Depressive SymptomsCBT-WPDNCT00618566
Group Therapy Program for Women With Physical Disabilities
A study testing WPD and Depression Treatment Group in people with Depressive Symptoms, run by Oregon Health and Science University at 1 site in United States.
Trial summary
More women with disabilities (30%) report "feelings such as sadness, unhappiness, or depression that prevent them from being active" compared to women without disabilities (8%). The contexts of the lives of WPD, which often include high rates of poverty, architectural and attitudinal barriers, and higher vulnerability… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- WPD and Depression Treatment Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2012
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with physical disabilities age 18 and older who require some form of accommodation and experience significant depressive symptoms as defined by a cut off score of 16 or greater on the CES-D.
Who cannot join
- Women currently receiving other psychotherapy treatment
- Women who are psychotic or have significant cognitive impairment
- Women who are actively suicidal with intent and plan
- Women who have discontinued or initiated antidepressant medications within an 4 week time period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Peer Implemented Cognitive Behavioral Group Therapy Intervention for Use With Women With Physical Disabilities With Secondary Depression
More women with disabilities (30%) report "feelings such as sadness, unhappiness, or depression that prevent them from being active" compared to women without disabilities (8%). The contexts of the lives of WPD, which often include high rates of poverty, architectural and attitudinal barriers, and higher vulnerability to violence and abuse, contribute to this mental health disparity. To help address this disparity, the overall goals of this pilot study are to: 1)1. Develop a cognitive behavioral group therapy intervention to address the specific needs of WPD who experience depressive symptoms; and 2. Pilot-test the intervention to preliminarily evaluate its efficacy using a mixed-methods approach. The proposed and revised study outcomes were derived from our previous work with WPD as well as from feedback obtained from community meetings conducted since our last submission of this proposal. A pilot of the modified intervention with a total of 90 participants will be conducted using a using a wait list control design. The decision to use a wait list control design was made jointly with our community partners to ensure that all WPD participating in the study have access to the intervention.
Read the detailed description
The project will use a longitudinal mixed method research design. Phase I will utilize focus groups conducted with WPD to support development of the group therapy program. Phase II will evaluate the efficacy of the intervention using a randomized design. Measures to protect human subjects include development of detailed safety and referral protocols including 24 hour access to emergency mental health assessment and intervention as needed.
- Conditions
- Depressive Symptoms
- Being tested
- WPD and Depression Treatment Group
- Keywords
- Women with physical Disabilities, Secondary Conditions, Depression, Cognitive Behavioral Therapy, Consumer Control
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WPD and Depression Treatment GroupBehavioural
Intervention selected will depend on Phase I data analysis.
| Study group | Role | What they receive |
|---|---|---|
| Oregon | Experimental | Not described Receives: Behavioral: WPD and Depression Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The following hypothesis is specific to the primary outcome: Hypotheses: 1. WPD receiving the intervention will demonstrate a greater improvement in depressive symptom scores compared to participants in the wait-list control groups.
Measured: 3 years
Secondary outcomes (1)
Secondary Outcomes: Hypothesis 2: the intervention group will demonstrate a greater improvement in coping and problem-solving skills, health behavior, body image and sexual self-esteem and loneliness compared to wait-listed controls.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Dena Hassouneh, Oregon Health and Science University
- Investigators
- Dena Hassouneh, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618566
- Sponsor's protocol ID
- NIDRR
- Other IDs
- H133G060135
- Acronym
- CBT-WPD
- Status last verified
- Oct 2012
- First submitted
- 8 Feb 2008
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Peer Implemented Cognitive Behavioral Group Therapy Intervention for Use With Women With Physical Disabilities With Secondary Depression
- ClinicalTrials.gov ID
- NCT00618566
- Acronym / sponsor ID
- CBT-WPD / NIDRR
- Conditions
- Depressive Symptoms
- Keywords
- Women with physical Disabilities, Secondary Conditions, Depression, Cognitive Behavioral Therapy, Consumer Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Oct 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Feb 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.
More women with disabilities (30%) report "feelings such as sadness, unhappiness, or depression that prevent them from being active" compared to women without disabilities (8%). The contexts of the lives of WPD, which often include high rates of poverty, architectural and attitudinal barriers, and higher vulnerability to violence and abuse, contribute to this mental health disparity. To help address this disparity, the overall goals of this pilot study are to: 1)1. Develop a cognitive behavioral group therapy intervention to address the specific needs of WPD who experience depressive symptoms; and 2. Pilot-test the intervention to preliminarily evaluate its efficacy using a mixed-methods approach. The proposed and revised study outcomes were derived from our previous work with WPD as well as from feedback obtained from community meetings conducted since our last submission of this proposal. A pilot of the modified intervention with a total of 90 participants will be conducted using a using a wait list control design. The decision to use a wait list control design was made jointly with our community partners to ensure that all WPD participating in the study have access to the intervention.
Detailed description
The project will use a longitudinal mixed method research design. Phase I will utilize focus groups conducted with WPD to support development of the group therapy program. Phase II will evaluate the efficacy of the intervention using a randomized design. Measures to protect human subjects include development of detailed safety and referral protocols including 24 hour access to emergency mental health assessment and intervention as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oregon | Experimental | Behavioral: WPD and Depression Treatment Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with physical disabilities age 18 and older who require some form of accommodation and experience significant depressive symptoms as defined by a cut off score of 16 or greater on the CES-D.
Key exclusion criteria (4 listed)
- Women currently receiving other psychotherapy treatment
- Women who are psychotic or have significant cognitive impairment
- Women who are actively suicidal with intent and plan
- Women who have discontinued or initiated antidepressant medications within an 4 week time period.
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 |
|---|---|---|
| WPD and Depression Treatment GroupIntervention selected will depend on Phase I data analysis. | Behavioural | Oregon |
Primary outcome
The following hypothesis is specific to the primary outcome: Hypotheses: 1. WPD receiving the intervention will demonstrate a greater improvement in depressive symptom scores compared to participants in the wait-list control groups.
Time frame: 3 years
1 secondary outcome
Secondary Outcomes: Hypothesis 2: the intervention group will demonstrate a greater improvement in coping and problem-solving skills, health behavior, body image and sexual self-esteem and loneliness compared to wait-listed controls.
Time frame: 3 years
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 17 Oct 2012.
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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.
Dena Hassouneh, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WPD and Depression Treatment Group in people with Depressive Symptoms, run by Oregon Health and Science University at 1 site in United States.
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 1 inclusion and 4 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 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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 following hypothesis is specific to the primary outcome: Hypotheses: 1. WPD receiving the intervention will demonstrate a greater improvement in depressive symptom scores compared to participants in the wait-list control groups. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2012.