Treatment of Depression in Mothers in Home Visitation (MIDIS)

This study develops and contrasts In-Home Cognitive Behavioral Therapy (IH-CBT), an adapted evidence-based treatment for depressed mothers participating in home visitation, with typical home visitation in which treatment may be obtained in the community. Mothers will be identified using a two step process consisting of administration of a screen and subsequent diagnosis of Major Depressive Disorder. The will then be randomized into the treatment and control conditions. A comprehensive assessment of depression and related areas of functioning will be administered at pre-treatment, post-treatment, and 3 month follow-up. It is hypothesized that IH-CBT will lead to broad and durable gains in mood and social support relative to those in typical home visitation.

Study Overview

Detailed Description

This study involves the development and preliminarily testing of In-Home Cognitive Behavioral Therapy (IH-CBT), a psychological treatment grounded in the cognitive model but adapted for administration in conjunction with home visitation. IH-CBT is designed to (1) use the techniques and approaches of CBT which have received strong empirical support, (2) be implemented in the home setting, (3) meet the needs of young postpartum mothers in their first year of home visitation, and (4) be seamlessly integrated with home visitation to maximize the likelihood of recovery from depression, prevent relapse, and increase of the benefits of home visitation. IH-CBT will be delivered by trained therapist who will provide 15 treatment sessions followed by a 1 month booster session. A small-scale randomized clinical trial will be conducted contrasting IH-CBT delivered in conjunction with home visitation and home visitation alone ("typical home visitation"-THV). Mothers in the THV condition will be able to obtain treatment in the community if they choose.

Mothers will be identified based on obtaining a score of ≥12 on the Edinburgh Perinatal Depression Screen administered by home visitors at 3 months postpartum. Final eligibility will be determined based on subsequently obtaining a diagnosis of Major Depressive Disorder (MDD) using the SCID. A comprehensive assessment of depression, other psychiatric symptoms, social support and network, and parenting and child adjustment will be administered at pre-treatment, post-treatment, and 3 month follow-up. Ratings of MDD at post-treatment and follow-up will be conducted by clinicians blind to condition.

The following hypotheses will be tested:

Hypothesis 1. Mothers in IH-CBT will report greater reductions in self-reported and clinician-rated depression at post-treatment and follow up relative to THV.

Hypothesis 2. Mothers in IH-CBT will report improvements in overall functioning, social support, social network, and general psychiatric symptomatology at post-treatment and follow up relative to IH-CBT.

Hypothesis 3. Mothers who recover from depression at post-treatment will report improvements in parenting and child adjustment relative to those who do not recover.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • first-time mother participating in home visitation program
  • enrolled in home visitation program for at least 2 months
  • 16 years of age or older
  • score of 12 or higher on Edinburgh Perinatal Depression Screen at 3 months postpartum
  • diagnosis of Major Depressive Disorder using the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders
  • English speaking

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: In-Home Cognitive Behavioral Therapy
Mothers will receive 15 weekly sessions of IH-CBT plus one booster session scheduled 1 month later.
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 1 booster session provided 1 month after the 15th session.
Other Names:
  • IH-CBT
No Intervention: typical home visitation
Standard of care in home visitation in which mothers can receive treatment in the community if they choose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal depression
Time Frame: 8 months
Maternal depression as measured by self-report, clinician rating based on semi-structured interview, and psychiatric diagnosis based on semi-structured interview.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
parenting and child social/emotional functioning
Time Frame: 8 months
Maternal report of parenting stress, observation of parenting behaviors, and maternal report of child social/emotional functioning.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert T. Ammerman, Ph.D., Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 14, 2010

First Posted (Estimate)

October 15, 2010

Study Record Updates

Last Update Posted (Estimate)

March 18, 2013

Last Update Submitted That Met QC Criteria

March 15, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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