Study Summary
This trial is testing whether a group CBT intervention, delivered online by trained Peer facilitators, is helpful for postpartum depression.
Eligible Conditions
- Postpartum Depression
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 11 Secondary · Reporting Duration: 6 months
6 months
Dyadic Adjustment Scale (DAS)
EQ-5D-5L
Early Child Behavior Questionnaire-Very Short Version
Edinburgh Postnatal Depression Scale (EPDS)
GAD-7
Healthcare Resource Utilization Questionnaire
Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)
MINI International Neuropsychiatric Interview
Multidimensional Scale of Perceived Social Support (MSPSS)
Parenting Stress Index (PSI-SF)
Social Provisions Scale (SPS)
Strengths and Difficulties Questionnaire
The Postpartum Bonding Questionnaire (PBQ)
9 weeks
CBT Skills Questionnaire (CBTSQ)
Client Satisfaction Questionnaire (CSQ-8)
Peer Support Integrity, Quality and Impact Survey (PSIQI)
Therapeutic Factors Inventory 8 (TFI-8)
Working Alliance Inventory (WAI-SR)
Week 1
Adherence Checklist
Competence Checklist
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Arm 2: Control Group
1 of 2
Arm 1: Experimental, intervention
1 of 2
Active Control
Experimental Treatment
167 Total Participants · 2 Treatment Groups
Primary Treatment: Cognitive Behavioural Therapy (CBT) · No Placebo Group · N/A
Arm 1: Experimental, intervention
Behavioral
Experimental Group · 1 Intervention: Cognitive Behavioural Therapy (CBT) · Intervention Types: BehavioralArm 2: Control GroupNoIntervention Group · 1 Intervention: Arm 2: Control Group · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioural Therapy (CBT)
2017
N/A
~390
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Who is running the clinical trial?
McMaster UniversityLead Sponsor
801 Previous Clinical Trials
1,727,710 Total Patients Enrolled
11 Trials studying Postpartum Depression
2,511 Patients Enrolled for Postpartum Depression
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,232 Previous Clinical Trials
24,675,485 Total Patients Enrolled
4 Trials studying Postpartum Depression
994 Patients Enrolled for Postpartum Depression
Ryan Van Lieshout, MD PhDPrincipal InvestigatorMcMaster University
Eligibility Criteria
Age 18 - 99 · Female Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are eligible for screening if you are at least 18 years of age.
References
- Xie, Feng, Eleanor Pullenayegum, Kathy Gaebel, Nick Bansback, Stirling Bryan, Arto Ohinmaa, Lise Poissant, and Jeffrey A. Johnson. 2016. “A Time Trade-off-derived Value Set of the EQ-5D-5L for Canada”. Medical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mlr.0000000000000447.
- Bourdon, Karen H., Robert Goodman, Donald S. Rae, Gloria Simpson, and Doreen S. Koretz. 2005. “The Strengths and Difficulties Questionnaire: U.S. Normative Data and Psychometric Properties”. Journal of the American Academy of Child & Adolescent Psychiatry. Elsevier BV. doi:10.1097/01.chi.0000159157.57075.c8.
- Cox, J. L., J. M. Holden, and R. Sagovsky. 1987. “Detection of Postnatal Depression”. British Journal of Psychiatry. Royal College of Psychiatrists. doi:10.1192/bjp.150.6.782.
- Putnam, Samuel P., Amy L. Helbig, Maria A. Gartstein, Mary K. Rothbart, and Esther Leerkes. 2013. “Development and Assessment of Short and Very Short Forms of the Infant Behavior Questionnaire–revised”. Journal of Personality Assessment. Informa UK Limited. doi:10.1080/00223891.2013.841171.
- Spitzer, Robert L., Kurt Kroenke, Janet B. W. Williams, and Bernd Löwe. 2006. “A Brief Measure for Assessing Generalized Anxiety Disorder”. Archives of Internal Medicine. American Medical Association (AMA). doi:10.1001/archinte.166.10.1092.
