Treatment of Depression in Mothers in Home Visitation

Depressive Disorder in Mothers Clinical Trial

— MIDIS  

Official title:

Treatment of Depression in Mothers in Home Visitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221701
• Other study ID #: R34MH073867
• Status: Completed
• Phase: N/A
• First received: October 14, 2010
• Last updated: March 15, 2013
• Start date: October 2006
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: February 2013
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder in Mothers

Intervention

Behavioral:
• In-Home Cognitive Behavioral Psychology
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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maternal depression	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	parenting and child social/emotional functioning	Maternal report of parenting stress, observation of parenting behaviors, and maternal report of child social/emotional functioning.	8 months