Online Peer-Delivered Group CBT for PPD

Overview

Women who have recovered from Postpartum Depression and are well now, receive training to teach a 9 week Cognitive Behavioural Therapy (CBT) treatment to women who are feeling depressed after giving birth in the last year. Eligible women are randomly assigned to one of two groups. Women in one group will receive a 9 week group CBT treatment delivered online by the trained Peer Leaders. Women in the other group will not receive the CBT group treatment and will continue to receive treatment as usual or regular care for new mothers. Women in both groups will complete online questionnaires three times – when they start the study, nine weeks later and six months after that. Their information will help determine if the CBT treatment is helpful for postpartum depression.

Full Title of Study: “Online Peer-Delivered Group CBT for Postpartum Depression”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2024

Detailed Description

Women 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+ and living in Hamilton/Brant/Haldimand/Niagara/Halton regions) are screened using the Mini International Neuropsychiatric Interview (MINI). Women free of bipolar, psychotic or current substance use disorders and borderline personality disorder are randomized 1:1 to the experimental (online 9 week peer-delivered CBT program) or control group (treatment as usual, TAU) after providing informed consent. Participants in the Treatment Group receive a 9 week on-line CBT group (2 hrs weekly) delivered by Peer Leaders who are women who have recovered from Postpartum Depression (PPD) and have been trained to deliver CBT. They 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. They 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 their baby). All participants will receive personalized emails with links to their online questionnaires through REDCap at 3 time points (recruitment, nine weeks later and 6 months later). The data from both groups will be examined to determine treatment effects and their durability, respectively.

Interventions

  • Behavioral: Cognitive Behavioural Therapy (CBT)
    • A 9 week CBT group, 2 hours weekly, is delivered by trained Peer Leaders to women randomized to this arm.

Arms, Groups and Cohorts

  • Experimental: Arm 1: Immediate Treatment
    • The immediate treatment 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 treatment group may also receive typical care or treatment as usual for new mothers.
  • No Intervention: Arm 2: Control Group
    • The control group will receive treatment as usual (TAU) or typical care available for postpartum depression in their home communities, via their family doctor, mental health services, midwifery services, etc. Subjects in the control group will receive a list of resources where they may seek treatment and will receive a monthly email encouraging them to seek treatment if their symptoms worsen, including thoughts of self harm or harm to their child. They will also receive a copy of the Canadian Practice Guidelines for the treatment of PPD.

Clinical Trial Outcome Measures

Primary Measures

  • Edinburgh Postnatal Depression Scale (EPDS)
    • Time Frame: 9 weeks
    • 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
  • Edinburgh Postnatal Depression Scale (EPDS)
    • Time Frame: 6 months
    • 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
  • MINI International Neuropsychiatric Interview
    • Time Frame: 9 weeks
    • 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
  • MINI International Neuropsychiatric Interview
    • Time Frame: 6 months
    • 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

