Online Peer-Delivered Group CBT for PPD

Postpartum Depression Clinical Trial

Official title:

Online Peer-Delivered Group CBT for Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05044455
• Other study ID #: OnlinePeerCBT
• Status: Completed
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

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

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (15)

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. — View 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

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. — View 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. — View Citation

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

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. — View 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. — View 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. — View 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. — View Citation

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

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. — View 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. — View 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. — View 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. — View Citation

Zimet GD, Dahlem NW, Zimet SG, et al. The multidimensional scale of perceived social support. Journal of Personality Assessment. 1988;52(1):30-41. doi:10.1207/s15327752jpa5201_2

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Client Satisfaction Questionnaire (CSQ-8)	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.	9 weeks
Other	CBT Skills Questionnaire (CBTSQ)	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 weeks
Other	CBT Skills Questionnaire (CBTSQ)	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.	9 weeks
Other	Working Alliance Inventory (WAI-SR)	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.	4 weeks
Other	Working Alliance Inventory (WAI-SR)	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.	9 weeks
Other	Peer Support Integrity, Quality and Impact Survey (PSIQI)	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.	4 weeks
Other	Peer Support Integrity, Quality and Impact Survey (PSIQI)	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.	9 weeks
Other	Therapeutic Factors Inventory 8 (TFI-8)	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.	4 weeks
Other	Therapeutic Factors Inventory 8 (TFI-8)	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 weeks
Other	Adherence Checklist	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	Weekly, weeks 1 through 9 of intervention
Other	Competence Checklist	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.	Weekly, weeks 1 through 9 of intervention
Primary	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
Primary	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
Primary	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
Primary	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	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.	9 weeks
Secondary	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.	6 months
Secondary	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.	9 weeks
Secondary	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.	6 months
Secondary	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.	9 weeks
Secondary	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.	6 months
Secondary	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.	9 weeks
Secondary	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.	6 months
Secondary	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).	9 weeks
Secondary	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).	6 months
Secondary	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.	9 weeks
Secondary	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.	6 months