NCT05539495

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

September 5, 2022

Last Update Submit

September 13, 2022

Conditions

Keywords

ExerciseBarriersFacilitators

Outcome Measures

Primary Outcomes (1)

  • 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 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.

    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.

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, Nottinghamshire, NG3 6AA, United Kingdom

Location

Related Publications (21)

  • 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.

    BACKGROUND
  • Depression [Internet]. [cited 2022 Apr 17].

    BACKGROUND
  • 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.

    PMID: 22654508BACKGROUND
  • Coronavirus and depression in adults, Great Britain - Office for National Statistics [Internet]. [cited 2022 Apr 17].

    BACKGROUND
  • 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;

    BACKGROUND
  • 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.

    PMID: 25342564BACKGROUND
  • 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.

    PMID: 26265421BACKGROUND
  • 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.

    PMID: 25439084BACKGROUND
  • 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.

    PMID: 31389872BACKGROUND
  • 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.

    PMID: 27155287BACKGROUND
  • 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.

    PMID: 34803752BACKGROUND
  • 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-

    BACKGROUND
  • 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.

    PMID: 34139115BACKGROUND
  • 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.

    PMID: 23602562BACKGROUND
  • 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.

    PMID: 27498098BACKGROUND
  • Online surveys [Internet]. [cited 2022 May 9]. Available from: https://www.onlinesurveys.ac.uk/

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

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

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

    BACKGROUND
  • 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.

    PMID: 11931676BACKGROUND
  • Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006 Jan;3(2):77-101.

    BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorMotor Activity

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavior

Study Officials

  • Neil Nixon, BSc,MMedSci,MBBS,DM,FRCPsych

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Nixon, BSc,MMedSci,MBBS,DM,FRCPsych

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 14, 2022

Study Start

September 1, 2022

Primary Completion

December 1, 2022

Study Completion

August 1, 2023

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations