Behavioral Activation for Perinatal Depression

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT01401231
• Collaborator: National Institute of Mental Health (NIMH) (NIH), HealthPartners Institute (Other)
• Enrollment: 163
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 4.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression During Pregnancy	Behavioral: Behavioral activation psychotherapy; Other: Usual care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 163 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pilot Trial of Behavioral Activation Psychotherapy for Perinatal Depression
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. PHQ9 Depression Score [3 months post-partm]

   Mean PHQ9 depression score 3 months postpartum

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	Group Health Cooperative	Seattle	Washington	United States	98101

Sponsors and Collaborators

• Kaiser Permanente
• National Institute of Mental Health (NIMH)
• HealthPartners Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT01401231
• Other Study ID Numbers: U19MH092201; U19MH092201
• First Posted: Jul 25, 2011
• Last Update Posted: Oct 13, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Kaiser Permanente: depression; pregnancy
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Oct 13, 2017