Treatment of Depression in Mothers in Home Visitation (MIDIS)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ohio
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Cincinnati, Ohio, Forenede Stater, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
|
|
Ingen indgriben: typical home visitation
Standard of care in home visitation in which mothers can receive treatment in the community if they choose.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
maternal depression
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
parenting and child social/emotional functioning
Tidsramme: 8 months
|
Maternal report of parenting stress, observation of parenting behaviors, and maternal report of child social/emotional functioning.
|
8 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Robert T. Ammerman, Ph.D., Children's Hospital Medical Center, Cincinnati
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R34MH073867 (U.S. NIH-bevilling/kontrakt)
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