrum disorder (ASD) is a neurodevelopmental condition marked by social communication deficits and restricted, repetitive behaviors. Among evidence-based practices (EBPs), interventions grounded in applied behavior analysis (ABA) principles-including Early Intensive Behavioral Intervention and naturalistic developmental behavioral interventions-are widely used. While the evidence suggests potential benefits, the findings are inconsistent, most studies carry a high risk of bias, and the quality of evidence is generally low to very low. Gaps also remain in comparisons with treatment as usual (TAU) and across intervention intensities. This mixed-methods systematic review and meta-analysis evaluated the quantitative effectiveness and qualitative experiences of ABA-based interventions for children and adolescents with ASD, addressing the methodological limitations of earlier studies, and examining comparisons with TAU. Seven databases were searched up to August 2023 following the PRISMA guidelines. Twenty-five studies met the inclusion criteria (16 randomized controlled trials, 9 qualitative). The quantitative outcomes included adaptive behavior, cognitive ability (IQ/DQ), language, daily living skills, socialization, joint attention, and autism symptom severity. Qualitative studies explored parents' and practitioners' experiences. Random-effects models were used, with subgroup analyses by intervention intensity and TAU comparisons. The meta-analysis revealed significant improvements in adaptive behavior (SMD = 0.31, 95% CI: 0.04-0.59, GRADE = low), daily living skills (SMD = 0.36, 95% CI: 0.08-0.64, GRADE = low), language skills (SMD = 0.42, 95% CI: 0.24-0.60, GRADE = moderate), and joint attention behavior (SMD = 0.27, 95% CI: 0.04-0.49, GRADE = low) compared with the controls. High-intensity interventions had a notably greater effect on language skills (SMD = 0.72, 95% CI: 0.42-1.01) than low-intensity interventions (SMD = 0.34, 95% CI: 0.13-0.55). Comparisons with TAU revealed significant effects on adaptive behavior (SMD = 0.34, 95% CI: 0.02-0.66), daily living skills (SMD = 0.39, 95% CI: 0.07-0.71), and language skills (SMD = 0.51, 95% CI: 0.24-0.78). Qualitative findings highlighted perceived family and practitioner benefits but also barriers such as financial constraints and variability in training quality. This study confirms the effectiveness of ABA in improving developmental and behavioral outcomes in children with ASD. However, systemic challenges and variability in outcomes underscore the need for targeted policy initiatives, enhanced training programs, and further research on the impact of ABA on core ASD symptoms.

An increasing number of children and adolescents are prescribed second-generation antipsychotic medications, which may lead to cardiometabolic or other physical health impairments. It is unknown whether lifestyle interventions can prevent or manage these adverse effects. To evaluate the effectiveness of lifestyle interventions for preventing or managing cardiometabolic risks and other adverse physical health outcomes in this population. Four bibliographic databases were searched up to February 2024. Randomised controlled trials reporting a physical health outcome of children or adolescents (aged 6-17 years) taking antipsychotics and participating in a lifestyle intervention compared with treatment as usual (TAU) were eligible for inclusion. The Cochrane Risk of Bias 2 tool was used to assess risk of bias. Data were synthesised via a random-effects meta-analysis and narrative synthesis. Four studies with a total of 370 participants were included. Most (75%) had a high risk of bias. Lifestyle interventions resulted in moderate but statistically non-significant reductions in participants' body mass index (standard mean difference -0.70, 95% CI: -1.70 to 0.31) compared with TAU. Some studies reported improvements in other physical health outcomes favouring the intervention, although findings were inconsistent and varied across different measures. Reporting of secondary indicators of physical health, including participant or family health behaviours, was limited. The effectiveness of lifestyle interventions for preventing or managing the cardiometabolic risk and other adverse physical health outcomes in this population is unclear due to the limited number of available trials, small samples and high risk of bias. Larger trials are needed.

One treatment does not fit all: Indications that spinning therapy benefits only a subgroup of patients with depression characterized by a T memory cell inflation profile.

