Exercise Recovery From Persistent Depression: A Thematic Analysis

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05539495
• Other study ID #: 22032
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: August 2023

Study information

• Verified date: September 2022
• Source: University of Nottingham
• Contact: Neil Nixon, BSc,MMedSci,MBBS,DM,FRCPsych
• Phone: 000
• Email: neil.nixon[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression Moderate
• Depression Severe
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
United Kingdom	Nottinghamshire Healthcare NHS Foundation Trust	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Nottinghamshire Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (21)

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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. — View Citation

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.

Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006 Jan;3(2):77-101.

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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. — View Citation

GAD7 Anxiety Test Questionnaire | Patient [Internet]. [cited 2022 May 9]. Available from: https://patient.info/doctor/generalised-anxiety-disorder-assessment-gad-7

HRA N. Seeking Consent in COVID-19 Research. 2020.

Knapen J, Vancampfort D, Moriën 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. Review. — View Citation

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;

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. — View Citation

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. — View Citation

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-

Online surveys [Internet]. [cited 2022 May 9]. Available from: https://www.onlinesurveys.ac.uk/

PHQ-9 Depression Test Questionnaire | Patient [Internet]. [cited 2022 May 9]. Available from: https://patient.info/doctor/patient-health-questionnaire-phq-9

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	What are the barriers and drivers to using exercise as a treatment for persistent major depression? via thematic analysis of semi-structured interview.	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	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.	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	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.	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