- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05539495
Exercise Recovery From Persistent Depression: A Thematic Analysis
September 13, 2022 updated by: University of Nottingham
Exercise Recovery From Persistent Major Depression in a UK Tertiary Care Centre: A Qualitative Thematic Analysis of Barriers and Drivers to Participation in a Structured Group Exercise Program
Depression is a leading cause of disability worldwide and poses a large economic burden in the UK.
There is evidence that exercise is beneficial in the management of depression and NICE now recommends group exercise programs as a treatment for people with mild and moderate-severe depression.
Research shows that patients with severe depression are less likely to engage in exercise than patients with mild to moderate depression.
There is little evidence, however, on the barriers and drivers to participation in such programs experienced by patients with depression; leading to uncertainty in the most effective way to implement these programs.
We aim to analyse accounts of patients who have been referred to or participated in the Exercise Recovery Group (ERG), a group exercise program at the Nottingham Specialist Depression Service (NSDS).
The NSDS is a tertiary unit where referred patients have suffered moderate-severe, persistent clinical depression.
Eligible participants will be patients with persistent major depression who have agreed to referral to the ERG at the NSDS and who are able to provide informed consent.
Participants will undergo a one-off 60 minute meeting via MS Teams, including an in-depth semi-structured interview on their experience as well as self-completion questionnaires assessing demographics, depression, anxiety and shame.
Transcripts of the interviews will be subject to qualitative thematic analysis addressing questions on barriers and drivers of exercise treatment in depression; and the perceived impact of an exercise group on the individual participating.
Themes will be developed to give an account of these questions, supported by anonymised quotes from the transcripts.
The questionnaire data (on demographics, depression, anxiety, shame) will be used to characterise the group, in order to help assess directness of the evidence provided for other clinical populations; ultimately helping clinicians to implement exercise groups for depression that are acceptable for patients.
Study Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Neil Nixon, BSc,MMedSci,MBBS,DM,FRCPsych
- Phone Number: 000
- Email: neil.nixon@nottingham.ac.uk
Study Locations
-
-
Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG3 6AA
- Nottinghamshire Healthcare NHS Foundation Trust
-
Contact:
- Mark Howells
- Phone Number: 10155 0115 969 1300
- Email: research@nottshc.nhs.uk
-
Sub-Investigator:
- Lara Nassar, BSc, BMBS
-
Sub-Investigator:
- Elena Nixon, MA (hons), PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with persistent major depression who have at least agreed to referral to the Exercise Recovery Group at the Nottingham Specialist Depression Service within the previous 24 months
Description
Inclusion Criteria:
- Patients with persistent major depression
- Patients who have at least agreed to referral to the Exercise Recovery Group within the previous 24 months
- Patients who are able to provide informed consent.
Exclusion Criteria:
- Patients with a main diagnosis of Bipolar Disorder.
- Patients who cannot speak fluently in English.
- Patients without an email account or access to an electronic device that could be used for the MS Teams meeting.
- Patients who are younger than 18-years-old. There is no upper age limit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
What are the barriers and drivers to using exercise as a treatment for persistent major depression? via thematic analysis of semi-structured interview.
Time Frame: 12 months
|
Semi-structured interview transcripts will be subject to a qualitative thematic analysis with simple descriptive statistics (via demographic questionnaire, PHQ9, GAD7, and ESS) to characterise the sample and support any anonymised quotes.
Analysis of interviews will use a standard Qualitative software package (NVivo version 12) to conduct thematic analysis through an iterative process of coding, organising coding into themes, reviewing themes, and generating a final thematic narrative with reference to the research question.
We will use both deductive and inductive elements in the thematic analysis.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
How do these barriers and drivers operate at different stages of 'participation', including contemplation of group participation; and within group participation? via thematic analysis of semi-structured interview.
Time Frame: 12 months
|
Semi-structured interview transcripts will be subject to a qualitative thematic analysis with simple descriptive statistics (via demographic questionnaire, PHQ9, GAD7, and ESS) to characterise the sample and support any anonymised quotes.
Analysis of interviews will use a standard Qualitative software package (NVivo version 12) to conduct thematic analysis through an iterative process of coding, organising coding into themes, reviewing themes, and generating a final thematic narrative with reference to the research question.
We will use both deductive and inductive elements in the thematic analysis.
|
12 months
|
What is the perceived impact of an exercise group on the individual participating, including positive and negative effects? via thematic analysis of semi-structured interview.
Time Frame: 12 months
|
Semi-structured interview transcripts will be subject to a qualitative thematic analysis with simple descriptive statistics (via demographic questionnaire, PHQ9, GAD7, and ESS) to characterise the sample and support any anonymised quotes.
Analysis of interviews will use a standard Qualitative software package (NVivo version 12) to conduct thematic analysis through an iterative process of coding, organising coding into themes, reviewing themes, and generating a final thematic narrative with reference to the research question.
We will use both deductive and inductive elements in the thematic analysis.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Neil Nixon, BSc,MMedSci,MBBS,DM,FRCPsych, University of Nottingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Braun V, Clarke V. To saturate or not to saturate? Questioning data saturation as a useful concept for thematic analysis and sample-size rationales. https://doi.org/101080/2159676X20191704846 [Internet]. 2019 [cited 2022 Apr 28];13(2):201-16.
