Clinical trial NCT05044455: Online Peer-Delivered Group CBT for PPD
Official title: Online Peer-Delivered Group CBT for Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Keywords: CBT
Postpartum Depression
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-09-14
Enrollment: 191
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial - Treatment group receives a 9 week on-line CBT treatment delivered by Peer facilitators as well as accessing treatment as usual for new mothers experiencing postpartum depression.

Control Group accesses treatment as usual or typical treatment for new mothers in participant's communities and does not receive the CBT group.
Primary purpose: TREATMENT

Brief summary: Mothers and birthing parents (hereafter referred to as mothers) who have recovered from Postpartum Depression and are well now, receive training to teach a 9 week Cognitive Behavioural Therapy (CBT) treatment to mothers who are feeling depressed after giving birth in the last year. Eligible mothers are randomly assigned to one of two groups. Mothers in one group will receive a 9 week group CBT intervention delivered online by the trained Peer facilitators. Mothers in the other group will not receive the CBT group intervention and will continue to receive treatment as usual or regular care for new mothers.

Mothers in both groups will complete online questionnaires three times - when participants start the study, nine weeks later and six months after that. Mothers in the intervention group will also complete a few questionnaires once during the intervention and a satisfaction questionnaire at end of intervention. Participant information will help determine if the CBT treatment is helpful for postpartum depression.

Detailed description: Mothers and birthing parents (hereafter referred to as mothers) who meet the eligibility criteria for the study (18+ years of age, with a baby under 12 months of age at recruitment, Edinburgh Postnatal Depression Scale (EPDS) score of 10 - 22 and living in Ontario are screened using the Mini International Neuropsychiatric Interview (MINI). Mothers free of bipolar, psychotic or current substance use disorders and borderline personality disorder are randomized 1:1 to the intervention (online 9 week peer-delivered CBT program) or control group (treatment as usual, TAU) after providing informed consent.

Participants in the Intervention Group receive a 9 week on-line CBT group (2 hrs weekly) delivered by Peer facilitators who have recovered from Postpartum Depression (PPD) and have been trained to deliver CBT. Participants may also continue to receive treatment as usual (medication, psychotherapy), or typical care, for new mothers from any source (healthcare providers, etc).

Participants in the Control Group do not receive the CBT group and are given a list of resources for mental health and postpartum depression supports and are also encouraged to seek treatment as usual or typical care for new mothers from any source. Participants will also receive follow up emails monthly with information about when to seek emergency treatment (if symptoms worsen, experience thoughts of self-harm or harm to the participant's baby).

All participants will receive personalized emails with links to participant's online questionnaires through REDCap at 3 time points (recruitment, nine weeks later and 6 months later). Participants in the intervention group will also complete questionnaires at one time point during the intervention and a satisfaction survey at end of intervention. The data from both groups will be examined to determine treatment effects and durability, respectively.

Peer facilitator fidelity to the CBT Model will be assessed using measures of adherence and competence and independently assessed by two raters.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* baby under 12 months of age at recruitment
* EPDS score 10 - 22
* lives in Ontario
* fluent in written/spoken English

Exclusion Criteria:

* Mothers and birthing parents who score positive on the MINI subsections of bipolar, psychotic, current substance abuse disorders and/or borderline personality disorder

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 9 weeks
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 6 months
measure: MINI International Neuropsychiatric Interview
timeFrame: 9 weeks
measure: MINI International Neuropsychiatric Interview
timeFrame: 6 months
Secondary outcomes:
measure: GAD-7
timeFrame: 9 weeks
measure: GAD-7
timeFrame: 6 months
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 9 weeks
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 6 months
measure: The Postpartum Bonding Questionnaire (PBQ)
timeFrame: 9 weeks
measure: The Postpartum Bonding Questionnaire (PBQ)
timeFrame: 6 months
measure: Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)
timeFrame: 9 weeks
measure: Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)
timeFrame: 6 months
measure: EQ-5D-5L
timeFrame: 9 weeks
measure: EQ-5D-5L
timeFrame: 6 months
measure: Healthcare Resource Utilization Questionnaire
timeFrame: 9 weeks
measure: Healthcare Resource Utilization Questionnaire
timeFrame: 6 months
Other outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 9 weeks
measure: CBT Skills Questionnaire (CBTSQ)
timeFrame: 4 weeks
measure: CBT Skills Questionnaire (CBTSQ)
timeFrame: 9 weeks
measure: Working Alliance Inventory (WAI-SR)
timeFrame: 4 weeks
measure: Working Alliance Inventory (WAI-SR)
timeFrame: 9 weeks
measure: Peer Support Integrity, Quality and Impact Survey (PSIQI)
timeFrame: 4 weeks
measure: Peer Support Integrity, Quality and Impact Survey (PSIQI)
timeFrame: 9 weeks
measure: Therapeutic Factors Inventory 8 (TFI-8)
timeFrame: 4 weeks
measure: Therapeutic Factors Inventory 8 (TFI-8)
timeFrame: 9 weeks
measure: Adherence Checklist
timeFrame: Weekly, weeks 1 through 9 of intervention
measure: Competence Checklist
timeFrame: Weekly, weeks 1 through 9 of intervention
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Ryan Van Lieshout, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Crick K, Al Sayah F, Ohinmaa A, Johnson JA. Responsiveness of the anxiety/depression dimension of the 3- and 5-level versions of the EQ-5D in assessing mental health. Qual Life Res. 2018 Jun;27(6):1625-1633. doi: 10.1007/s11136-018-1828-1. Epub 2018 Mar 7.
citation: Xie F, Pullenayegum E, Gaebel K, Bansback N, Bryan S, Ohinmaa A, Poissant L, Johnson JA; Canadian EQ-5D-5L Valuation Study Group. A Time Trade-off-derived Value Set of the EQ-5D-5L for Canada. Med Care. 2016 Jan;54(1):98-105. doi: 10.1097/MLR.0000000000000447.
citation: 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.
citation: 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.
citation: 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.
citation: Putnam SP, Helbig AL, Gartstein MA, Rothbart MK, Leerkes E. Development and assessment of short and very short forms of the infant behavior questionnaire-revised. J Pers Assess. 2014;96(4):445-58. doi: 10.1080/00223891.2013.841171. Epub 2013 Nov 9.
citation: 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
citation: Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.
citation: Hepner KA, Howard S, Paddock SM, et al. A Fidelity Coding guide for a Group Cognitive Behavioral Therapy for Depression: RAND Corporation. 2011
citation: Jacob KL, Christopher MS, Neuhaus EC. Development and validation of the cognitive-behavioral therapy skills questionnaire. Behav Modif. 2011 Nov;35(6):595-618. doi: 10.1177/0145445511419254. Epub 2011 Sep 5.
citation: Munder T, Wilmers F, Leonhart R, Linster HW, Barth J. Working Alliance Inventory-Short Revised (WAI-SR): psychometric properties in outpatients and inpatients. Clin Psychol Psychother. 2010 May-Jun;17(3):231-9. doi: 10.1002/cpp.658.
citation: Peer Support Integrity, Quality and Impact Survey, 1.1 ed. Centre for Innovation in Peer Support. Hamilton, ON, Canada. April. 2019
citation: Matsubara C, Green J, Astorga LT, Daya EL, Jervoso HC, Gonzaga EM, Jimba M. 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 Childbirth. 2013 Dec 17;13:235. doi: 10.1186/1471-2393-13-235.