Mental healthcare is under pressure, resulting in prolonged waiting lists for treatment. This is problematic, as time spent on a waiting list is associated with suboptimal recovery, more treatment dropout, and increased societal costs. An online transdiagnostic positive psychology intervention (eHealth PPI) may increase resilience (i.e., the ability to adapt to challenging experiences) and well-being among patients. Offering the same intervention to loved ones could be a novel contribution to enhancing positive effects among patients and loved ones. A study protocol is presented aimed at examining the clinical effectiveness, cost-effectiveness and implementation procedures of an eHealth PPI for patients with various mental health complaints awaiting treatment and their loved ones. Using two studies, the current manuscript proposes a threefold evaluation of an eHealth PPI consisting of 9 modules, focusing on: [1] clinical effectiveness, [2] economic evaluation, and [3] implementation procedures. To evaluate the procedural implementation of the eHealth PPI from a user-perspective, a replicated single-case design (RSCD) will be performed in study 1, with measurements at baseline, after each module, and post-intervention. In study 2, a randomized controlled trial (RCT) will be used to examine the clinical effectiveness, cost-effectiveness and implementation procedures of the eHealth PPI, using three arms: [1] PPI during the waiting period for patients, [2] PPI during the waiting period for patients and loved ones, and [3] treatment as usual (TAU), i.e., the conventional waiting period for patients. Following the waiting period, patients will receive a mental health treatment as usual. Study 2 will employ measurements at baseline, post-intervention, after 3, 6, and 9 months, 1 year following PPI completion, and 1 year following treatment completion. A key outcome is positive mental health, consisting of emotional, social, and psychological wellbeing. Other outcomes include, for instance, resilience, psychological complaints, quality of life, societal costs, and adherence. Introducing a transdiagnostic eHealth PPI to various patients awaiting mental health treatment and their loved ones may improve treatment outcomes. Enhancing resilience through an eHealth PPI may reduce healthcare costs and health-related societal costs, potentially making it a cost-effective strategy compared to TAU. NL-OMON57370. Registered in the Overview of Medical Research in the Netherlands on 17 March 2025.

AVATAR therapy, a digitally supported intervention, utilises avatars to promote recovery in people who experience distressing auditory hallucinations. This approach was recently evaluated in a multicentre randomised controlled trial comparing brief (AV-BRF) and extended (AV-EXT) forms of therapy with treatment as usual (TAU). There was evidence for the effectiveness of therapy, particularly for AV-EXT. However, value for money needs to be assessed. To compare separately the cost utility of the brief and extended forms of AVATAR therapy with TAU. In a three-arm randomised controlled trial the use of health services was measured, and costs (2021/2022; pounds sterling) calculated from a health and social care perspective over a 28-week follow-up period. Quality-adjusted life years (QALYs; derived from the 5-level version of the EuroQol 5-Dimension questionnaire) were combined with costs. AV-BRF resulted in extra costs of £319 (95% CI, -£1558 to £2496), and AV-EXT in lower costs of £1965 (95% CI, -£1912 to £1519), compared with TAU. Over the follow-up, AV-BRF resulted in 0.0159 (95% CI, -0.0103 to 0.0422) and AV-EXT in 0.0173 (95% CI, -0.0049 to 0.0395) more QALYs than TAU. The cost per QALY for AV-BRF compared with TAU was £20 016, while AV-EXT dominated TAU (lower costs and more QALYs). Neither version of AVATAR had a substantial impact on QALYs. However, AV-EXT did result in reduced care costs - albeit not statistically significant - and was potentially cost-effective compared with TAU. AV-BRF had an incremental cost-effectiveness ratio that indicated lower potential cost-effectiveness. These findings are uncertain, but could still inform decision-making regarding interventions in this field.

