Online 1-Day CBT-Based Workshops for Preventing Postpartum Depression
Study Details
Study Description
Brief Summary
To conduct a randomized controlled trial (n=410) examining the impact of an online cognitive behavioural therapy (CBT)-based workshop on rates of postpartum depression (PPD) when added to treatment as usual (TAU)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Postpartum depression affects up to 1 in 5 mothers, however just 15% receive evidence-based treatment. It is associated with negative consequences for women and their families with enormous costs to the healthcare system. Postpartum depression is an ideal candidate for prevention because it is common, the window of opportunity to intervene is clear (pregnancy), and its risk factors are well-established and easily identifiable. Furthermore, women are in frequent contact with the healthcare system during pregnancy and are more motivated to improve their health during this time than at any other time in their lives. Given high rates of PPD and its adverse effects on mothers and their families, and the relative lack of efficient, effective psychotherapeutic interventions for preventing PPD, safe, novel, and efficient preventive interventions are needed. Since large 1-day workshops appear to successfully treat depression, given the widespread interest and investment of public health units across Canada in maternal and child health, Online 1-Day CBT-Based Workshops for Preventing PPD should be developed and tested for their ability to prevent PPD in Canadian women.
Based on longstanding clinical work with women at high risk for PPD, the development of a successful 1-Day CBT-Based Treatment Workshop for PPD and its delivery in-person and online, and an extensive review of the PPD prevention literature, the investigators developed the content for our prevention workshop as well as an accompanying script and intervention manual for participants in a previous pilot study. This pilot study also assessed feasibility by recruiting 32 women who took part in an online CBT-based workshop and provided feedback on its content, delivery and assessment procedures. The workshop, manual, and study protocol were subsequently refined and our experience recruiting participants in community settings into CBT treatment studies for PPD will be utilized in the current randomized controlled trial (n=410), which is aimed as assessing the effectiveness of these workshops at reducing the likelihood of developing PPD in women at risk.
Objectives of the proposed randomized controlled trial are as follows:
Primary: Can Online 1-Day CBT-Based Workshops delivered to women and other pregnant persons at increased risk for PPD and added to TAU reduce rates of PPD more than TAU alone?
Secondary: Are online 1-Day CBT-Based Workshops for preventing PPD cost-effective?
Tertiary: Can these workshops reduce the risk of developing the common comorbidities and complications of PPD (maternal anxiety, problems with the mother-infant relationship, infant temperament, maternal social support, and maternal perceived stress).
A prospective randomized controlled trial design will be used to address these objectives. The study will be advertised through our public health and community partners in Ontario, as well as on Facebook/Instagram using Facebook advertising in the province. Participants will be allocated in a 1:1 ratio to experimental (1-Day CBT Workshop in addition to TAU) or control (TAU alone) groups. Both experimental and control groups will complete data collection at baseline (before completing the 1-Day CBT workshop for experimental group participants), and at 1, 2 and 3 months postpartum.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Online 1-Day CBT-Based Workshop Participants assigned to the treatment arm will attend a day long CBT-based workshop delivered online by two trained facilitators in addition to receiving usual care. |
Behavioral: Online 1-Day Cognitive Behavioural Therapy-Based Workshop
The Online Workshop is a day-long intervention delivered by two trained facilitators (i.e., registered psychotherapists, social workers, registered nurses, and/or a psychiatrist) consisting of 6 hours of instruction delivered in 4 modules. The 1st contains information on PPD etiology with a focus on modifiable cognitive risk factors (e.g., negative thoughts, maladaptive core beliefs). The 2nd module focuses on cognitive skills including cognitive restructuring. The 3rd builds behavioural skills such as problem solving, behavioural activation, assertiveness, sleep strategies, and using supports. The final module provides an opportunity for goal setting/action planning. Teaching methods include didactic sections, group exercises, and role-plays. Regular breaks are incorporated. Each participant is given a professionally designed manual to facilitate learning. We also provide a list of region-specific PPD resources and a copy of the Canadian Practice Guidelines for the treatment of PPD.
|
| No Intervention: Treatment as Usual Participants assigned to the control arm will continue to receive standard prenatal care from their healthcare providers. |
Outcome Measures
Primary Outcome Measures
- Change from Absence of Major Depressive Episode to Presence of Major Depressive Episode (MINI International Neuropsychiatric Interview (MINI) - Major Depressive Disorder Module) [1, 2, and 3 months postpartum]
The MINI is a brief, validated, structured diagnostic interview that is used widely in research and clinical settings to identify psychiatric disorders consistent with the DSM-5.20 The Major Depressive Disorders Module takes approximately 5 minutes to administer and provides a dichotomous result: presence or absence of current major depressive disorder. The MINI - Major Depressive Disorder Module will be used to measure whether there is a change in mood from baseline (i.e., absence of a current major depressive episode to presence of a major depressive episode).
- Change from Absence of Major Depressive Episode to Presence of Major Depressive Episode (The Edinburgh Postnatal Depression Scale (EPDS)) [1, 2, and 3 months postpartum]
The Edinburgh Postnatal Depression Scale (EPDS) is a 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. Change from baseline scores will be measured.
Secondary Outcome Measures
- Cost of Resources Used Over the Trial Period [6 months]
Healthcare resource utilization data (including mental health service use) will be collected using a questionnaire based on the Canadian Community Health Survey and the Service Use and Resources Form, adapted for the postpartum period and used in previous PPD research. We will measure resources consumed over the trial period from the perspective of public health care payer. Corresponding unit costs will be calculated using provincial or other standard billing rates. Participants will provide information on resource use including diagnoses, procedures, medications, hospital stays, physician and ER visits, and use of other healthcare providers.
- Quality-Adjusted Life Year (QALY) (EQ-5D-5L) [6 months]
EQ-5D-5L is a utility-based health-related quality of life instrument consisting of five questions covering depression/anxiety, usual activities, self-care, pain/ discomfort, and mobility. Its Canadian scoring algorithm will be used to convert the five responses to health utility at baseline, and one, two, and three months postpartum. For each participant, a QALY will be calculated by multiplying the health utility for the matching time period (i.e., the area under the curve approach).
- Generalized Anxiety Disorder (MINI International Neuropsychiatric Interview (MINI) - Generalized Anxiety Disorder Module) [1, 2, and 3 months postpartum]
The MINI is a brief, validated, structured diagnostic interview that is used widely in research and clinical settings to identify psychiatric disorders consistent with the DSM-5.20 The Generalized Anxiety Disorder Module takes approximately 5 minutes to administer and provides a dichotomous result: presence or absence of current generalized anxiety disorder.
- Generalized Anxiety Disorder 7-Item Scale (GAD-7) [1, 2, and 3 months postpartum]
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a validated 7-item self-report scale that identifies probable cases of generalized anxiety disorder (GAD) and severity of anxiety symptoms, the most common PPD comorbidity that is known to be responsive to CBT. Respondents rate how often they have been bothered by various symptoms by providing a score on a 4-point Likert scale ranging from 'not at all' to 'nearly every day'. A higher score on this scale indicates greater severity of anxiety.
- Multidimensional Scale of Perceived Social Support (MSPSS) [1, 2, and 3 months postpartum]
The MSPSS is a 12-item measure of perceived adequacy of social support from three sources: friends, family and significant other. It is scored using a 5-point Likert scale (0=strongly disagree, 5=strongly agree). Higher scores indicated higher perceived adequacy of social support.
- Stress (Perceived Stress Scale (PSS)) [1, 2, and 3 months postpartum]
The Perceived Stress Scale (PSS) is one of the most widely used psychological instruments for measuring the perception of stress. The PSS measures the degree to which situations are appraised as stressful and items tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The questions in this scale ask about feelings and thoughts experienced during the last month, and respondents are asked to indicate how often they felt or thought a certain way on a 5-point Likert scale ranging from 0=never to 4=very often. Scores range from 0 to 40 with scores between 0-13 considered low stress, 14-26 considered moderate stress, and 27-40 considered high perceived stress.
- Mother-Infant Relationship (Postpartum Bonding Questionnaire (PBQ)) [1, 2, and 3 months postpartum]
The Postpartum Bonding Questionnaire (PBQ) is a 25-item maternal-report scale that detects disorders of the mother-infant relationship. The PBQ measures mother-infant attachment on four subscales: (1) bonding, (2) rejection & pathological anger, (3) infant-focused anxiety, and (4) incipient abuse.
- Infant Temperament (Infant Behaviour Questionnaire-Revised Very Short Form (IBQ-R)) [1, 2, and 3 months postpartum]
The IBQ-R is a 37-item self-report, gold-standard measure of infant temperament. This measure is completed by mothers who report in their infants behaviour and temperament. How often a mother observes each behaviour in a week is measured on 7-point scale from 1 (never) to 7 (always). This scale assesses temperament on 3 subscales: effortful control (ability to regulate themselves), negative affect and surgency (positive emotion).
Other Outcome Measures
- Client Satisfaction (Client Satisfaction Questionnaire (CSQ-8)) [1 week post-intervention in the experimental arm]
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.
- Client Satisfaction (Client Satisfaction Questionnaire (CSQ-8)) [3 months postpartum]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older
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City of residence in Ontario, Canada
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Currently in 3rd trimester of pregnancy (between 28-36 weeks gestation)
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Do not meet diagnostic criteria for a current major depressive episode (determined using the Mini International Neuropsychiatric Interview (MINI))
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Presence of one or more risk factors for PPD, and/or a score ≥23 on the Antenatal (Psychosocial) Risk Questionnaire (ANRQ).
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Risk factors include:
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Low SES (Canadian Household Low Income Cut-Off (LICOs) Before Tax)
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past history of depression or generalized anxiety disorder (Mini International Neuropsychiatric Interview (MINI))
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major life stress in the past 12 months (e.g., job loss, separation, bereavement)
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single marital status
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a history of physical or sexual abuse
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perceived low social support.
Exclusion Criteria:
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meeting diagnostic criteria for a current major depressive episode (determined using the Mini International Neuropsychiatric Interview; MINI)
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current or past bipolar, psychotic, or current substance use disorders (determined using the Mini International Neuropsychiatric Interview; MINI)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McMaster University | Hamilton | Ontario | Canada | L8S 4L8 |
Sponsors and Collaborators
- McMaster University
Investigators
- Principal Investigator: Ryan J Van Lieshout, MD, PhD, McMaster University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RCT1-day CBT to prevent PPD