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

Phase 2

Completed

• Conditions: Depression
• Interventions: Behavioral: Psychosocial support exercise programme; Behavioral: Prescribed exercise

• Registration Number: NCT00546221
• Lead Sponsor: University of Nottingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-17
• Study First Posted: 2007-10-18
• Study Start: 2007-11
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-02
• Last Update Posted: 2011-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychosocial support	Psychosocial support exercise programme	Comprising 22 participants engaging in the experimental exercise programme, exercising with psychosocial support.
Prescribed exercise	Prescribed exercise	Comprising 21 participants engaging in a programme of typical prescribed exercise.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (3)

Nottingham City Primary Care Trust; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom

Nottinghamshire County Teaching Primary Care Trust; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom

Nottinghamshire Healthcare NHS Trust; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom