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Completed

NCT Number: NCT00546221

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Motor Activity Personal Satisfaction Psychological Well-Being

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Nottingham City Primary Care Trust, Nottingham, Nottinghamshire, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychosocial support exercise programme

Behavioral

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).

Prescribed exercise

Behavioral

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.

Primary outcomes

  1. The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2).

    Time frame: At the plenary session of the programmes.

Secondary outcomes

  1. Resting heart rate.

    Time frame: At the plenary session of the programmes.

  2. GHQ12.

    Time frame: At the plenary session of the programmes.

  3. The SF-12vII.

    Time frame: At the plenary session of the programmes.

  4. The Rosenberg self-esteem scale.

    Time frame: At the plenary session of the programmes.

  5. Quality of life in depression scale.

    Time frame: At the plenary session of the programmes.

  6. The multidimensional scale of perceived social support.

    Time frame: At the plenary session of the programmes.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Burdett Trust for Nursing
  • Nottingham City Primary Care Trust
  • Nottinghamshire County Teaching Primary Care Trust
  • Nottinghamshire Healthcare NHS Trust

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 18, 2007
Registry last updated
Mar 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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