A randomized controlled trial of a digital cognitive-behavioral therapy program (COMPASS) for managing depression and anxiety related to living with a long-term physical health condition.

BACKGROUND: To evaluate the clinical efficacy of COMPASS, a therapist-supported digital therapeutic for reducing psychological distress (anxiety/depression) in people living with long-term physical health conditions (LTCs). METHODS: A two-armed randomized-controlled trial recruiting from LTC charities. Participants with anxiety and/or depression symptoms related to their LTC(s) were randomized (concealed allocation via independent administrator) to COMPASS (access to 11 tailored modules plus five thirty-minute therapist support sessions) or standard charity support (SCS). Assessments were completed online pre-randomization, at 6- and 12-weeks post-randomization. Primary outcome was Patient Health Questionnaire Anxiety and Depression Scale; PHQ-ADS measured at 12-weeks. Analysis used intention-to-treat principles with adjusted mean differences estimated using linear mixed-effects models. Data-analyst was blinded to group allocation. RESULTS: 194 participants were randomized to COMPASS (N = 94) or SCS (N = 100). At 12-weeks, mean level of psychological distress was 6.82 (95% confidence interval; CI 4.55-9.10) points lower (p < 0.001) in the COMPASS arm compared with SCS (standardized mean difference of 0.71 (95% CI 0.48-0.95)). The COMPASS arm also showed moderate significant treatment effects on secondary outcomes including depression, anxiety and illness-related distress and small significant effects on functioning and quality-of-life. Rates of adverse events were comparable across the arms. Deterioration in distress at 12-weeks was observed in 2.2% of the SCS arm, and no participants in the COMPASS arm. CONCLUSION: Compared with SCS, COMPASS digital therapeutic with minimal therapist input reduces psychological distress at post-treatment (12-weeks). COMPASS offers a potentially scalable implementation model for health services but its translation to these contexts needs further evaluating. TRIAL REGISTRATION: NCT04535778.

Do interventions for mood improve inflammatory biomarkers in inflammatory bowel disease?: a systematic review and meta-analysis.

BACKGROUND: Psychoneuroimmunological mechanisms and the gut-brain axis appear relevant to disease activity and progression in Inflammatory Bowel Disease (IBD). A recent review showed no effect of psychological therapies on self-reported disease activity in IBD. This meta-analysis aims to establish whether interventions targeting mood outcomes (e.g., depression, anxiety and stress) impact inflammation levels in IBD and possible moderators of these effects. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. We searched five electronic databases and included randomised controlled trials where interventions targeted mood and assessed inflammatory outcomes pre- and post-intervention in adults with IBD. Independent reviewers screened studies, extracted data, and assessed methodological quality. Data were pooled to estimate standardised mean differences (SMDs) with 95% Confidence Intervals (CIs). A random-effects robust variance estimation accounted for studies measuring multiple biomarkers. Intervention type, mood as a primary or secondary outcome, effect on mood outcomes and IBD subtype were investigated as treatment effect moderators. Where there were sufficient biomarkers, individual meta-analyses were run (Pre-registration PROSPERO: CRD42023389401). FINDINGS: 28 RCTs involving 1789 participants met inclusion criteria. Interventions demonstrated small, statistically significant effects on biomarkers (-0.35, 95% CI: -0.48, -0.22, p < 0.001) and medium effects on mood outcomes (-0.50, 95% CI: -0.73, -0.27, p < 0.001), without evidence of substantive heterogeneity or publication bias. Individual analyses showed small effects for improved faecal calprotectin (-0.19, 95% CI: -0.34, -0.03, p = 0.018) and C-Reactive Protein (-0.29, 95% CI: -0.47, -0.10, p = 0.002). Effect sizes were larger for psychological therapy interventions (compared with exercise or antidepressants) and when there was an effect (SMD ≥0.2) on mood. INTERPRETATION: Treatments which address mood outcomes have beneficial effects on generic inflammation as well as disease-specific biomarkers (faecal calprotectin and C-Reactive Protein). Psychological interventions and interventions with larger treatment effects on mood accentuated the effect on biomarkers. More research is required to understand the biological or behavioural mechanisms underlying this effect. FUNDING: The Medical Research Council and the National Institute for Health and Care Research (NIHR) Maudsley Biomedical Research Centre.

