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Completed

NCT Number: NCT05044455

Online Peer-Delivered Group CBT for PPD

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.

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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 outcomes

  1. 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.

  2. 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.

  3. Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: 9 weeks

    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.

  4. Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: 6 months

    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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

  11. 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). 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.

  12. 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). 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.

Other outcomes

  1. Client Satisfaction Questionnaire (CSQ-8)

    Time frame: 9 weeks

    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.

  2. CBT Skills Questionnaire (CBTSQ)

    Time frame: 4 weeks

    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.

  3. CBT Skills Questionnaire (CBTSQ)

    Time frame: 9 weeks

    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.

  4. Working Alliance Inventory (WAI-SR)

    Time frame: 4 weeks

    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.

  5. Working Alliance Inventory (WAI-SR)

    Time frame: 9 weeks

    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.

  6. Peer Support Integrity, Quality and Impact Survey (PSIQI)

    Time frame: 4 weeks

    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.

  7. Peer Support Integrity, Quality and Impact Survey (PSIQI)

    Time frame: 9 weeks

    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.

  8. Therapeutic Factors Inventory 8 (TFI-8)

    Time frame: 4 weeks

    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.

  9. Therapeutic Factors Inventory 8 (TFI-8)

    Time frame: 9 weeks

    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.

  10. Adherence Checklist

    Time frame: Weekly, weeks 1 through 9 of intervention

    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

  11. Competence Checklist

    Time frame: Weekly, weeks 1 through 9 of intervention

    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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Online Peer-Delivered Group CBT for Postpartum Depression

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2021
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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