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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01401231
Other study ID # U19MH092201
Secondary ID U19MH092201
Status Completed
Phase N/A
First received July 22, 2011
Last updated October 11, 2017
Start date August 2011
Est. completion date October 2014

Study information

Verified date October 2017
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 163
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Behavioral activation psychotherapy
Up to 10 sessions of behavioral activation psychotherapy delivered in person or by telephone.
Other:
Usual care
Continued usual care (could include referral for medication or psychotherapy)

Locations

Country Name City State
United States Group Health Cooperative Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
Kaiser Permanente HealthPartners Institute, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PHQ9 Depression Score Mean PHQ9 depression score 3 months postpartum 3 months post-partm