- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01401231
Behavioral Activation for Perinatal Depression
October 11, 2017 updated by: Kaiser Permanente
Pilot Trial of Behavioral Activation Psychotherapy for Perinatal Depression
This pilot study will examine the feasibility, acceptability, and effectiveness of a brief behavioral activation psychotherapy for women with perinatal depression.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
163
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98101
- Group Health Cooperative
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pregnant PHQ9 Depression Score of 15 or greater Receiving prenatal care at one of the participating sites
Exclusion Criteria:
- Known diagnosis of bipolar or psychotic disorder Active substance dependence Immediate risk of self harm Immediate need for inpatient mental health treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral Activation
Behavioral activation psychotherapy
|
Up to 10 sessions of behavioral activation psychotherapy delivered in person or by telephone.
|
Placebo Comparator: Usual Care
Continued care as usual
|
Continued usual care (could include referral for medication or psychotherapy)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PHQ9 Depression Score
Time Frame: 3 months post-partm
|
Mean PHQ9 depression score 3 months postpartum
|
3 months post-partm
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
July 22, 2011
First Submitted That Met QC Criteria
July 22, 2011
First Posted (Estimate)
July 25, 2011
Study Record Updates
Last Update Posted (Actual)
October 13, 2017
Last Update Submitted That Met QC Criteria
October 11, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U19MH092201 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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