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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Distance Treatment
50% randomized to receive Distance Treatment for postpartum depression
|
Evidence-based, cognitive behavioural intervention for women with postpartum depression
Autres noms:
|
|
Aucune intervention: Usual Care Services
50% randomized to receive usual care services for postpartum depression
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Diagnosis with SCID (Semi-structured diagnostic interview)
Délai: baseline, 120, 240, 365
|
baseline, 120, 240, 365
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Edinburgh Postnatal Depression Scale
Délai: baseline, 120, 240, 365
|
baseline, 120, 240, 365
|
|
Sheehan Disability Scale
Délai: Baseline, 120, 240, 365
|
Baseline, 120, 240, 365
|
|
Mesure de satisfaction, conçue par l'investigateur
Délai: fin d'intervention
|
fin d'intervention
|
|
Beck Depression Inventory-II
Délai: baseline, 120, 240 and 365 day follow-up
|
baseline, 120, 240 and 365 day follow-up
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Patrick J McGrath, PhD, IWK Health Centre
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 3556
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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