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

Katrin Hulme, Joanna L Hudson, Federica Picariello, Natasha Seaton, Sam Norton, Abigail Wroe, Rona Moss-Morris, Katrin Hulme, Joanna L Hudson, Federica Picariello, Natasha Seaton, Sam Norton, Abigail Wroe, Rona Moss-Morris

Abstract

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.

Keywords: anxiety disorders; clinical trials; depression & mood disorders.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Radar plot of PRECIS-2 factors to determine the type of approach taken, rated from 1 (very explanatory) to 5 (very pragmatic).
Figure 2
Figure 2
CONSORT diagram indicating study recruitment, eligibility screening and follow-up. CONSORT, Consolidated Standards of Reporting Trials; LTC, long-term physical health condition; SCS, standard charity support.

References

    1. Naylor C, Parsonage M, McDaid D, et al. . Long-Term conditions and mental health: the cost of co-morbidities, 2012. Available:
    1. Hutter N, Schnurr A, Baumeister H. Healthcare costs in patients with diabetes mellitus and comorbid mental disorders--a systematic review. Diabetologia 2010;53:2470–9. 10.1007/s00125-010-1873-y
    1. Naylor C, Das P, Ross S, et al. . Bringing together physical and mental health. King’s Fund, 2016. Available:
    1. Wakefield S, Kellett S, Simmonds-Buckley M, et al. . Improving access to psychological therapies (IAPT) in the United Kingdom: a systematic review and meta-analysis of 10-years of practice-based evidence. Br J Clin Psychol 2021;60:1–37. 10.1111/bjc.12259
    1. Catarino A, Bateup S, Tablan V, et al. . Demographic and clinical predictors of response to internet-enabled cognitive-behavioural therapy for depression and anxiety. BJPsych Open 2018;4:411–8. 10.1192/bjo.2018.57
    1. De Lusignan S, Jones S, McCrae N. IAPT LTC/MUS Pathfinder evaluation project. Surrey, UK: University of Surrey, 2016.
    1. Nobis S, Lehr D, Ebert DD, et al. . Efficacy of a web-based intervention with mobile phone support in treating depressive symptoms in adults with type 1 and type 2 diabetes: a randomized controlled trial. Diabetes Care 2015;38:776–83. 10.2337/dc14-1728
    1. Moussavi S, Chatterji S, Verdes E, et al. . Depression, chronic diseases, and decrements in health: results from the world health surveys. Lancet 2007;370:851–8. 10.1016/S0140-6736(07)61415-9
    1. Hudson JL, Moss-Morris R. Treating illness distress in chronic illness. Eur Psychol 2019;24:26–37. 10.1027/1016-9040/a000352
    1. Moss-Morris R. Adjusting to chronic illness: time for a unified theory. Br J Health Psychol 2013;18:681–6. 10.1111/bjhp.12072
    1. Murray E, Hekler EB, Andersson G, et al. . Evaluating digital health interventions: key questions and approaches. Am J Prev Med 2016;51:843–51. 10.1016/j.amepre.2016.06.008
    1. May C, Gask L, Atkinson T, et al. . Resisting and promoting new technologies in clinical practice: the case of telepsychiatry. Soc Sci Med 2001;52:1889–901. 10.1016/S0277-9536(00)00305-1
    1. Alvidrez J, Azocar F. Distressed women's clinic patients: preferences for mental health treatments and perceived obstacles. Gen Hosp Psychiatry 1999;21:340–7. 10.1016/s0163-8343(99)00038-9
    1. Hollon SD, Muñoz RF, Barlow DH, et al. . Psychosocial intervention development for the prevention and treatment of depression: promoting innovation and increasing access. Biol Psychiatry 2002;52:610–30. 10.1016/S0006-3223(02)01384-7
    1. Nutting PA, Rost K, Dickinson M, et al. . Barriers to initiating depression treatment in primary care practice. J Gen Intern Med 2002;17:103–11. 10.1046/j.1525-1497.2002.10128.x
    1. Andersson G, Cuijpers P, Carlbring P, et al. . Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry 2014;13:288–95. 10.1002/wps.20151
    1. Karyotaki E, Efthimiou O, Miguel C, et al. . Internet-Based cognitive behavioral therapy for depression: a systematic review and individual patient data network meta-analysis. JAMA Psychiatry 2021;78:361–71. 10.1001/jamapsychiatry.2020.4364
    1. Holmes EA, O'Connor RC, Perry VH, et al. . Multidisciplinary research priorities for the COVID-19 pandemic: a call for action for mental health science. Lancet Psychiatry 2020;7:547–60. 10.1016/S2215-0366(20)30168-1
    1. Kidney Care UK . Worried sick - the impact of COVID-19 on people living with kidney disease: findings from a patient survey, 2020.
    1. Kroenke K, Wu J, Yu Z, et al. . Patient health questionnaire anxiety and depression scale: initial validation in three clinical trials. Psychosom Med 2016;78:716–27. 10.1097/PSY.0000000000000322
    1. Loudon K, Treweek S, Sullivan F, et al. . The PRECIS-2 tool: designing trials that are fit for purpose. BMJ 2015;350:h2147. 10.1136/bmj.h2147
    1. Kroenke K, Spitzer RL, Williams JBW, et al. . An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics 2009;50:613–21. 10.1176/appi.psy.50.6.613
    1. Moher D, Hopewell S, Schulz KF, et al. . Consort 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869. 10.1136/bmj.c869