Background: We report UK findings from Music Interventions for Depression and Dementia in Elderly care (MIDDEL), a cross-national, clustered, randomised trial undertaken in 2018-2023 to evaluate the effectiveness of music interventions for depression symptoms in care home residents living with dementia (NCT03496675, clinicaltrials.gov (accessed on 1 December 2024)). The trial compared the effects of Group Music Therapy (GMT) with Recreational Choir Singing (RCS); GMT and RCS combined; and treatment as usual (TAU). Methods: In the intervention arms, the protocolized music interventions were delivered in care home units twice per week for three months, then once per week for three months. The primary outcome was depressive symptoms after six months, measured by MADRS. Secondary outcomes included well-being-EQ-5D-5L, Visual Analogue Scale (VAS); quality of life-QOL-AD; symptoms of dementia-SIB-8, NPI-Q; and caregiver distress-NPI-Q. The change in MADRS score from baseline to 6 months was assessed using a linear mixed-effects model. We report the multivariate model having both treatments as predictors, both unadjusted and adjusted, for the interaction between the treatments. Results: The UK trial started in 2022 after the pandemic lockdown, when 16 care home units were recruited and randomised, four per arm; 192 residents aged over 65 with depression and dementia participated. An ITT analysis of 146 participants retained at 6 months found neither intervention had a significant positive effect on any outcome. Significant unfavourable effects were found for RCS participants on MADRS, NPI symptom severity, and EQ-VAS. The combination of RCS + GMT had a detrimental effect on caregiver distress. Conclusions: MIDDEL UK findings do not support the use of GMT or RCS to alleviate depression in care home residents with dementia.

Our objective was to determine the feasibility and acceptability of the Treatment and Education Approach for Childhood-onset Lupus (TEACH), a six-session cognitive behavioral intervention addressing depressive, fatigue, and pain symptoms, delivered remotely to individual youth with lupus by a trained interventionist. We expected that TEACH would be considered feasible and acceptable based on recruitment and retention rates. We also examined the effect of TEACH on youths' depressive, fatigue, and pain symptoms compared to medical treatment as usual (TAU). A pilot two-arm longitudinal randomized controlled clinical trial was conducted. Adolescents (12-17 years) and young adults (18-22 years) with childhood-onset systemic lupus erythematosus (cSLE) and elevated depressive, fatigue, and/or pain symptoms were recruited from six pediatric rheumatology sites across the United States and Canada from August 2020-March 2023.Participants were randomized 1:1 to TEACH + TAU or TAU-alone and reported symptom data at baseline and eight weeks later. Of the 200 youth approached, 97 consented to participate (48.5% recruitment). Among 64 eligible participants, 32 were randomized to TEACH + TAU, and 32 to TAU-alone. Retention was high (92.2%). At post-assessment, the intervention group demonstrated reductions in depressive (7.88 [3.20, 12.60]; 14%) and fatigue (3.91 [0.44, 7.39]; 7%) symptoms, but not pain (0.89 [-0.06, 1.84]). This remotely delivered cognitive behavioral intervention tailored to youth with lupus was feasible and associated with reduced depressive and fatigue symptoms compared with medical treatment as usual. Further increasing accessibility by implementing TEACH in medical settings may improve uptake and patient outcomes.

