Treatment of Depression in Mothers in Home Visitation (MIDIS)
Primary Purpose
Depressive Disorder in Mothers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-Home Cognitive Behavioral Psychology
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder in Mothers focused on measuring depression, psychological treatments, Cognitive Behavioral Therapy, child social/emotional functioning, parenting, home visitation
Eligibility Criteria
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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
In-Home Cognitive Behavioral Therapy
typical home visitation
Arm Description
Mothers will receive 15 weekly sessions of IH-CBT plus one booster session scheduled 1 month later.
Standard of care in home visitation in which mothers can receive treatment in the community if they choose.
Outcomes
Primary Outcome Measures
maternal depression
Maternal depression as measured by self-report, clinician rating based on semi-structured interview, and psychiatric diagnosis based on semi-structured interview.
Secondary Outcome Measures
parenting and child social/emotional functioning
Maternal report of parenting stress, observation of parenting behaviors, and maternal report of child social/emotional functioning.
Full Information
NCT ID
NCT01221701
First Posted
October 14, 2010
Last Updated
March 15, 2013
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT01221701
Brief Title
Treatment of Depression in Mothers in Home Visitation
Acronym
MIDIS
Official Title
Treatment of Depression in Mothers in Home Visitation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder in Mothers
Keywords
depression, psychological treatments, Cognitive Behavioral Therapy, child social/emotional functioning, parenting, home visitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In-Home Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Mothers will receive 15 weekly sessions of IH-CBT plus one booster session scheduled 1 month later.
Arm Title
typical home visitation
Arm Type
No Intervention
Arm Description
Standard of care in home visitation in which mothers can receive treatment in the community if they choose.
Intervention Type
Behavioral
Intervention Name(s)
In-Home Cognitive Behavioral Psychology
Other Intervention Name(s)
IH-CBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
maternal depression
Description
Maternal depression as measured by self-report, clinician rating based on semi-structured interview, and psychiatric diagnosis based on semi-structured interview.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
parenting and child social/emotional functioning
Description
Maternal report of parenting stress, observation of parenting behaviors, and maternal report of child social/emotional functioning.
Time Frame
8 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert T. Ammerman, Ph.D.
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20401324
Citation
Ammerman RT, Putnam FW, Bosse NR, Teeters AR, Van Ginkel JB. Maternal Depression in Home Visitation: A Systematic Review. Aggress Violent Behav. 2010 May;15(3):191-200. doi: 10.1016/j.avb.2009.12.002.
Results Reference
background
PubMed Identifier
20936338
Citation
Ammerman RT, Putnam FW, Stevens J, Bosse NR, Short JA, Bodley AL, Van Ginkel JB. An open trial of in-home CBT for depressed mothers in home visitation. Matern Child Health J. 2011 Nov;15(8):1333-41. doi: 10.1007/s10995-010-0691-7.
Results Reference
background
Learn more about this trial
Treatment of Depression in Mothers in Home Visitation
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