Secondary Measures

  • GAD-7
    • Time Frame: 9 weeks
    • The Generalized Anxiety Disorder 7-Item Scale (GAD-7) (32) is a self-report scale that taps generalized anxiety disorder, the most common comorbidity of PPD. Items are scored on a 4-point scale from 0 to 3, with a higher score indicating an increased risk of GAD. A cutoff of ≥11 defines clinically important levels of anxiety symptoms.
  • GAD-7
    • Time Frame: 6 months
    • The Generalized Anxiety Disorder 7-Item Scale (GAD-7) (32) is a self-report scale that taps generalized anxiety disorder, the most common comorbidity of PPD. Items are scored on a 4-point scale from 0 to 3, with a higher score indicating an increased risk of GAD. A cutoff of ≥11 defines clinically important levels of anxiety symptoms.
  • Social Provisions Scale (SPS)
    • Time Frame: 9 weeks
    • A 24-item self-report measure of the degree to which an individual’s social relationships provide support. Items are measured on a 4-point scale (1-4) with total scores ranging from 24-96. Higher scores indicate better perceived social support.
  • Social Provisions Scale (SPS)
    • Time Frame: 6 months
    • A 24-item self-report measure of the degree to which an individual’s social relationships provide support. Items are measured on a 4-point scale (1-4) with total scores ranging from 24-96. Higher scores indicate better perceived social support.
  • Parenting Stress Index (PSI-SF)
    • Time Frame: 9 weeks
    • The Parenting Stress Index (short form) is a 36-item parent self-report measure that identifies potentially dysfunctional parent-child systems on three subscales: parental distress, parent-child dysfunctional interaction, and difficult child. The measure also produces a total score that is an indication of overall level of stress a person is feeling in their role as a parent. Higher scores indicate higher levels of stress.
  • Parenting Stress Index (PSI-SF)
    • Time Frame: 6 months
    • The Parenting Stress Index (short form) is a 36-item parent self-report measure that identifies potentially dysfunctional parent-child systems on three subscales: parental distress, parent-child dysfunctional interaction, and difficult child. The measure also produces a total score that is an indication of overall level of stress a person is feeling in their role as a parent. Higher scores indicate higher levels of stress.
  • The Postpartum Bonding Questionnaire (PBQ)
    • Time Frame: 9 weeks
    • The Postpartum Bonding Questionnaire (PBQ) is a 25-item maternal-report measure that assesses four aspects of maternal-infant relations: (1) bonding, (2) rejection and anger towards the infant, (3) infant-focused anxiety and (4) incipient abuse. Subscales 1-3 will be explored as a continuous outcome using subscale total score. Each item is scored on a scale of 0-5, with higher scores suggestive of more problems. Mother-infant bonding will be measured as a continuous and dichotomous outcome, using cut-off scores for each subscale indicating bonding disorders. Cutoff values of 12 for the bonding subscale, 17 for rejection and anger, and 10 for infant-focused anxiety have been proposed to define bonding disorders in each category.
  • The Postpartum Bonding Questionnaire (PBQ)
    • Time Frame: 6 months
    • The Postpartum Bonding Questionnaire (PBQ) is a 25-item maternal-report measure that assesses four aspects of maternal-infant relations: (1) bonding, (2) rejection and anger towards the infant, (3) infant-focused anxiety and (4) incipient abuse. Subscales 1-3 will be explored as a continuous outcome using subscale total score. Each item is scored on a scale of 0-5, with higher scores suggestive of more problems. Mother-infant bonding will be measured as a continuous and dichotomous outcome, using cut-off scores for each subscale indicating bonding disorders. Cutoff values of 12 for the bonding subscale, 17 for rejection and anger, and 10 for infant-focused anxiety have been proposed to define bonding disorders in each category.
  • Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)
    • Time Frame: 9 weeks
    • The Infant Behaviour Questionnaire-Revised (Very Short Form) (IBQR) is a parent-report measure of infant temperament. The IBQ-R (Very Short Form) consists of 37 items answered on a 7-point scale (1-7) and assesses 3 factors: Positive Affectivity/Surgency with 13 items, Negative Emotionality with 12 items, and Orienting/Regulatory Capacity with 12 items; higher scores indicate greater alignment with the domain.
  • Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)
    • Time Frame: 6 months
    • The Infant Behaviour Questionnaire-Revised (Very Short Form) (IBQR) is a parent-report measure of infant temperament. The IBQ-R (Very Short Form) consists of 37 items answered on a 7-point scale (1-7) and assesses 3 factors: Positive Affectivity/Surgency with 13 items, Negative Emotionality with 12 items, and Orienting/Regulatory Capacity with 12 items; higher scores indicate greater alignment with the domain.
  • Early Child Behavior Questionnaire-Very Short Version
    • Time Frame: 9 weeks
    • The Early Child Behavior Questionnaire (ECBQ) – Very Short Version is a parent report measure of toddler temperament for children aged 18-36 months. The ECBQ (Very Short Form) consists of 36 items answered on a 7 point scale and assesses 3 factors: Effortful Control( 12 items), Surgency (12 items) and Negative Affectivity (12 items). Higher scores indicate greater alignment with the domain.
  • Early Child Behavior Questionnaire-Very Short Version
    • Time Frame: 6 months
    • The Early Child Behavior Questionnaire (ECBQ) – Very Short Version is a parent report measure of toddler temperament for children aged 18-36 months. The ECBQ (Very Short Form) consists of 36 items answered on a 7 point scale and assesses 3 factors: Effortful Control( 12 items), Surgency (12 items) and Negative Affectivity (12 items). Higher scores indicate greater alignment with the domain.
  • Strengths and Difficulties Questionnaire
    • Time Frame: 9 weeks
    • The Strengths and Difficulties Questionnaire (SDQ) is a parent report scale of emotional and behavioral functioning will be used with children aged 24 months and older. The SDQ is a 25 item measure divided into 5 scales – Emotional Symptoms (5 items), Conduct Problems (5 items), Hyperactivity/Attention (5 items), Peer Relationships (5 items) and Prosocial Behaviour (5 items). All scales (excluding Prosocial Behaviour) are summed to generate a total difficulties score.
  • Strengths and Difficulties Questionnaire
    • Time Frame: 6 months
    • The Strengths and Difficulties Questionnaire (SDQ) is a parent report scale of emotional and behavioral functioning will be used with children aged 24 months and older. The SDQ is a 25 item measure divided into 5 scales – Emotional Symptoms (5 items), Conduct Problems (5 items), Hyperactivity/Attention (5 items), Peer Relationships (5 items) and Prosocial Behaviour (5 items). All scales (excluding Prosocial Behaviour) are summed to generate a total difficulties score.
  • EQ-5D-5L
    • Time Frame: 9 weeks
    • A utility-based health-related quality of life self-report instrument consisting of five questions covering mobility, self-care, usual activities, pain/discomfort and depression/anxiety. Quality of Life will be calculated using the Canadian scoring algorithm by multiplying the health utility for the corresponding time period (ie. area under the curve approach).
  • EQ-5D-5L
    • Time Frame: 6 months
    • A utility-based health-related quality of life self-report instrument consisting of five questions covering mobility, self-care, usual activities, pain/discomfort and depression/anxiety. Quality of Life will be calculated using the Canadian scoring algorithm by multiplying the health utility for the corresponding time period (ie. area under the curve approach).
  • Healthcare Resource Utilization Questionnaire
    • Time Frame: 9 weeks
    • Healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period based on the Canadian Community Health Survey and Service Use and Resources Form. Participants will be asked to provide information on health care resource use including diagnoses and procedures, medications, hospital stays, physician and ER visits and the use of all other services (including those relating to mental health). We will measure resources consumed from the perspective of public health care payer and corresponding unit costs will be calculated using provincial billing rates.
  • Healthcare Resource Utilization Questionnaire
    • Time Frame: 6 months
    • Healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period based on the Canadian Community Health Survey and Service Use and Resources Form. Participants will be asked to provide information on health care resource use including diagnoses and procedures, medications, hospital stays, physician and ER visits and the use of all other services (including those relating to mental health). We will measure resources consumed from the perspective of public health care payer and corresponding unit costs will be calculated using provincial billing rates.