- Depression [Internet]. [cited 2022 Apr 17].
- Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Prefer Adherence. 2012;6:369-88. doi: 10.2147/PPA.S29716. Epub 2012 May 1.
- Coronavirus and depression in adults, Great Britain - Office for National Statistics [Internet]. [cited 2022 Apr 17].
- Mcdaid D, Park A-L, Davidson G, John A, Knifton L, Morton A, et al. Mental Health Foundation Shari McDaid, Mental Health Foundation, Mental Health Foundation Naomi Wilson. Ment Heal Found. 2022;
- Knapen J, Vancampfort D, Morien Y, Marchal Y. Exercise therapy improves both mental and physical health in patients with major depression. Disabil Rehabil. 2015;37(16):1490-5. doi: 10.3109/09638288.2014.972579. Epub 2014 Oct 24.
- Doose M, Ziegenbein M, Hoos O, Reim D, Stengert W, Hoffer N, Vogel C, Ziert Y, Sieberer M. Self-selected intensity exercise in the treatment of major depression: A pragmatic RCT. Int J Psychiatry Clin Pract. 2015;19(4):266-75. doi: 10.3109/13651501.2015.1082599. Epub 2015 Sep 23.
- Schuch FB, Vasconcelos-Moreno MP, Borowsky C, Zimmermann AB, Rocha NS, Fleck MP. Exercise and severe major depression: effect on symptom severity and quality of life at discharge in an inpatient cohort. J Psychiatr Res. 2015 Feb;61:25-32. doi: 10.1016/j.jpsychires.2014.11.005. Epub 2014 Nov 21.
- Schuch FB, Stubbs B. The Role of Exercise in Preventing and Treating Depression. Curr Sports Med Rep. 2019 Aug;18(8):299-304. doi: 10.1249/JSR.0000000000000620.
- Schuch FB, Vancampfort D, Rosenbaum S, Richards J, Ward PB, Stubbs B. Exercise improves physical and psychological quality of life in people with depression: A meta-analysis including the evaluation of control group response. Psychiatry Res. 2016 Jul 30;241:47-54. doi: 10.1016/j.psychres.2016.04.054. Epub 2016 Apr 26.
- Xie Y, Wu Z, Sun L, Zhou L, Wang G, Xiao L, Wang H. The Effects and Mechanisms of Exercise on the Treatment of Depression. Front Psychiatry. 2021 Nov 5;12:705559. doi: 10.3389/fpsyt.2021.705559. eCollection 2021.
- NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Guideline Depression in adults Draft for consultation, November 2021 [Internet]. [cited 2022 May 9]. Available from: https://www.nice.org.uk/guidance/GID-
- Monteiro FC, Schuch FB, Deslandes AC, Mosqueiro BP, Caldieraro MA, Fleck MPA. Factors associated with adherence to sports and exercise among outpatients with major depressive disorder. Trends Psychiatry Psychother. 2021 Apr-Jun;43(2):108-115. doi: 10.47626/2237-6089-2019-0109. Epub 2021 Jun 15.
- Stanton R, Reaburn P. Exercise and the treatment of depression: a review of the exercise program variables. J Sci Med Sport. 2014 Mar;17(2):177-82. doi: 10.1016/j.jsams.2013.03.010. Epub 2013 Apr 18.
- Morriss R, Garland A, Nixon N, Guo B, James M, Kaylor-Hughes C, Moore R, Ramana R, Sampson C, Sweeney T, Dalgleish T; NIHR CLAHRC Specialist Mood Disorder Study Group. Efficacy and cost-effectiveness of a specialist depression service versus usual specialist mental health care to manage persistent depression: a randomised controlled trial. Lancet Psychiatry. 2016 Sep;3(9):821-31. doi: 10.1016/S2215-0366(16)30143-2. Epub 2016 Aug 3.
- Online surveys [Internet]. [cited 2022 May 9]. Available from: https://www.onlinesurveys.ac.uk/
- HRA N. Seeking Consent in COVID-19 Research. 2020.
- PHQ-9 Depression Test Questionnaire | Patient [Internet]. [cited 2022 May 9]. Available from: https://patient.info/doctor/patient-health-questionnaire-phq-9
- GAD7 Anxiety Test Questionnaire | Patient [Internet]. [cited 2022 May 9]. Available from: https://patient.info/doctor/generalised-anxiety-disorder-assessment-gad-7
- Andrews B, Qian M, Valentine JD. Predicting depressive symptoms with a new measure of shame: The Experience of Shame Scale. Br J Clin Psychol. 2002 Mar;41(Pt 1):29-42. doi: 10.1348/014466502163778.
- Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006 Jan;3(2):77-101.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2022
Primary Completion (ANTICIPATED)
December 1, 2022
Study Completion (ANTICIPATED)
August 1, 2023
Study Registration Dates
First Submitted
September 5, 2022
First Submitted That Met QC Criteria
September 13, 2022
First Posted (ACTUAL)
September 14, 2022
Study Record Updates
Last Update Posted (ACTUAL)
September 14, 2022
Last Update Submitted That Met QC Criteria
September 13, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22032
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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