DepressionEarly Phase 1BackonTrackNCT00663078
Group Cognitive Behavioral Therapy (CBT) Intervention for Women With Mild to Moderate Depression
A Early Phase 1 study testing Brief CBT Group therapy in people with Depression and Anxiety, run by University of Bristol at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to develop a structured CBT group intervention for women with depression of mild or moderate severity and to pilot a randomized controlled trial to compare this intervention with usual care in socially deprived areas in Bristol, incorporating qualitative methods to assess acceptability. Read more about this study
- Who is it for?
- Ages 30 to 54 years, women only
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Brief CBT Group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2007to Mar 2009
- Phase
- Early Phase 1
- 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 30 to 54 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- mild to moderate depression
- antidepressant use is also OK
Who cannot join
- able to speak english
- abusing drugs or alcohol
- using secondary mental health services
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Merrywood GP Practice Knowle West,
Bristol, bristol, BS
Wellspring Healthy Living Centre
Bristol, Bristol
About this study
Official title: A Pilot Study to Develop a Brief Group Intervention for Women With Mild and Moderate Depression
The purpose of this study is to develop a structured CBT group intervention for women with depression of mild or moderate severity and to pilot a randomized controlled trial to compare this intervention with usual care in socially deprived areas in Bristol, incorporating qualitative methods to assess acceptability.
- Conditions
- Depression, Anxiety
- Being tested
- Brief CBT Group therapy
- Keywords
- Cognitive Behavioral Therapy, expert patient programme, deprived population, women
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief CBT Group therapyBehavioural
CBT based therapy also expert patient programme
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Group A: Women from GP practices and area of Knowle West, Bristol Receives: Behavioral: Brief CBT Group therapy |
| B | Experimental | Group B: Women from Wellspring, GP practice or geographical area of Barton Hill Bristol. Receives: Behavioral: Brief CBT Group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-9 Score
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startAug 2007
- Primary completionMar 2009
- Study completionMar 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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bristol
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663078
- Sponsor's protocol ID
- 07/H0107/60
- Acronym
- BackonTrack
- Status last verified
- Feb 2009
- First submitted
- 18 Apr 2008
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Cramer H, Salisbury C, Conrad J, Eldred J, Araya R. Group cognitive behavioural therapy for women with depression: pilot and feasibility study for a randomised controlled trial using mixed methods. BMC Psychiatry. 2011 May 13;11:82. doi: 10.1186/1471-244X-11-82.
PubMed 21569488
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Develop a Brief Group Intervention for Women With Mild and Moderate Depression
- ClinicalTrials.gov ID
- NCT00663078
- Acronym / sponsor ID
- BackonTrack / 07/H0107/60
- Conditions
- Depression, Anxiety
- Keywords
- Cognitive Behavioral Therapy, expert patient programme, deprived population, women
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of BristolUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Apr 2008 (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 purpose of this study is to develop a structured CBT group intervention for women with depression of mild or moderate severity and to pilot a randomized controlled trial to compare this intervention with usual care in socially deprived areas in Bristol, incorporating qualitative methods to assess acceptability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Brief CBT Group therapyGroup A: Women from GP practices and area of Knowle West, Bristol |
| B | Experimental | Behavioral: Brief CBT Group therapyGroup B: Women from Wellspring, GP practice or geographical area of Barton Hill Bristol. |
Who may qualify
- Ages
- 30 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- mild to moderate depression
- antidepressant use is also OK
Key exclusion criteria (3 listed)
- able to speak english
- abusing drugs or alcohol
- using secondary mental health services
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 |
|---|---|---|
| Brief CBT Group therapyCBT based therapy also expert patient programme | Behavioural | A, B |
Primary outcome
PHQ-9 Score
Time frame: 3 months and 6 months
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 14 Jan 2010.
- Derived from this study: PubMed 21569488Cramer H, Salisbury C, Conrad J, Eldred J, Araya R. Group cognitive behavioural therapy for women with depression: pilot and feasibility study for a randomised controlled trial using mixed methods. BMC Psychiatry. 2011 May 13;11:82. doi: 10.1186/1471-244X-11-82.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Brief CBT Group therapy in people with Depression and Anxiety, run by University of Bristol at 2 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 2 inclusion and 3 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 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
PHQ-9 Score (time frame: 3 months and 6 months). 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 NCT00663078, 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 14 Jan 2010.