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Online Peer-Delivered Group CBT for PPD

Primary Purpose

Postpartum Depression

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy (CBT)
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring CBT, Postpartum Depression

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1: Experimental, intervention

Arm 2: Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

GAD-7
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
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.
Multidimensional Scale of Perceived Social Support (MSPSS)
A 12-item scale designed to measure perceived social support from three sources: (1) family, (2) friends and (3) significant other. Items are scored on a 7-point scale, and total scores range from 12-84 with higher scores indicating a higher level of perceived social support. A score of 12-35 indicates low perceived social support, 36-60 indicates medium perceived social support and 61-84 indicates high perceived social support.
Multidimensional Scale of Perceived Social Support (MSPSS)
A 12-item scale designed to measure perceived social support from three sources: (1) family, (2) friends and (3) significant other. Items are scored on a 7-point scale, and total scores range from 12-84 with higher scores indicating a higher level of perceived social support. A score of 12-35 indicates low perceived social support, 36-60 indicates medium perceived social support and 61-84 indicates high perceived social support.
The Postpartum Bonding Questionnaire (PBQ)
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)
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)
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)
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.
EQ-5D-5L
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
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
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). The investigators 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
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). The investigators will measure resources consumed from the perspective of public health care payer and corresponding unit costs will be calculated using provincial billing rates.

Full Information

First Posted
September 2, 2021
Last Updated
April 5, 2023
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05044455
Brief Title
Online Peer-Delivered Group CBT for PPD
Official Title
Online Peer-Delivered Group CBT for Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
CBT, Postpartum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
Participants are assigned an identification number and data is de-identified during analysis phase
Allocation
Randomized
Enrollment
167 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Experimental, intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2: Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy (CBT)
Intervention Description
A 9 week CBT group, 2 hours weekly, is delivered by trained Peer facilitators to mothers randomized to this arm.
Primary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
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
Time Frame
9 weeks
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
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
Time Frame
6 months
Title
MINI International Neuropsychiatric Interview
Description
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
Time Frame
9 weeks
Title
MINI International Neuropsychiatric Interview
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
GAD-7
Description
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.
Time Frame
9 weeks
Title
GAD-7
Description
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.
Time Frame
6 months
Title
Multidimensional Scale of Perceived Social Support (MSPSS)
Description
A 12-item scale designed to measure perceived social support from three sources: (1) family, (2) friends and (3) significant other. Items are scored on a 7-point scale, and total scores range from 12-84 with higher scores indicating a higher level of perceived social support. A score of 12-35 indicates low perceived social support, 36-60 indicates medium perceived social support and 61-84 indicates high perceived social support.
Time Frame
9 weeks
Title
Multidimensional Scale of Perceived Social Support (MSPSS)
Description
A 12-item scale designed to measure perceived social support from three sources: (1) family, (2) friends and (3) significant other. Items are scored on a 7-point scale, and total scores range from 12-84 with higher scores indicating a higher level of perceived social support. A score of 12-35 indicates low perceived social support, 36-60 indicates medium perceived social support and 61-84 indicates high perceived social support.
Time Frame
6 months
Title
The Postpartum Bonding Questionnaire (PBQ)
Description
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.
Time Frame
9 weeks
Title
The Postpartum Bonding Questionnaire (PBQ)
Description
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.
Time Frame
6 months
Title
Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)
Description
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.
Time Frame
9 weeks
Title
Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)
Description
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.
Time Frame
6 months
Title
EQ-5D-5L
Description
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).
Time Frame
9 weeks
Title
EQ-5D-5L
Description
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).
Time Frame
6 months
Title
Healthcare Resource Utilization Questionnaire
Description
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). The investigators will measure resources consumed from the perspective of public health care payer and corresponding unit costs will be calculated using provincial billing rates.
Time Frame
9 weeks
Title
Healthcare Resource Utilization Questionnaire
Description
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). The investigators will measure resources consumed from the perspective of public health care payer and corresponding unit costs will be calculated using provincial billing rates.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
Intervention participants only. An 8-item scale that measures and assesses consumer satisfaction with health and human services. Items are scored on a 4-point scale and total scores range from 8-32, with higher scores indicating greater satisfaction.
Time Frame
9 weeks
Title
CBT Skills Questionnaire (CBTSQ)
Description
Intervention participants only. A 16-item maternal-report measure designed to assess cognitive and behavioural skills acquisition. Each item is scored on a 5-point scale, and total scores range from 16-80. Higher cognitive restructuring and behavioural activation scores predict reduction of overall psychiatric symptoms and depression.
Time Frame
4 weeks
Title
CBT Skills Questionnaire (CBTSQ)
Description
Intervention participants only. A 16-item maternal-report measure designed to assess cognitive and behavioural skills acquisition. Each item is scored on a 5-point scale, and total scores range from 16-80. Higher cognitive restructuring and behavioural activation scores predict reduction of overall psychiatric symptoms and depression.
Time Frame
9 weeks
Title
Working Alliance Inventory (WAI-SR)
Description
Intervention participants only. A 12-item maternal-report measure that assesses three aspects of therapeutic alliance:(1) agreement on the tasks of therapy, (2) agreement on the goals of therapy and (3) development of an affective bond. Items are rated on a 5-point scale, and total scores range from 12-60 with higher scores indicating a better therapeutic alliance.
Time Frame
4 weeks
Title
Working Alliance Inventory (WAI-SR)
Description
Intervention participants only. A 12-item maternal-report measure that assesses three aspects of therapeutic alliance:(1) agreement on the tasks of therapy, (2) agreement on the goals of therapy and (3) development of an affective bond. Items are rated on a 5-point scale, and total scores range from 12-60 with higher scores indicating a better therapeutic alliance.
Time Frame
9 weeks
Title
Peer Support Integrity, Quality and Impact Survey (PSIQI)
Description
Intervention participants only. A 4-scale maternal-report measure used to evaluate therapy quality. Subscale 1 will be explored which includes 17 statements about possible actions and behaviours of a peer support worker. Items are scored on a 5 point-scale, with "not applicable" available as a sixth option (this score is excluded when total score is calculated). The score range for Subscale 1 is 17-85 with a higher score indicating more positive feelings about the therapist's integrity.
Time Frame
4 weeks
Title
Peer Support Integrity, Quality and Impact Survey (PSIQI)
Description
Intervention participants only. A 4-scale maternal-report measure used to evaluate therapy quality. Subscale 1 will be explored which includes 17 statements about possible actions and behaviours of a peer support worker. Items are scored on a 5 point-scale, with "not applicable" available as a sixth option (this score is excluded when total score is calculated). The score range for Subscale 1 is 17-85 with a higher score indicating more positive feelings about the therapist's integrity.
Time Frame
9 weeks
Title
Therapeutic Factors Inventory 8 (TFI-8)
Description
An 8-item self-report measure that assesses individuals' perception of four therapeutic factors in group settings: (1) instillation of hope, (2) secure emotional expression, (3) awareness of relational impact, and (4) social learning.
Time Frame
4 weeks
Title
Therapeutic Factors Inventory 8 (TFI-8)
Description
An 8-item self-report measure that assesses individuals' perception of four therapeutic factors in group settings: (1) instillation of hope, (2) secure emotional expression, (3) awareness of relational impact, and (4) social learning.
Time Frame
9 weeks
Title
Adherence Checklist
Description
9 individual checklists that measure the degree to which a peer leader is consistent with the intervention manual when applying techniques. The nine sessions vary in content, so this scale consists of different items for each session and assesses topics including agenda setting, content delivery, and homework review. Individual items are rated on a 3-4-point Likert scale ranging from 0 (not covered at all) to 3 (or 4) thorough coverage. Total adherence scores range from 15 (session 4, 6, 9) to 31 (session 1). These checklists are used by the peers, expert therapist (psychiatrist) and a graduate student
Time Frame
Weekly, weeks 1 through 9 of intervention
Title
Competence Checklist
Description
This one checklist measures the level of skill and judgement that a peer leader demonstrates when delivering the intervention. This scale assesses structure and use of time, genuineness, empathy, collaboration, guided discovery, group participation, and eliciting emotional expression. Competence scores range from 0-42 with a higher score indicating greater competence.
Time Frame
Weekly, weeks 1 through 9 of intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Mothers and birthing parents who have given birth within 12 months
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Van Lieshout, MD PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
Peer Support Integrity, Quality and Impact Survey, 1.1 ed. Centre for Innovation in Peer Support. Hamilton, ON, Canada. April. 2019
Results Reference
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PubMed Identifier
24341288
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.
Results Reference
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Online Peer-Delivered Group CBT for PPD

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