Behavioral Activation for Perinatal Depression
Primary Purpose
Depression During Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral activation psychotherapy
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Depression During Pregnancy focused on measuring depression, pregnancy
Eligibility Criteria
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
Sites / Locations
- Group Health Cooperative
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Behavioral Activation
Usual Care
Arm Description
Behavioral activation psychotherapy
Continued care as usual
Outcomes
Primary Outcome Measures
PHQ9 Depression Score
Mean PHQ9 depression score 3 months postpartum
Secondary Outcome Measures
Full Information
NCT ID
NCT01401231
First Posted
July 22, 2011
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
National Institute of Mental Health (NIMH), HealthPartners Institute
1. Study Identification
Unique Protocol Identification Number
NCT01401231
Brief Title
Behavioral Activation for Perinatal Depression
Official Title
Pilot Trial of Behavioral Activation Psychotherapy for Perinatal Depression
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Institute of Mental Health (NIMH), HealthPartners Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study will examine the feasibility, acceptability, and effectiveness of a brief behavioral activation psychotherapy for women with perinatal depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression During Pregnancy
Keywords
depression, pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Activation
Arm Type
Experimental
Arm Description
Behavioral activation psychotherapy
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Continued care as usual
Intervention Type
Behavioral
Intervention Name(s)
Behavioral activation psychotherapy
Intervention Description
Up to 10 sessions of behavioral activation psychotherapy delivered in person or by telephone.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Continued usual care (could include referral for medication or psychotherapy)
Primary Outcome Measure Information:
Title
PHQ9 Depression Score
Description
Mean PHQ9 depression score 3 months postpartum
Time Frame
3 months post-partm
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Group Health Cooperative
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28045285
Citation
Dimidjian S, Goodman SH, Sherwood NE, Simon GE, Ludman E, Gallop R, Welch SS, Boggs JM, Metcalf CA, Hubley S, Powers JD, Beck A. A pragmatic randomized clinical trial of behavioral activation for depressed pregnant women. J Consult Clin Psychol. 2017 Jan;85(1):26-36. doi: 10.1037/ccp0000151.
Results Reference
derived
Learn more about this trial
Behavioral Activation for Perinatal Depression
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