DepressionNCT00788814
Study of Pathways Curriculum for Use With WPD
A study testing Pathways in people with Depression, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Study to assess the efficacy of a modified Pathways curriculum in treating depressive symptoms in women with physical disabilities. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression
- What is being tested?
- Pathways
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jan 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 disability requiring accommodation for major mobility limitations
- CES-D score of 16 or higher -
Who cannot join
- Active suicidality
- Diagnosis of Schizophrenia, Schizoaffective D/O, Psychosis NOS
- Currently receiving other psychotherapy -
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97236
About this study
Official title: Women Physical Disability and Depression: Communities Responding Now!
Study to assess the efficacy of a modified Pathways curriculum in treating depressive symptoms in women with physical disabilities.
- Conditions
- Depression
- Being tested
- Pathways
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PathwaysBehavioural
Strength-based curriculum addressing depression in women with with physical disabilities
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Control group Receives: Behavioral: Pathways |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: pre-test, post-test weeks, 12, 18, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Portland State University
- Responsible party
- Principal investigator, Dena Hassouneh, Oregon Health and Science University
- Investigators
- Dena M Hassouneh, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788814
- Sponsor's protocol ID
- 1R01MH079818-01A1
- Other IDs
- 1R01MH079818-01A1
- Status last verified
- Oct 2012
- First submitted
- 10 Nov 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
- Women Physical Disability and Depression: Communities Responding Now!
- ClinicalTrials.gov ID
- NCT00788814
- Acronym / sponsor ID
- 1R01MH079818-01A1
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Portland State University
- Study start
- Jun 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Nov 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.
Study to assess the efficacy of a modified Pathways curriculum in treating depressive symptoms in women with physical disabilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: PathwaysControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with physical disability requiring accommodation for major mobility limitations
- CES-D score of 16 or higher -
Key exclusion criteria (3 listed)
- Active suicidality
- Diagnosis of Schizophrenia, Schizoaffective D/O, Psychosis NOS
- Currently receiving other psychotherapy -
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 |
|---|---|---|
| PathwaysStrength-based curriculum addressing depression in women with with physical disabilities | Behavioural | Control |
Primary outcome
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: pre-test, post-test weeks, 12, 18, 24
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 M 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 Pathways in people with Depression, 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 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 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?
Center for Epidemiologic Studies Depression Scale (CES-D) (time frame: pre-test, post-test weeks, 12, 18, 24). 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.