DepressionPhase 2NCT00546221
Promoting Wellbeing for Women With Depression: A Pragmatic Randomised Controlled Trial (RCT) of an Exercise Programme
A Phase 2 study testing Psychosocial support exercise programme and Prescribed exercise in people with Depression, run by University of Nottingham at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Psychosocial support exercise programme and Prescribed exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Nov 2007to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living with depression
- Aged 18 (age at first session of programme)
- Female
- Living in the community
- Resident within Nottinghamshire (personal address has Nottinghamshire postcode)
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Nottingham City Primary Care Trust
Nottingham, Nottinghamshire
Nottinghamshire County Teaching Primary Care Trust
Nottingham, Nottinghamshire
Nottinghamshire Healthcare NHS Trust
Nottingham, Nottinghamshire
About this study
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
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.
- Conditions
- Depression
- Being tested
- Psychosocial support exercise programme, Prescribed exercise
- Keywords
- Depression, Mental health, Exercise, Prescribed exercise, Physical health, Social wellbeing
- Medical subject headings
- Depression, Psychological Well-Being, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial support exercise programmeBehavioural
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 exerciseBehavioural
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 group | Role | What they receive |
|---|---|---|
| Psychosocial support | Experimental | Comprising 22 participants engaging in the experimental exercise programme, exercising with psychosocial support. Receives: Behavioral: Psychosocial support exercise programme |
| Prescribed exercise | Active comparator | Comprising 21 participants engaging in a programme of typical prescribed exercise. Receives: Behavioral: Prescribed exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2).
Measured: At the plenary session of the programmes.
Secondary outcomes (6)
Resting heart rate.
Measured: At the plenary session of the programmes.
GHQ12.
Measured: At the plenary session of the programmes.
The SF-12vII.
Measured: At the plenary session of the programmes.
The Rosenberg self-esteem scale.
Measured: At the plenary session of the programmes.
Quality of life in depression scale.
Measured: At the plenary session of the programmes.
The multidimensional scale of perceived social support.
Measured: At the plenary session of the programmes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Burdett Trust for Nursing, Nottinghamshire Healthcare NHS Trust, Nottingham City Primary Care Trust, Nottinghamshire County Teaching Primary Care Trust
- Investigators
- Patrick Callaghan, RN BSc MSc PhD CPsychol, Principal investigator, University of NottinghamElizabeth B Khalil, BSc MSc PhD (Cant.), Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546221
- Sponsor's protocol ID
- 07105
- Other IDs
- Funder's ID: 293/350, Ethics ref ID: 07/H0401/110
- Status last verified
- Mar 2011
- First submitted
- 17 Oct 2007
- Last updated
- 3 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00546221
- Acronym / sponsor ID
- 07105
- Conditions
- Depression
- Keywords
- Depression, Mental health, Exercise, Prescribed exercise, Physical health, Social wellbeing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Burdett Trust for Nursing, Nottinghamshire Healthcare NHS Trust, Nottingham City Primary Care Trust, Nottinghamshire County Teaching Primary Care Trust
- Study start
- Nov 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 18 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial support | Experimental | Behavioral: Psychosocial support exercise programmeComprising 22 participants engaging in the experimental exercise programme, exercising with psychosocial support. |
| Prescribed exercise | Active comparator | Behavioral: Prescribed exerciseComprising 21 participants engaging in a programme of typical prescribed exercise. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Living with depression
- Aged 18 (age at first session of programme)
- Female
- Living in the community
- Resident within Nottinghamshire (personal address has Nottinghamshire postcode)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial support exercise programmeThe 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). | Behavioural | Psychosocial support |
| Prescribed exerciseThis 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. | Behavioural | Prescribed exercise |
Primary outcome
The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2).
Time frame: At the plenary session of the programmes.
6 secondary outcomes
Resting heart rate.
Time frame: At the plenary session of the programmes.
GHQ12.
Time frame: At the plenary session of the programmes.
The SF-12vII.
Time frame: At the plenary session of the programmes.
The Rosenberg self-esteem scale.
Time frame: At the plenary session of the programmes.
Quality of life in depression scale.
Time frame: At the plenary session of the programmes.
The multidimensional scale of perceived social support.
Time frame: At the plenary session of the programmes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2011.
- Derived from this study: PubMed 21663696Callaghan 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.
- University of Nottingham, School of Nursing Mental Health Research GroupLink provided by the sponsor.
- project websiteLink provided by the sponsor.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Callaghan, RN BSc MSc PhD CPsychol principal investigator
University of Nottingham
Elizabeth B Khalil, BSc MSc PhD (Cant.) principal investigator
University of Nottingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psychosocial support exercise programme and Prescribed exercise in people with Depression, run by University of Nottingham at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2). (time frame: At the plenary session of the programmes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00546221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2011.