Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Behavioral Activation for Perinatal Depression

This study is ongoing, but not recruiting participants.
Kaiser Permanente
HealthPartners Institute for Education and Research
Information provided by (Responsible Party):
Group Health Cooperative Identifier:
First received: July 22, 2011
Last updated: August 15, 2013
Last verified: August 2013

This pilot study will examine the feasibility, acceptability, and effectiveness of a brief behavioral activation psychotherapy for women with perinatal depression.

Condition Intervention
Depression During Pregnancy
Behavioral: Behavioral activation psychotherapy
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of Behavioral Activation Psychotherapy for Perinatal Depression

Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • PHQ9 Depression Score [ Time Frame: 3 months post-partm ] [ Designated as safety issue: No ]
    Mean PHQ9 depression score 3 months postpartum

Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Activation
Behavioral activation psychotherapy
Behavioral: 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
Other: Usual care
Continued usual care (could include referral for medication or psychotherapy)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01401231

United States, Washington
Group Health Cooperative
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Kaiser Permanente
HealthPartners Institute for Education and Research
  More Information

No publications provided

Responsible Party: Group Health Cooperative Identifier: NCT01401231     History of Changes
Other Study ID Numbers: U19 MH092201, U19MH092201
Study First Received: July 22, 2011
Last Updated: August 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Group Health Cooperative:

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders processed this record on February 25, 2015