NCT01212783

Brief Summary

The purpose of this study is to determine the efficacy of In-Home Cognitive Behavioral Therapy (IH-CBT) in comparison to Present-Centered Therapy (PCT), a supportive therapeutic approach. IH-CBT is adapted form of CBT that is provided to depressed mothers participating in ongoing home visitation services. IH-CBT has been adapted to fit the setting, population, and context associated with home visiting. Mothers are recruited at 4 months postpartum. A comprehensive assessment battery is administered at pre-treatment, post-treatment, and 6, 12, and 18 months after the end of treatment. It is hypothesized that IH-CBT will be superior to PCT in decreasing depression, improving overall functioning, enhancing parenting effectiveness, and preventing relapse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

6.7 years

First QC Date

September 29, 2010

Last Update Submit

February 16, 2020

Conditions

Depressive Disorder in Mothers

Keywords

depressionpsychological treatmentsCognitive Behavioral Therapychild developmentparentinghome visitation

Outcome Measures

Primary Outcomes (1)

  • maternal depression

    Maternal depression as measured by self-report, clinician rating based on semi-structured interview, and psychiatric diagnosis based on semi-structured interview.

    23 months

Secondary Outcomes (1)

  • child development and social/emotional functioning

    23 months

Study Arms (2)

Present-Centered Therapy

ACTIVE COMPARATOR

Mothers will receive 15 weekly sessions of PCT plus two monthly booster sessions following the 15th session.

Behavioral: Present-Centered Therapy

In-Home Cognitive Behavioral Therapy

EXPERIMENTAL

Mothers will receive 15 weekly sessions of IH-CBT plus two booster sessions scheduled monthly following the 15th session.

Behavioral: In-Home Cognitive Behavioral Therapy

Interventions

In-Home Cognitive Behavioral TherapyBEHAVIORAL

Adapted form of CBT that is delivered in the home setting, uniquely designed for young, low income new mothers, and is explicitly integrated with home visitation. IH-CBT is delivered by a masters level therapist. It consists of 15 weekly sessions and two monthly booster sessions provided after the 15th session.

In-Home Cognitive Behavioral Therapy
Present-Centered TherapyBEHAVIORAL

Present-Centered Therapy is a supportive psychotherapy.

Present-Centered Therapy

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • first-time mother participating in home visitation program
  • enrolled in home visitation program for at least 2 months
  • years of age or older
  • score of 11 or higher on Edinburgh Perinatal Depression Screen at 3 months postpartum
  • diagnosis of Major Depressive Disorder using SCID
  • English speaking

You may not qualify if:

  • lifetime history of bipolar disorder, schizophrenia, mental retardation, organic brain syndrome, antisocial personality disorder
  • history of psychosis
  • current substance dependence
  • current antidepressant use or other mood altering medications and/or current involvement in psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Robert T. Ammerman, Ph.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 29, 2010

First Posted

October 1, 2010

Study Start

October 1, 2010

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

US(1)