Clinical trial NCT00546221: Promoting Wellbeing for Women With Depression: A Pragmatic Randomised Controlled Trial (RCT) of an Exercise Programme
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: Depression
Mental health
Exercise
Prescribed exercise
Physical health
Social wellbeing
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Burdett Trust for Nursing
name: Nottinghamshire Healthcare NHS Trust
name: Nottingham City Primary Care Trust
name: Nottinghamshire County Teaching Primary Care Trust
First posted: 2007-10-18
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2).
timeFrame: At the plenary session of the programmes.
Secondary outcomes:
measure: Resting heart rate.
timeFrame: At the plenary session of the programmes.
measure: GHQ12.
timeFrame: At the plenary session of the programmes.
measure: The SF-12vII.
timeFrame: At the plenary session of the programmes.
measure: The Rosenberg self-esteem scale.
timeFrame: At the plenary session of the programmes.
measure: Quality of life in depression scale.
timeFrame: At the plenary session of the programmes.
measure: The multidimensional scale of perceived social support.
timeFrame: At the plenary session of the programmes.
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham City Primary Care Trust
state: Nottinghamshire
city: Nottingham
country: United Kingdom
facility: Nottinghamshire County Teaching Primary Care Trust
state: Nottinghamshire
city: Nottingham
country: United Kingdom
facility: Nottinghamshire Healthcare NHS Trust
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Patrick Callaghan, RN BSc MSc PhD CPsychol
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Elizabeth B Khalil, BSc MSc PhD (Cant.)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.