- Loyd, Brenda H., and Richard R. Abidin. 1985. “Revision of the Parenting Stress Index”. Journal of Pediatric Psychology. Oxford University Press (OUP). doi:10.1093/jpepsy/10.2.169.
- Crick, Katelynn, Fatima Al Sayah, Arto Ohinmaa, and Jeffrey A. Johnson. 2018. “Responsiveness of the Anxiety/depression Dimension of the 3- and 5-level Versions of the EQ-5D in Assessing Mental Health”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1007/s11136-018-1828-1.
- Putnam, Samuel P., and Mary K. Rothbart. 2006. “Development of Short and Very Short Forms of the Children's Behavior Questionnaire”. Journal of Personality Assessment. Informa UK Limited. doi:10.1207/s15327752jpa8701_09.
- Massoubre, C., H. Bonnefond, A. Grosselin, A. Nelva, J. Pellet, and F. Lang. 2009. “Étude préliminaire comparative de l’instrument d’évaluation des troubles de la personnalité DIP avec l’entretien semi-structuré SCID-II”. L'encéphale. Elsevier BV. doi:10.1016/j.encep.2008.09.007.
- Brockington, I. F., C. Fraser, and D. Wilson. 2006. “The Postpartum Bonding Questionnaire: A Validation”. Archives of Women's Mental Health. Springer Science and Business Media LLC. doi:10.1007/s00737-006-0132-1.
- Jacob, Karen L., Michael S. Christopher, and Edmund C. Neuhaus. 2011. “Development and Validation of the Cognitive-behavioral Therapy Skills Questionnaire”. Behavior Modification. SAGE Publications. doi:10.1177/0145445511419254.
- Matsubara, Chieko, Joseph Green, Linda Teresa Astorga, Edgardo L Daya, Honorato C Jervoso, Edgardo M Gonzaga, and Masamine Jimba. 2013. “Reliability Tests and Validation Tests of the Client Satisfaction Questionnaire (CSQ-8) as an Index of Satisfaction with Childbirth-related Care Among Filipino Women”. BMC Pregnancy and Childbirth. Springer Science and Business Media LLC. doi:10.1186/1471-2393-13-235.
- Hepner KA, Howard S, Paddock SM, et al. A Fidelity Coding guide for a Group Cognitive Behavioral Therapy for Depression: RAND Corporation. 2011
- Chiara G, Eva G, Elisa M, et al. Psychometrical properties of the Dyadic Adjustment Scale for measurement of marital quality with Italian couples. Procedia-Social and Behavioral Sciences. 2014;127:499-503. doi:10.1016/j.sbspro.2014.03.298
- Zimet GD, Dahlem NW, Zimet SG, et al. The multidimensional scale of perceived social support. Journal of Personality Assessment. 1988;52(1):30-41. doi:10.1207/s15327752jpa5201_2
- Peer Support Integrity, Quality and Impact Survey, 1.1 ed. Centre for Innovation in Peer Support. Hamilton, ON, Canada. April. 2019
- Munder, Thomas, Fabian Wilmers, Rainer Leonhart, Hans Wolfgang Linster, and Jürgen Barth. 2009. “Working Alliance Inventory-short Revised (WAI-SR): Psychometric Properties in Outpatients and Inpatients”. Clinical Psychology & Psychotherapy. Wiley. doi:10.1002/cpp.658.
- Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
- Brockington IF, Fraser C, Wilson D. The Postpartum Bonding Questionnaire: a validation. Arch Womens Ment Health. 2006 Sep;9(5):233-42. doi: 10.1007/s00737-006-0132-1. Epub 2006 May 4.
- Loyd BH, Abidin RR. Revision of the Parenting Stress Index. J Pediatr Psychol. 1985 Jun;10(2):169-77. doi: 10.1093/jpepsy/10.2.169. No abstract available.
- Ryan Van Lieshout, MD, PhD 2022. "Online Peer-Delivered Group CBT for PPD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05044455.
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Conditions
Cancer Related
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