NCT01401231

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

3.2 years

First QC Date

July 22, 2011

Last Update Submit

October 11, 2017

Conditions

Depression During Pregnancy

Keywords

depressionpregnancy

Outcome Measures

Primary Outcomes (1)

  • PHQ9 Depression Score

    Mean PHQ9 depression score 3 months postpartum

    3 months post-partm

Study Arms (2)

Behavioral Activation

EXPERIMENTAL

Behavioral activation psychotherapy

Behavioral: Behavioral activation psychotherapy

Usual Care

PLACEBO COMPARATOR

Continued care as usual

Other: Usual care

Interventions

Behavioral activation psychotherapyBEHAVIORAL

Up to 10 sessions of behavioral activation psychotherapy delivered in person or by telephone.

Behavioral Activation
Usual careOTHER

Continued usual care (could include referral for medication or psychotherapy)

Usual Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Pregnant PHQ9 Depression Score of 15 or greater Receiving prenatal care at one of the participating sites

You may not qualify if:

  • \- Known diagnosis of bipolar or psychotic disorder Active substance dependence Immediate risk of self harm Immediate need for inpatient mental health treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Cooperative

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • 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.

    PMID: 28045285DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2011

First Posted

July 25, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)