Depressive Disorder in Mothers Clinical Trial
Official title:
Treatment of Depression in Mothers in Home Visitation
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01212783 -
Treatment of Maternal Depression in Home Visitation: Mother and Child Impacts
|
N/A |