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| Name | Class |
|---|---|
| Niagara Region Public Health | OTHER |
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The purpose of this study is to determine the effectiveness of an online 9-week group Cognitive Behavioural Therapy (CBT; a type of talking therapy) intervention that is co-led by public health nurses (PHNs) and individuals who have previously recovered (i.e., lay peers) from postpartum depression (PPD) for treating PPD when delivered in addition to treatment as usual (TAU) compared to TAU alone. The study will also assess the impact of the intervention on common comorbidities (anxiety) and complications (parenting stress, mother-infant relationship, social support, and infant temperament) of PPD and whether it is cost-effective.
The primary objective of the Randomized Controlled Trial (RCT) is to determine if a 9-week group Cognitive Behavioral Therapy (CBT) intervention delivered online and co-led by public health nurses (PHNs) and peers added to treatment as usual (TAU) can improve postpartum depression (PPD) more than TAU alone. Peers are individuals who have previously recovered from PPD and received training to deliver the intervention. The secondary objective of the RCT is to determine if the intervention can effectively treat its common comorbidities (anxiety) and complications (parenting stress, social support, mother-infant relationship, and infant temperament) and whether the intervention is cost-effective. 170 mothers/birthing parents will take part in the study with 50% being randomly assigned to the intervention group. All participants complete online questionnaires at 3 time points: baseline (T1), 9 weeks later (T2-immediately post-intervention in the experimental group to assess effectiveness) and 6 months later (T3-intervention durability).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online CBT Group | Experimental | Participants randomized to the Intervention group will attend a 9-week online CBT group co-led by a Public Health Nurse and a Peer (individual who has recovered from PPD and received training to deliver the intervention) in addition to receiving usual care. |
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| Treatment as Usual | No Intervention | Participants randomized to the No Intervention group will continue to receive treatment as usual (standard postnatal care). A list of resources will be emailed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Postpartum Depression (PPD) | Behavioral | Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). The intervention consists of 9- 2hr sessions, the first half involves teaching and practice of CBT skills (cognitive restructuring, thinking errors, problem solving etc) followed by one hour of unstructured discussion around topics relevant to participants with Postpartum Depression (PPD) (sleep, supports, transitions, etc). Each group will be delivered by one randomly selected PHN and one randomly selected peer using our intervention manual. |
| Measure | Description | Time Frame |
|---|---|---|
| Postpartum Depression | PPD is best conceptualized as a continuous construct with its impact operating across a continuum of severity. The primary outcome is change in PPD symptoms at 9 weeks (i.e., immediately post-treatment). This will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a gold standard measure of PPD symptoms used commonly in research and clinical settings. The EPDS has 10 items scored on a scale 0-3. Scores range from 0-30, with higher scores indicating more severe depression symptoms. The EPDS will be examined as a continuous outcome. Changes in score of 4 or more points is considered clinically meaningful improvement. | 9 weeks (post treatment/intervention) |
| Major Depressive Disorder | We will compare DSM-5-defined major depressive disorder (MDD) using the Mini International Neuropsychiatric Interview (MINI). This interview will be administered by telephone at T2-T3. Symptoms must be present every day or nearly every day for a period of at least 2 weeks and include at least one of: depressed mood most of the day, markedly diminished interest or pleasure in all or almost all activities. There must be a total of five symptoms including the previous two criteria and the following five criteria: significant unintentional weight change or appetite change; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue; feelings of worthlessness or inappropriate or excessive guilt; decreased ability to concentrate or make decisions; recurrent thoughts of death or suicidal ideation. | 9 weeks (post treatment/intervention) |
| Major Depressive Disorder | We will compare DSM-5-defined major depressive disorder (MDD) using the Mini International Neuropsychiatric Interview (MINI). This interview will be administered by telephone at T2-T3. Symptoms must be present every day or nearly every day for a period of at least 2 weeks and include at least one of: depressed mood most of the day, markedly diminished interest or pleasure in all or almost all activities. There must be a total of five symptoms including the previous two criteria and the following five criteria: significant unintentional weight change or appetite change; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue; feelings of worthlessness or inappropriate or excessive guilt; decreased ability to concentrate or make decisions; recurrent thoughts of death or suicidal ideation. |
| Measure | Description | Time Frame |
|---|---|---|
| Parenting Stress | The PSI-SF (Parenting Stress Index-Short Form ) is a 36-item self-scoring measure of parenting stress. It has 3 subscales: Parental distress, parent-child dysfunctional interaction and difficult child. Items are scored on a 5-point Likert scale. Higher scores indicate higher parental stress. | 9 weeks (post treatment/intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity of Intervention Delivery | The fidelity with which the PHN/Peers deliver the 9-week CBT intervention will be assessed using measures of adherence and competence that were developed for evaluating delivery of the 9-week CBT groups. Each of the weekly CBT groups will be digitally recorded and trained raters will rate the adherence to the intervention model and competence with which the PHN/Peers deliver the intervention. |
Inclusion Criteria:
Mothers or birthing parents, 18 years old, have an infant under 12 months of age at recruitment, fluent in written/spoken English, have a Edinburgh Postnatal Depression Scale (EPDS) score ≥10 and live in Ontario, Canada.
