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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00546221

Enrollment

Registered

2007-10-18

Start date

2007-11-30

Completion date

2009-05-31

Last updated

2011-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, Mental health, Exercise, Prescribed exercise, Physical health, Social wellbeing

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.

Interventions

BEHAVIORALPsychosocial support exercise programme

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).

BEHAVIORALPrescribed exercise

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
GHQ12.	At the plenary session of the programmes.
The SF-12vII.	At the plenary session of the programmes.
Resting heart rate.	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.
The Rosenberg self-esteem scale.	At the plenary session of the programmes.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026