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years of age or older – baby under 12 months of age at recruitment – EPDS score 10+ – lives in Brant, Haldimand, Hamilton, Niagara, Halton regions – fluent in written/spoken English Exclusion Criteria:

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

Gender Eligibility: Female

Women who have given birth within 12 months

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McMaster University
  • Collaborator
    • Canadian Institutes of Health Research (CIHR)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ryan Van Lieshout, MD, PhD, Associate Professor – McMaster University
  • Overall Official(s)
    • Ryan Van Lieshout, MD PhD, Principal Investigator, McMaster University
  • Overall Contact(s)
    • Ryan Van Lieshout, MD PhD, (905)522-1155, vanlierj@mcmaster.ca

References

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.

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. Review.

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.

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.

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7.

Loyd BH, Abidin RR. Revision of the Parenting Stress Index. J Pediatr Psychol. 1985 Jun;10(2):169-77.

Brockington IF, Fraser C, Wilson D. The Postpartum Bonding Questionnaire: a validation. Arch Womens Ment Health. 2006 Sep;9(5):233-42. Epub 2006 May 4.

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.

Putnam SP, Rothbart MK. Development of short and very short forms of the Children's Behavior Questionnaire. J Pers Assess. 2006 Aug;87(1):102-12.

Bourdon KH, Goodman R, Rae DS, Simpson G, Koretz DS. The Strengths and Difficulties Questionnaire: U.S. normative data and psychometric properties. J Am Acad Child Adolesc Psychiatry. 2005 Jun;44(6):557-64.

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