    1. Richards DA. Clinical Case Management Supervision. In: The Wiley international Handbook of clinical supervision. John Wiley & Sons, Ltd, 2014: 518–29.
    1. French DP, Miles LM, Elbourne D, et al. . Reducing bias in trials from reactions to measurement: the merit study including developmental work and expert workshop. Health Technol Assess 2021;25:1–72. 10.3310/hta25550
    1. National Collaborating Centre for Mental Health . The improving access to psychological therapies (IAPT) pathway for people with long-term physical health conditions and medically unexplained symptoms: full implementation guidance. London: NICE, 2018.
    1. Everitt H, Landau S, Little P, et al. . Assessing cognitive behavioural therapy in irritable bowel (ACTIB): protocol for a randomised controlled trial of clinical-effectiveness and cost-effectiveness of therapist delivered cognitive behavioural therapy and web-based self-management in irritable bowel syndrome in adults. BMJ Open 2015;5:e008622. 10.1136/bmjopen-2015-008622
    1. Everitt HA, Landau S, O'Reilly G, et al. . Assessing telephone-delivered cognitive-behavioural therapy (CBT) and web-delivered CBT versus treatment as usual in irritable bowel syndrome (ACTIB): a multicentre randomised trial. Gut 2019;68:1613. 10.1136/gutjnl-2018-317805
    1. Kroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity measure. Psychiatr Ann 2002;32:509–15. 10.3928/0048-5713-20020901-06
    1. Spitzer RL, Kroenke K, Williams JBW, et al. . A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006;166:1092–7. 10.1001/archinte.166.10.1092
    1. Mundt JC, Marks IM, Shear MK, et al. . The work and social adjustment scale: a simple measure of impairment in functioning. Br J Psychiatry 2002;180:461–4. 10.1192/bjp.180.5.461
    1. Moss-Morris R, Weinman J, Petrie K, et al. . The revised illness perception questionnaire (IPQ-R). Psychol Health 2002;17:1–16. 10.1080/08870440290001494
    1. Rabin R, de Charro F, Fd C. EQ-5D: a measure of health status from the EuroQol group. Ann Med 2001;33:337–43. 10.3109/07853890109002087
    1. Hibbard JH, Mahoney ER, Stockard J, et al. . Development and testing of a short form of the patient activation measure. Health Serv Res 2005;40:1918–30. 10.1111/j.1475-6773.2005.00438.x
    1. Guy W. Clinical global impression scale. The ECDEU assessment manual for psychopharmacology. Rockville, MD: National Institute of Mental Health, 1976: 218–22.
    1. Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 2003;189:98–101. 10.1067/mob.2003.379
    1. Mc Sharry J, Bishop FL, Moss-Morris R, et al. . A new measure of multimorbid illness and treatment representations: the example of diabetes and depression. J Affect Disord 2015;174:192–200. 10.1016/j.jad.2014.11.050
    1. Thornicroft G. An adapted version of the Client Service Receipt Inventory. In: Beecham J, Knapp M, eds. Costing psychiatric interventions. London: Measuring Mental Health Needs, 2001.
    1. National Collaborating Centre for Mental Health . Depression in adults with a chronic physical health problem: treatment and management. London: The British Psychological Society and The Royal College of Psychiatrists, 2010.
    1. Picariello F, Moss-Morris R, Norton S, et al. . Feasibility trial of cognitive behavioral therapy for fatigue in hemodialysis (BReF intervention). J Pain Symptom Manage 2021;61:1234–46. 10.1016/j.jpainsymman.2020.10.005
    1. Scott W, Guildford BJ, Badenoch J, et al. . Feasibility randomized-controlled trial of online acceptance and commitment therapy for painful peripheral neuropathy in people living with HIV: the open study. Eur J Pain 2021;25:1493–507. 10.1002/ejp.1762
    1. Hudson JL, Moss-Morris R, Norton S, et al. . Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: a feasibility randomised controlled trial. J Psychosom Res 2017;102:61–70. 10.1016/j.jpsychores.2017.09.009
    1. Bogosian A, Hughes A, Norton S, et al. . Potential treatment mechanisms in a mindfulness-based intervention for people with progressive multiple sclerosis. Br J Health Psychol 2016;21:859–80. 10.1111/bjhp.12201
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3:77–101. 10.1191/1478088706qp063oa
    1. Ioannidis JPA, Evans SJW, Gøtzsche PC, et al. . Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781–8. 10.7326/0003-4819-141-10-200411160-00009
    1. Duggan C, Parry G, McMurran M, et al. . The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials. Trials 2014;15:1–9. 10.1186/1745-6215-15-335
    1. Clark D, Oates M. Improving access to psychological therapies: measuring improvement and recovery adult services. London: NHS England, 2014.
    1. O'Cathain A, Croot L, Duncan E, et al. . Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open 2019;9:e029954. 10.1136/bmjopen-2019-029954
    1. Yardley L, Morrison L, Bradbury K, et al. . The person-based approach to intervention development: application to digital health-related behavior change interventions. J Med Internet Res 2015;17:e30. 10.2196/jmir.4055

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera