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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
170
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.
McMaster University
Hamilton, Ontario, Canada
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 9 weeks (post treatment/intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months (durability of intervention effects)
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 6-month (durability of intervention effects)