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

U

University of Nottingham

Status and phase

Completed
Phase 2

Conditions

Depression

Treatments

Behavioral: Psychosocial support exercise programme
Behavioral: Prescribed exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT00546221
07105
Funder's ID: 293/350
Ethics ref ID: 07/H0401/110

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

43 participants in 2 patient groups

Psychosocial support
Experimental group
Description:
Comprising 22 participants engaging in the experimental exercise programme, exercising with psychosocial support.
Treatment:
Behavioral: Psychosocial support exercise programme
Prescribed exercise
Active Comparator group
Description:
Comprising 21 participants engaging in a programme of typical prescribed exercise.
Treatment:
Behavioral: Prescribed exercise

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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