Auditory hallucination (AH) is a distressing and disabling symptom in patients with schizophrenia spectrum disorder, particularly in those who do not respond to antipsychotics. The aim of this study is to examine the efficacy of AVATAR (Audio Visual Assisted Therapy Aid for Refractory auditory hallucinations) therapy for medication-resistant AH in patients with schizophrenia spectrum disorder. A systematic search was conducted across five major databases for randomized controlled trials (RCTs) investigating AVATAR therapy for patients with medication-resistant AH, with control conditions such as treatment-as-usual (TAU), cognitive behavioral therapy (CBT), or supportive therapy. The primary outcome was AH severity improvement, measured by the Psychotic Symptom Rating Scale-Auditory Hallucination. The secondary outcomes were positive and negative symptoms (assessed using the Positive And Negative Syndrome Scale), quality of life, depression, anxiety, and acceptance (all-cause discontinuation). Additionally, we evaluated the long-term efficacy by examining the sustained effects after treatment discontinuation. Six RCTs (n = 675; 64.7% male; mean age 39.4 [SD 4.8] years) were included. AVATAR therapy was associated with AH improvement (mean difference [MD], -2.97; 95%CI: -4.03, -1.90) and positive symptoms reduction (MD, -1.13; 95%CI: -2.14, -0.11) compared to controls. It also showed efficacy in improving depressive symptoms, anxiety, and quality of life, with small-to-medium effect sizes. The three-month follow-up effects remained consistent with treatment effect at study endpoints across all outcomes. The all-cause discontinuation rate did not differ between AVATAR therapy and controls. Given its potential benefits, clinicians may consider implementing AVATAR therapy for patients with medication-resistant symptoms. However, the development of standardized treatment protocols or manuals is essential to ensure treatment fidelity and guide future clinical and research applications.

Depersonalization-derealization disorder (DDD) is characterized by feelings of "unreality" about the self and/or external world. Cognitive Behavioral Therapy adapted for DDD (CBT-f-DDD) has been effective in published clinical audits. This study aimed to provide feasibility and acceptability data. An individually randomized design of CBT-f-DDD versus Treatment as Usual (TAU) was carried out with adult DDD participants from NHS Trusts in London. The CBT-f-DDD group received individual sessions over a 6-month period from CBTtherapists. Qualitative interviews were conducted with CBT-f-DDD participants and their clinicians. Eight feasibility objectives were evaluated (recruitment, retention, resources, representativeness, acceptability of study design and intervention, preliminary responses to intervention, and health economics). Thirty participants with DDD were recruited over 13months. Only 63% completed the final assessment, so retention needs improvement. Resources were acceptable. The sample was comparable to previous studies, although younger, with a shorter duration of DDD and lower mean DDD scores. In a post-study questionnaire, no aspect of the study or treatment was rated unacceptable; however, some areas need improvement. Qualitative interviews with participants and clinicians recorded positive responses to CBT-f-DDD. Those in the CBT arm had a mean decrease of 16.9 points (SD 43.6) on the Cambridge Depersonalization Scale versus a mean decrease of 5.5 points (SD = 25.0) for the TAU arm. Health economics analyses found that CBT-f-DDD saved £153 per person. Participants reported an additional 0.08 Quality-Adjusted Life Years at low cost. This study suggests that a subsequent RCT for CBT-f-DDD is feasible and represents the first step in the process of establishing evidence-based treatments for DDD. However, refinements to the current design and delivery were indicated for a future fully powered definitive RCT of CBT-f-DDD. ISRCTN, ISRCTN97686121. Retrospectively registered 5 January 2023: https://doi.org/10.1186/ISRCTN97686121.

IntroductionThe primary objective of this clinical trial is to determine the clinical and cost-effectiveness of psychoeducation and emotional stabilisation (PES), together with eye movement desensitisation and reprocessing (EMDR) plus treatment-as-usual (TAU) in reducing symptoms of post-traumatic stress disorder (PTSD) among adults with intellectual disabilities compared with TAU. Secondary objectives include: (1) determining whether PES/EMDR plus TAU is superior to TAU in improving mental health problems and quality of life (QoL) among adults with intellectual disabilities who had a diagnosis of PTSD and (2) completing a process evaluation to examine intervention implementation and acceptability.MethodsThis is a two-arm parallel single-blind randomised controlled trial comparing PES-EMDR+TAU to TAU including an internal pilot phase. Outcome data will be captured prior to randomisation, and at 4 (after PES), 8 (after EMDR) and 14 months postrandomisation by masked assessors. 144 adults with intellectual disabilities with a diagnosis of PTSD will be allocated (1:1) randomly using minimisation from National Health Service (NHS) community and inpatients services for adults with intellectual disabilities in England. Participants are eligible to take part in this trial if: (1) they are aged 18 or older, but younger than 66, (2) have a Full Scale IQ<75, (3) meet diagnostic criteria for PTSD and (4) have suffered a major identified trauma at least a year earlier and (5) are able to communicate using English and have capacity to consent to take part in this clinical trial. Participants allocated to the active intervention will receive 10 sessions of PES, followed by up to 15 sessions of EMDR alongside TAU. The active intervention is being delivered by psychologists experienced in working with adults with intellectual disabilities who have received additional intervention training. TAU is likely to include medication, behaviour support plans designed to target challenging behaviour, or non-trauma-focused psychological interventions. The primary outcome is a measure of PTSD symptoms. Secondary outcomes are other mental health problems, including anxiety and depression, challenging behaviour, participant and carer QoL, and carer burden. We are also capturing cost data to allow for a cost–utility analysis. A process evaluation will be completed using data generated from semistructured interviews with a sample of participants, therapists and carers alongside the capture of fidelity and adherence data.AnalysisThe primary outcome will be assessed using an intention-to-treat analysis. Baseline characteristics will be compared between arms to determine whether any potentially influential imbalance occurred. The primary outcome will be analysed by analysis of covariance, adjusting for baseline values of the outcome and any variables used in the randomisation process. Secondary outcomes will be analysed using linear or logistic regression models as appropriate reflecting the distribution of the outcome variable. The treatment effect will be estimated as an adjusted difference between sample means, presented with 95% CIs and p values. A complier average causal effect analysis will be considered should the data availability be sufficient to estimate the impact of non-compliance. A series of subgroup analyses on the primary outcomes will be considered considering differences in the Impact of Event Scale–Intellectual Disabilities scores at 14 months for (1) differing levels of general intellectual functioning and (2) PTSD versus complex PTSD.Ethics and disseminationThis clinical trial was designed to allow for conclusions about whether PES/EMDR+TAU is efficacious in reducing symptoms of PTSD, relative to TAU, for adults with intellectual disabilities. A favourable ethical opinion has been received from an NHS ethics committee in the UK. The findings from this trial will be published within peer-reviewed journals and shared at national and international conferences. We will also aim to record and distribute podcasts detailing our findings together with our partners.Trial registration numberISRCTN35167485.

Previous studies have shown that cognitive behavioral therapy (CBT) is beneficial for enhancing blood sugar monitoring and mental health in diabetic patients, but no studies have compared all CBT formats to determine which one is more effective. This review compared different delivery formats for CBT for diabetes. We searched nine databases for randomized clinical trials comparing one CBT delivery format against another format or control conditions for patients with diabetes. The primary outcomes were glycated hemoglobin (HbA1c) reduction, severity of depression and anxiety. Pairwise and network meta-analyses were used to synthesize the data. 29 trials with 5,208 participants were included. Network meta-analyses showed at post-intervention, with very low to moderate evidence, digital assisted was probably the most effective in decreasing depression compared with unguided and guided self-help, individual, group, treatment as usual (TAU), education, waitlist plus TAU and waitlist. At follow-up, moderate evidence indicated digital assisted significantly reduced depression and anxiety compared to group, education, TAU, and waitlist, and outperformed individual and waitlist plus TAU for depression. Evidence from very low to low indicated other CBT formats also showed improvement in relevant outcomes. MD range for glycated hemoglobin (follow-up): -1.24 to -0.45%; MD range for depression (post-intervention): -35.08 to -8.21; MD range for depression (follow-up): -54.00 to 5.89; SMD range for anxiety: -17.51 to -0.74; SMD range for quality of life: 2.12 to 3.39. Digital-assisted CBT appears most effective for reducing depression and anxiety, while group and guided self-help formats showed benefits for HbA1c and distress. Limitations include potential publication bias on group CBT format for HbA1c and distress, lack of anxiety outcomes and digital assisted format studies. PROSPERO (CRD42024515804).