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- Klinische proef NCT00795652
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Distance Treatment
50% randomized to receive Distance Treatment for postpartum depression
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Evidence-based, cognitive behavioural intervention for women with postpartum depression
Andere namen:
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Geen tussenkomst: Usual Care Services
50% randomized to receive usual care services for postpartum depression
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Diagnosis with SCID (Semi-structured diagnostic interview)
Tijdsspanne: baseline, 120, 240, 365
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baseline, 120, 240, 365
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Edinburgh Postnatal Depression Scale
Tijdsspanne: baseline, 120, 240, 365
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baseline, 120, 240, 365
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Sheehan Disability Scale
Tijdsspanne: Baseline, 120, 240, 365
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Baseline, 120, 240, 365
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Tevredenheidsmeting, ontworpen door de onderzoeker
Tijdsspanne: einde interventie
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einde interventie
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Beck Depression Inventory-II
Tijdsspanne: baseline, 120, 240 and 365 day follow-up
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baseline, 120, 240 and 365 day follow-up
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Patrick J McGrath, PhD, IWK Health Centre
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 3556
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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