Major Depressive DisorderNCT05539495
Exercise Recovery From Persistent Depression: A Thematic Analysis
An observational study of Major Depressive Disorder and Depression Moderate, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Depression Moderate, Depression Severe
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2022to 9 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, Nottinghamshire, NG3 6AA
About this study
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
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.
- Keywords
- Exercise, Barriers, Facilitators
- Medical subject headings
- Depressive Disorder, Major, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 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.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Dec 2022
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottinghamshire Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Neil Nixon, BSc,MMedSci,MBBS,DM,FRCPsych, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539495
- Sponsor's protocol ID
- 22032
- Status last verified
- Jul 2025
- First submitted
- 5 Sep 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 22654508Coronavirus 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.
PubMed 25342564Doose 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.
PubMed 26265421Schuch 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.
PubMed 25439084Schuch 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.
PubMed 31389872Schuch 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.
PubMed 27155287Xie 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.
PubMed 34803752NATIONAL 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.
PubMed 34139115Stanton 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.
PubMed 23602562Morriss 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.
PubMed 27498098
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05539495
- Acronym / sponsor ID
- 22032
- Keywords
- Exercise, Barriers, Facilitators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottinghamshire Healthcare NHS Trust
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- BackgroundBraun 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.
- BackgroundDepression [Internet]. [cited 2022 Apr 17].
- Background: PubMed 22654508Al-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.
- BackgroundCoronavirus and depression in adults, Great Britain - Office for National Statistics [Internet]. [cited 2022 Apr 17].
- BackgroundMcdaid 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;
- Background: PubMed 25342564Knapen 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.
- Background: PubMed 26265421Doose 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.
- Background: PubMed 25439084Schuch 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.
- Background: PubMed 31389872Schuch 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.
- Background: PubMed 27155287Schuch 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.
- Background: PubMed 34803752Xie 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.
- BackgroundNATIONAL 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-
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Nixon, BSc,MMedSci,MBBS,DM,FRCPsych principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Depression Moderate, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05539495, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.