CClinicalTrials.gg
CompletedNCT00546221Updated Mar 3, 2011

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

A Phase 2 interventional study of Psychosocial support exercise programme and Prescribed exercise in Depression, sponsored by University of Nottingham. Completed at 3 sites in United Kingdom. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-03-03.

Sponsored by University of Nottingham · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Depression

Keywords

  • Depression
  • Mental health
  • Exercise
  • Prescribed exercise
  • Physical health
  • Social wellbeing
03

In context

Depression

8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 43 is below the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Psychosocial support

    Comprising 22 participants engaging in the experimental exercise programme, exercising with psychosocial support.

    Behavioral: Psychosocial support exercise programme

  • Active comparator
    Prescribed exercise

    Comprising 21 participants engaging in a programme of typical prescribed exercise.

    Behavioral: Prescribed exercise

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.

06

What researchers measure

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.

07

Study locations

3 sites
  • 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
08

References and documents

Publications

  • Callaghan P, Khalil E, Morres I, Carter T. Pragmatic randomised controlled trial of preferred intensity exercise in women living with depression. BMC Public Health. 2011 Jun 12;11:465. doi: 10.1186/1471-2458-11-465. PubMed 21663696 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00546221
Lead sponsor
University of Nottingham
Collaborators
Burdett Trust for Nursing, Nottinghamshire Healthcare NHS Trust, Nottingham City Primary Care Trust, Nottinghamshire County Teaching Primary Care Trust
First posted
Oct 18, 2007
Start date
Nov 2007
Primary completion
May 2009
Completion
May 2009
Last update
Mar 3, 2011

Study contacts

Patrick Callaghan, RN BSc MSc PhD CPsychol
principal investigator · University of Nottingham
Elizabeth B Khalil, BSc MSc PhD (Cant.)
principal investigator · University of Nottingham

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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