Exclusion Criteria:
Bipolar, psychotic, or current substance use disorders and borderline personality disorder as assessed during screening when study coordinator administers the Mini International Neuropsychiatric Interview (MINI).
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| Name | Affiliation | Role |
|---|---|---|
| Ryan J Van Lieshout, MD, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8S 4L8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16260528 | Background | Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db. | |
| 21569372 | Background | Lanes A, Kuk JL, Tamim H. Prevalence and characteristics of postpartum depression symptomatology among Canadian women: a cross-sectional study. BMC Public Health. 2011 May 11;11:302. doi: 10.1186/1471-2458-11-302. |
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No individual participant data will be available to other researchers
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Participants who have met the eligibility requirements and signed the consent form are randomized and allocated in a 1:1 ratio to one of two groups: Intervention (those who participate in the 9-week CBT group along with treatment as usual) and Control (continue with treatment as usual alone). Control group participants receive a list of mental health resources. Both groups complete online questionnaires at 3 timepoints: enrollment (T1), 9 weeks later (T2-post intervention for those in the intervention group) and 6 months later (T3).
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Data analysts will be blinded. Data is deidentified and a study ID number is assigned. Research assistants following up with T2 and T3 questionnaires and phone interviews will be blinded.
|
| 6 months (durability of intervention effects) |
| Postpartum Depression | PPD is best conceptualized as a continuous construct with its impact operating across a continuum of severity. The primary outcome is change in PPD symptoms 6 months later (i.e., to assess durability of intervention effects). This will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a gold standard measure of PPD symptoms used commonly in research and clinical settings. The EPDS has 10 items scored on a scale 0-3. Scores range from 0-30, with higher scores indicating more severe depression symptoms. The EPDS will be examined as a continuous outcome. Changes in score of 4 or more points is considered clinically meaningful improvement. | 6 months (durability of intervention effects) |
| Parenting Stress | The PSI-SF (Parenting Stress Index-Short Form ) is a 36-item self-scoring measure of parenting stress. It has 3 subscales: Parental distress, parent-child dysfunctional interaction and difficult child. Items are scored on a 5-point Likert scale. Higher scores indicate higher parental stress. | 6 months (durability of intervention effects) |
| 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 diagnosis and procedures, medications, hospital stays, physician and ER visits and the use of all other services (including those related 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 (post treatment/intervention) |
| 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 diagnosis and procedures, medications, hospital stays, physician and ER visits and the use of all other services (including those related 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 (durability of intervention effects) |
| Other Psychiatric Disorders | The Mini International Neuropsychiatric Interview (MINI) will be administered at T2 and T3 to provide information on the presence or absence of the major Axis 1 psychiatric disorders in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM 5) at these time points. This will be administered by phone by a research assistant and will include the following modules: Major Depressive Episode; Major Depressive Disorder; Panic Disorder; Agoraphobia; Social Anxiety Disorder (Social Phobia); Obsessive-Compulsive Disorder; Posttraumatic Stress Disorder; Alcohol Use Disorder; Substance Use Disorder (Non-alcohol); Generalized Anxiety Disorder with extra screening questions for Psychosis. | 9 weeks (post treatment/intervention) |
| Other Psychiatric Disorders | The Mini International Neuropsychiatric Interview (MINI) will be administered at T2 and T3 to provide information on the presence or absence of the major Axis 1 psychiatric disorders in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM 5) at these time points. This will be administered by phone by a research assistant and will include the following modules: Major Depressive Episode; Major Depressive Disorder; Panic Disorder; Agoraphobia; Social Anxiety Disorder (Social Phobia); Obsessive-Compulsive Disorder; Posttraumatic Stress Disorder; Alcohol Use Disorder; Substance Use Disorder (Non-alcohol); Generalized Anxiety Disorder with extra screening questions for Psychosis. | 6 months (durability of intervention effects) |
| Postpartum Anxiety | The GAD-7 (General Anxiety Disorder-7) is a reliable and valid 7-item self-report scale that assesses the symptoms of generalized anxiety disorder, the most common PPD comorbidity. Total score for the seven items ranges from 0-21 with a higher score indicating more severe anxiety symptoms. | 9 weeks (post treatment/intervention) |
| Postpartum Anxiety | The GAD-7 (General Anxiety Disorder-7) is a reliable and valid 7-item self-report scale that assesses the symptoms of generalized anxiety disorder, the most common PPD comorbidity. Total score for the seven items ranges from 0-21 with a higher score indicating more severe anxiety symptoms. | 6 months (durability of intervention effects) |
| Social Support | The MSPSS (Multidimensional Scale of Perceived Social Support) is a 12-item self-report scale designed to measure perceived social support from three sources: family, friends and partner. Each item is rated 1-7 with 1 very strongly disagree and 7 very strongly agree. Higher scores could be considered as having higher levels of support. | 9 weeks (post treatment/intervention) |
| Social Support | The MSPSS (Multidimensional Scale of Perceived Social Support) is a 12-item self-report scale designed to measure perceived social support from three sources: family, friends and partner. Each item is rated 1-7 with 1 very strongly disagree and 7 very strongly agree. Higher scores could be considered as having higher levels of support. | 6 months (durability of intervention effects) |
