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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 prima...

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Autores principales: Hulme, Katrin, Hudson, Joanna L, Picariello, Federica, Seaton, Natasha, Norton, Sam, Wroe, Abigail, Moss-Morris, Rona
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8557248/
https://www.ncbi.nlm.nih.gov/pubmed/34697123
http://dx.doi.org/10.1136/bmjopen-2021-053971
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author Hulme, Katrin
Hudson, Joanna L
Picariello, Federica
Seaton, Natasha
Norton, Sam
Wroe, Abigail
Moss-Morris, Rona
author_facet Hulme, Katrin
Hudson, Joanna L
Picariello, Federica
Seaton, Natasha
Norton, Sam
Wroe, Abigail
Moss-Morris, Rona
author_sort Hulme, Katrin
collection PubMed
description 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.
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spelling pubmed-85572482021-11-02 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 Hulme, Katrin Hudson, Joanna L Picariello, Federica Seaton, Natasha Norton, Sam Wroe, Abigail Moss-Morris, Rona BMJ Open Mental Health 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. BMJ Publishing Group 2021-10-25 /pmc/articles/PMC8557248/ /pubmed/34697123 http://dx.doi.org/10.1136/bmjopen-2021-053971 Text en © 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. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Mental Health
Hulme, Katrin
Hudson, Joanna L
Picariello, Federica
Seaton, Natasha
Norton, Sam
Wroe, Abigail
Moss-Morris, Rona
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Mental Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8557248/
https://www.ncbi.nlm.nih.gov/pubmed/34697123
http://dx.doi.org/10.1136/bmjopen-2021-053971
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