A real-world longitudinal study implementing digital screening and treatment for distress in inflammatory bowel disease (IBD): The COMPASS-IBD study protocol.

INTRODUCTION: Co-morbid anxiety and depression (distress) in inflammatory bowel disease (IBD) results in poorer outcomes and increased healthcare burden. IBD services require scalable treatment pathways for distress to meet this need. This real-world longitudinal study evaluates the implementation of a new integrated care pathway for distress including: 1) routine mental health screening and 2) therapist-guided, digital CBT tailored to the challenges of living with IBD (compass with adaptations for IBD: COMPASS-IBD) in a UK National Health Service (NHS) large gastroenterology service (∼ 5000 patients). METHODS: We describe a mixed-methods, observational, real-world longitudinal study. Routine mental health screening in the IBD service will identify patients with distress (using pre-defined clinical cut-offs), who will be triaged to determine appropriate treatment pathways (including participation in the COMPASS-IBD study). Participants will receive COMPASS-IBD online for ∼12 weeks (including 6 × 30-min therapist sessions). Key implementation outcomes will assess reach and adoption of the new pathway using aggregate data on uptake of mental health screening, eligibility, and consent rates for COMPASS-IBD, and number of COMPASS-IBD sessions completed. Interviews with patients and healthcare providers will primarily assess acceptability of the new pathway. Potential effectiveness will be assessed using participant questionnaires at pre-intervention, 12-weeks (post-intervention), and 6-month follow-up. The primary effectiveness outcome will be pre-post changes in distress (PHQ-ADS scores). Quantitative data will be summarised using descriptive statistics and qualitative data analysed using reflexive thematic analysis. CONCLUSION: Study findings will inform treatment pathways for co-morbid distress in IBD, and highlight adaptations required to increase future scalability and effectiveness. TRIAL REGISTRATION NUMBER: NCT05330299 (clinicaltrials.gov).

A cognitive-behavioural therapy programme for managing depression and anxiety in long-term physical health conditions: mixed-methods real-world evaluation of the COMPASS programme.

BACKGROUND: Mental health comorbidities are common in physical long-term health conditions. AIMS: We evaluate the effectiveness of COMPASS, a therapist-supported, digital cognitive-behavioural therapy programme specifically designed to treat anxiety/depression in the context of long-term conditions. We also investigate patient experiences of the programme. METHOD: We utilised a mixed-methods, non-randomised design. We analysed pre-post data from 76 patients with long-term conditions who were receiving psychological treatment (COMPASS) via local NHS services, using paired sample t-tests and Cohen's d, with depression, anxiety, distress and functional impairment self-report scales. Qualitative interviews explored patients' experiences of using COMPASS. Twenty-one semi-structured interviews were completed and underwent inductive thematic analysis. RESULTS: Patients who received COMPASS had significantly reduced depression (-2.47, 95% CI -3.7 to -1.3, P < 0.001; Cohen's d = -0.376), anxiety (-2.30, 95% CI -3.6 to -1.2, P < 0.001; Cohen's d = -0.420) and psychological distress (-4.87, 95% CI -7.0 to -2.7, P < 0.001; Cohen's d = -0.422) and significantly improved functional impairment (-3.00, 95% CI -4.8 to -1.2, P ≤ 0.001; Cohen's d = -0.282). Effect sizes were larger when analyses included only patients with clinically significant baseline symptoms: depression (-4.02, 95% CI -5.6 to -2.5, P < 0.001; Cohen's d = -0.701), anxiety (-3.60, 95% CI -5.3 to -1.9, P < 0.001; Cohen's d = -0.739), psychological distress (-5.58, 95% CI -7.9 to -3.2, P < 0.001; Cohen's d = -0.523), functional impairment (-3.28, 95% CI -5.4 to -1.1, P ≤ 0.001; Cohen's d = -0.355). Qualitative analysis yielded two meta-themes: engagement and integration of mental and physical health. CONCLUSIONS: Results suggest that COMPASS is effective in NHS settings, and is acceptable to patients. Content tailored to long-term conditions, therapist support and clear delivery strategies should be prioritised to aid intervention implementation.

