Promoting Wellbeing for Women With Depression: A Pragmatic Randomised Controlled Trial (RCT) of an Exercise Programme

Study Overview
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Brief Summary
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The investigators want to find out if their specially designed exercise programme will be more successful at helping women with depression to feel better than a basic programme will, by measuring the effect the programme has on mood, physical health, and social wellbeing. Their specially designed exercise programme will involve physical exertion at the participants' chosen level of intensity (how hard the body has to work during exercise), and will include motivational support. By contrast, the basic exercise programme will be at an intensity recommended by national guidelines, of the type that may be prescribed by a general practitioner (GP), and will include no extra motivational support.

Official Title
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Pragmatic Randomised Controlled Trial of a Preferred Intensity Exercise Programme to Improve Physiological and Associated Psychological, Social, and Wellbeing Outcomes of Women Living With Depression

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Psychosocial support exercise programme
* Behavioral: Prescribed exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living with depression Aged 18 (age at first session of programme) Female Living in the community Resident within Nottinghamshire (personal address has Nottinghamshire postcode) Exclusion Criteria: Women who, at the time of the study, are unable to participate on account of any injury or physical health problem that precludes their participation Women participating in research that may undermine the scientific basis of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychosocial support<br>Comprising 22 participants engaging in the experimental exercise programme, exercising with psychosocial support. | Behavioral: Psychosocial support exercise programme<br>* The experimental arm will experience 12 sessions of intervention, at a rate of three sessions a week for four weeks, exercising in groups of ten women. Each session will comprise: fifteen minutes of psychosocial and motivational support, run by a qualified rehabilitation psychologist and overseen by a qualified health psychologist; a half hour preferred intensity exercise session run by a qualified sports physiotherapist. Participants preferred intensity (chosen exertion level) will be established using the Borg RPE scale (Borg G 1998).<br>|
| Active Comparator: Prescribed exercise<br>Comprising 21 participants engaging in a programme of typical prescribed exercise. | Behavioral: Prescribed exercise<br>* This group will experience 12 sessions of intervention, at a rate of three sessions a week for four weeks, exercising in groups of ten women. Each session will be an half hour exercise session, at a typically (GP) prescribed level, designed in accordance with national guidelines and run by a qualified sports physiotherapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2). |  | At the plenary session of the programmes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting heart rate. |  | At the plenary session of the programmes. | 
| GHQ12. |  | At the plenary session of the programmes. | 
| The SF-12vII. |  | At the plenary session of the programmes. | 
| The Rosenberg self-esteem scale. |  | At the plenary session of the programmes. | 
| Quality of life in depression scale. |  | At the plenary session of the programmes. | 
| The multidimensional scale of perceived social support. |  | At the plenary session of the programmes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Mental health, Exercise, Prescribed exercise, Physical health, Social wellbeing