Online Peer-Delivered Group CBT for PPD

NCT05044455 | Completed

• 1 other identifier: OnlinePeerCBT
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Keywords

CBT; Postpartum Depression

Outcome Measures

Primary Outcomes (4)

• Edinburgh Postnatal Depression Scale (EPDS)

  The Edinburgh Postnatal Depression Scale (EPDS) is the 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms.. A score ≥13 is consistent with PPD and changes in scores \>4 are accepted as being indicative of clinically significant change

  9 weeks

• Edinburgh Postnatal Depression Scale (EPDS)

  The Edinburgh Postnatal Depression Scale (EPDS) is the 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms.. A score ≥13 is consistent with PPD and changes in scores \>4 are accepted as being indicative of clinically significant change

  6 months

• MINI International Neuropsychiatric Interview

  A brief structured interview for the major Axis 1 psychiatric disorders in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM 5) . Major Depressive Disorder Module to determine if participants meet diagnostic criteria for PPD at 9 weeks

  9 weeks

• MINI International Neuropsychiatric Interview

  A brief structured interview for the major Axis 1 psychiatric disorders in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM 5). Major Depressive Disorder Module to determine if participants meet diagnostic criteria for PPD at six months

  6 months

Secondary Outcomes (12)

• GAD-7

  9 weeks

• GAD-7

  6 months

• Multidimensional Scale of Perceived Social Support (MSPSS)

  9 weeks

• Multidimensional Scale of Perceived Social Support (MSPSS)

  6 months

• The Postpartum Bonding Questionnaire (PBQ)

  9 weeks

Other Outcomes (11)

• Client Satisfaction Questionnaire (CSQ-8)

  9 weeks

• CBT Skills Questionnaire (CBTSQ)

  4 weeks

• CBT Skills Questionnaire (CBTSQ)

  9 weeks

Study Arms (2)

Arm 1: Experimental, intervention

EXPERIMENTAL

The immediate intervention group will receive an online 9 week CBT intervention led by trained peers who have themselves recovered from postpartum depression. The CBT group will be two hours long, weekly and involves teaching and practice of core CBT skills. Core cognitive skills including thought records and cognitive restructuring are introduced and practiced from week 1. Behavioural techniques are introduced at week 2 and continue throughout the group, including behavioural activation, relaxation techniques, sleep strategies, exercise and goal setting. Each participant will receive a professionally design CBT manual to facilitate learning. Participants in the intervention group may also receive typical care or treatment as usual for new mothers.

Behavioral: Cognitive Behavioural Therapy (CBT)

Arm 2: Control Group

NO INTERVENTION

The control group will receive treatment as usual (TAU) or typical care available for postpartum depression in participant's home communities, via participant's family doctor, mental health services, midwifery services, etc. Subjects in the control group will receive a list of resources where participants may seek treatment and will receive a monthly email encouraging them to seek treatment if symptoms worsen, including thoughts of self harm or harm to participant's child. Participants will also receive a copy of the Canadian Practice Guidelines for the treatment of PPD.

Interventions

Cognitive Behavioural Therapy (CBT) BEHAVIORAL

A 9 week CBT group, 2 hours weekly, is delivered by trained Peer facilitators to mothers randomized to this arm.

Arm 1: Experimental, intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Mothers and birthing parents who have given birth within 12 months
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (15)

• 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.

  PMID: 3651732 BACKGROUND

• 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.

  PMID: 9881538 BACKGROUND

• 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.

  PMID: 29516342 BACKGROUND

• 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.

  PMID: 26492214 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 4020601 BACKGROUND

• 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.

  PMID: 16673041 BACKGROUND

• 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.

  PMID: 24206185 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 2280326 BACKGROUND

• Hepner KA, Howard S, Paddock SM, et al. A Fidelity Coding guide for a Group Cognitive Behavioral Therapy for Depression: RAND Corporation. 2011

  BACKGROUND

• 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.

  PMID: 21893554 BACKGROUND

• 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.

  PMID: 20013760 BACKGROUND

• Peer Support Integrity, Quality and Impact Survey, 1.1 ed. Centre for Innovation in Peer Support. Hamilton, ON, Canada. April. 2019

  BACKGROUND

• 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.

  PMID: 24341288 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ryan Van Lieshout, MD PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are assigned an identification number and data is de-identified during analysis phase
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 14, 2021
• Study Start: March 28, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)