Mom: Managing Our Mood, Part of The Family Help Program (MOM)
Evidence-based, Distance Treatment for Postpartum Depression, Mom: Managing Our Mood, Part of The Family Help Program
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The Family Help- MOM: Managing Our Mood Program is to deliver, primary care mental health services to mothers in the comfort and privacy of their own home. The purpose of this randomized control trial is to test the effectiveness of the Managing Our Mood (MOM) postpartum depression distance treatment program. This study is a single-centre trial based at the IWK Health Centre, similar to other Family Help Modules.
The goal of this study is to determine the effectiveness of the MOM cognitive-behavioural intervention as an alternative treatment for women suffering from postpartum depression. The intervention is delivered at a distance, using educational materials (handbooks, video-tapes/DVDs, and telephone consultation with a trained paraprofessional coach. Family Help coaches deliver consistent care based on written protocols, with on-going evaluation by a professional team. MOM is not designed to replace specialist care of complex multi-problem mothers.
Eligible participants will be randomly assigned to either active MOM treatment or to the Best Efforts control condition. Those participants assigned to Best Efforts receive printed information about postpartum depression that describes the illness, how it is caused and various treatment options; they are assigned a Coach who books their assessments and is available to answer any questions; they are encouraged to maintain contact and regular care with their family physician or public health nurse for both themselves and their baby. At the end of the 12-month follow-up (one year from randomization), these women will be offered the opportunity to take part in the MOM treatment if they are still depressed.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Completed diagnostic measure (SCID), reviewed and signed off by a psychologist
- Participant must meet DSM-IV criteria for postpartum depression
- Significant depressive symptoms that have been present for at least 2 weeks
- Participant must be within 1-12 months postpartum
- Participant must have ready private access to a telephone
- Participant must be between 19-45 years old
- Participant has provided verbal telephone consent
- Participants must speak, read and write in English
- If they are taking medication they must be stabilized (have been on the medication for at least four weeks).
Exclusion Criteria:
- Any condition that in the judgment of the psychologist may interfere with effective delivery of the treatment program (ie, Severe symptomology, challenging diagnostic dilemmas, families who are unmotivated or are in complete chaos)
- Current reports of specific suicidal intentions
- Actively suicidal; suicidal attempts in the previous 6 months
- Participants who are not willing to commit to the demands of treatment
- Participants who have had psychological treatment in the past 6 months for similar problems.
- Participants who have a history of psychotic disorders
- Participants who are cognitively impaired
- Participants who are involved with child protection services
- Participants who have significant substance dependency
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Distance Treatment
50% randomized to receive Distance Treatment for postpartum depression
|
Evidence-based, cognitive behavioural intervention for women with postpartum depression
Andre navn:
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Ingen inngripen: Usual Care Services
50% randomized to receive usual care services for postpartum depression
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Diagnosis with SCID (Semi-structured diagnostic interview)
Tidsramme: baseline, 120, 240, 365
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baseline, 120, 240, 365
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Edinburgh Postnatal Depression Scale
Tidsramme: baseline, 120, 240, 365
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baseline, 120, 240, 365
|
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Sheehan Disability Scale
Tidsramme: Baseline, 120, 240, 365
|
Baseline, 120, 240, 365
|
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Tilfredshetsmål, designet av etterforskeren
Tidsramme: slutt på intervensjon
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slutt på intervensjon
|
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Beck Depression Inventory-II
Tidsramme: baseline, 120, 240 and 365 day follow-up
|
baseline, 120, 240 and 365 day follow-up
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Patrick J McGrath, PhD, IWK Health Centre
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. doi: 10.1258/135763306779378690.
- Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. doi: 10.1097/01.ANS.0000300184.94595.25.
- Lingley-Pottie P, McGrath PJ. A paediatric therapeutic alliance occurs with distance intervention. J Telemed Telecare. 2008;14(5):236-40. doi: 10.1258/jtt.2008.080101.
- McGrath PJ, Lingley-Pottie P, Emberly DJ, Thurston C, McLean C. Integrated knowledge translation in mental health: family help as an example. J Can Acad Child Adolesc Psychiatry. 2009 Feb;18(1):30-7.
- Lingley-Pottie P, McGrath PJ. Telehealth: a child and family-friendly approach to mental health-care reform. J Telemed Telecare. 2008;14(5):225-6. doi: 10.1258/jtt.2008.008001.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 3556
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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