Mental health outcomes in patients with a long-term condition: analysis of an Improving Access to Psychological Therapies service.

BACKGROUND: Having a long-term condition (LTC) significantly affects mental health. UK policy requires effective mental health provisions for patients with an LTC, generally provided by Improving Access to Psychological Therapies (IAPT) services. National IAPT data suggest that patients with an LTC typically demonstrate poorer outcomes compared with patients without an LTC. However, exploration of confounding factors and different outcome variables is limited. AIMS: To establish the association of LTC status with demographic and clinical factors, and clinical mental health outcomes. METHOD: Anonymised patient-level data from a London IAPT service during January 2019 to October 2020 were used in this cohort study, to compare differences between LTC and non-LTC groups on sociodemographic and clinical variables. Binary logistic and multiple linear regression models were constructed for binary outcome variables (recovery and reliable improvement) and continuous outcomes (distress and functioning), respectively. RESULTS: Patients with an LTC were more likely to be female; older; from a Black, mixed or other ethnic background; and have greater social deprivation. Across the four clinical outcomes (recovery, reliable improvement, final psychological distress and final functioning), having an LTC significantly predicted poorer outcomes even after controlling for sociodemographic and clinical baseline variables. For three outcome variables, greater social deprivation and being discharged during the COVID-19 pandemic also predicted poorer clinical outcomes. CONCLUSIONS: LTC status has a negative effect on mental health outcomes in IAPT services, independent of associated variables such as severity of baseline mental health symptoms, ethnicity and social deprivation. Effective psychological treatment for patients with an LTC remains an unresolved priority.

Clinical efficacy of COMPASS, a digital cognitive-behavioural therapy programme for treating anxiety and depression in patients with long-term physical health conditions: a protocol for randomised controlled trial.

INTRODUCTION: Approximately 30% of people with long-term physical health conditions (LTCs) experience mental health problems, with negative consequences and costs for individuals and healthcare services. Access to psychological treatment is scarce and, when available, often focuses on treating primary mental health problems rather than illness-related anxiety/depression. The aim of this study is to evaluate the clinical efficacy of a newly developed, therapist-supported, digital cognitive-behavioural treatment (COMPASS) for reducing LTC-related psychological distress (anxiety/depression), compared with standard charity support (SCS). METHODS AND ANALYSIS: A two-arm, parallel-group randomised controlled trial (1:1 ratio) with nested qualitative study will be conducted. Two-hundred adults with LTC-related anxiety and depression will be recruited through national LTC charities. They will be randomly allocated to receive COMPASS or SCS only. An independent administrator will use Qualtrics randomiser for treatment allocation, to ensure allocation concealment. Participants will access treatment from home over 10 weeks. The COMPASS group will have access to the digital programme and six therapist contacts: one welcome message and five fortnightly phone calls. Data will be collected online at baseline, 6 weeks and 12 weeks post-randomisation for primary outcome (Patient Health Questionnaire Anxiety and Depression Scale) and secondary outcomes (anxiety, depression, daily functioning, COVID-19-related distress, illness-related distress, quality of life, knowledge and confidence for illness self-management, symptom severity and improvement). Analyses will be conducted following the intention-to-treat principle by a data analyst blinded to treatment allocation. A purposively sampled group of COMPASS participants and therapists will be interviewed. Interviews will be thematically analysed. ETHICS AND DISSEMINATION: The study is approved by King's College London's Psychiatry, Nursing and Midwifery Research Ethics Subcommittee (reference: LRS-19/20-20347). All participants will provide informed consent to take part if eligible. Findings will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: NCT04535778.