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Behavioral Activation for Perinatal Depression

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Kaiser Permanente
HealthPartners Institute
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT01401231
First received: July 22, 2011
Last updated: August 9, 2016
Last verified: August 2016
  Purpose
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
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 ]
    Mean PHQ9 depression score 3 months postpartum


Enrollment: 163
Study Start Date: August 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (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)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  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 ClinicalTrials.gov identifier: NCT01401231

Locations
United States, Washington
Group Health Cooperative
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
National Institute of Mental Health (NIMH)
Kaiser Permanente
HealthPartners Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT01401231     History of Changes
Other Study ID Numbers: U19MH092201 ( US NIH Grant/Contract Award Number )
Study First Received: July 22, 2011
Last Updated: August 9, 2016

Keywords provided by Group Health Cooperative:
depression
pregnancy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 26, 2017