| Infant Temperament | The Infant Behavior Questionnaire - Revised (Very Short Form) 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 assess 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 (durability of intervention effects) |
| Infant Temperament | The Infant Behavior Questionnaire - Revised (Very Short Form) 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 assess 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 (post treatment/intervention) |
| Mother-Infant Relationship | The PBQ (Postpartum Bonding Questionnaire) 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. Respondents respond to each statement based on a 6-point scale, with total scale scores ranging from 0-125, with a higher cumulative score indicating more severe bonding disturbances. 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 indicting 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 (post treatment/intervention) |
| Mother-Infant Relationship | The PBQ (Postpartum Bonding Questionnaire) 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. Respondents respond to each statement based on a 6-point scale, with total scale scores ranging from 0-125, with a higher cumulative score indicating more severe bonding disturbances. 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 indicting 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 (durability of intervention effects) |
| Postpartum Anxiety | Postpartum Anxiety as a maternal comorbidity is a secondary outcome measure and the DSM-5 defined generalized anxiety disorder (GAD) will be compared using the Mini International Neuropsychiatric Interview (MINI). The GAD module will be part of the full MINI administered during screening and then administered again at T2 and T3 by phone by a research assistant. Excessive worry/anxiety about several routine things must be present most days in the preceding 6 months, anxiety/worry must be difficult to control as well as significantly disrupt social, work or relationship functions or cause significant distress. In order to meet the criteria for a Generalized Anxiety Disorder (current) to be present, three or more of the following must also be present in previous 6 months in addition to the previous three criteria: feel restless, keyed up or on edge; muscle tension; difficulties concentrating; irritability; sleep difficulties. | 9 weeks (post treatment/intervention) |
| Postpartum Anxiety | Postpartum Anxiety as a maternal comorbidity is a secondary outcome measure and the DSM-5 defined generalized anxiety disorder (GAD) will be compared using the Mini International Neuropsychiatric Interview (MINI). The GAD module will be part of the full MINI administered during screening and then administered again at T2 and T3 by phone by a research assistant. Excessive worry/anxiety about several routine things must be present most days in the preceding 6 months, anxiety/worry must be difficult to control as well as significantly disrupt social, work or relationship functions or cause significant distress. In order to meet the criteria for a Generalized Anxiety Disorder (current) to be present, three or more of the following must also be present in previous 6 months in addition to the previous three criteria: feel restless, keyed up or on edge; muscle tension; difficulties concentrating; irritability; sleep difficulties. | 6 months (durability of intervention effects) |
| EQ-5D-5L | A utility-based health-related quality of life self-report instrument consisting of five questions (scale of 1-5) covering mobility, self-care, usual activities, pain/discomfort and depression/anxiety. Lower scores indicate less problems. 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-week (post treatment/intervention) |
| EQ-5D-5L | A utility-based health-related quality of life self-report instrument consisting of five questions (scale of 1-5) covering mobility, self-care, usual activities, pain/discomfort and depression/anxiety. Lower scores indicate less problems. 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-month (durability of intervention effects) |
| Weekly during the 9-week intervention |
| Assess Participant Satisfaction | The Client Satisfaction Questionnaire-8 (CSQ-8) is an 8-item measure 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. This will only be completed by participants who complete the 9-week CBT group, immediately after they participate in the intervention. | 9-week (post treatment/intervention) |
| Psychotherapy Experience | Study participants will complete this questionnaire at T2 (past 9 weeks) and T3 (past 6 months) answering questions if they received any type of talking therapy or psychotherapy (ie. Cognitive Behavioural Therapy, Group Therapy) other than the group CBT sessions they may have attended as part of the research study. The questions ask about type of therapy received, why it was received, the number of sessions received and the date started and stopped. This information will be used as part of the sub-group analysis to examine the impact of other therapies on the intervention effectiveness. | 9 weeks (post treatment/intervention) |
| Psychotherapy Experience | Study participants will complete this questionnaire at T2 (past 9 weeks) and T3 (past 6 months) answering questions if they received any type of talking therapy or psychotherapy (ie. Cognitive Behavioural Therapy, Group Therapy) other than the group CBT sessions they may have attended as part of the research study. The questions ask about type of therapy received, why it was received, the number of sessions received and the date started and stopped. This information will be used as part of the sub-group analysis to examine the impact of other therapies on the intervention effectiveness. | 6 months (durability of intervention effects) |
| Personal Attributes | A 24-item self-report measure of gender identity. We will examine the moderating effect of its instrumentality and expressivity scales, as well as self-identified gender identity on our outcomes | 9 weeks (post treatment/intervention) |
| Personal Attributes | A 24-item self-report measure of gender identity. We will examine the moderating effect of its instrumentality and expressivity scales, as well as self-identified gender identity on our outcomes | 6 months (durability of intervention effects) |
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |