- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03654261
1-Day CBT Workshops for PPD
1-Day Cognitive Behavioural Therapy Workshops for Postpartum Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families (1,2). Indeed, the cost of one case of PPD is estimated to exceed $150,000 (3). Unfortunately, fewer than 15% of women with PPD receive evidence-based care (4), which is at least partly due to difficulties accessing treatment, particularly therapies that are most preferred (e.g., psychotherapy (5)).
Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment (6). Moreover, consensus recommendations such as those made by the US Preventive Services Task Force suggest that screening only occur in settings where evidence-based counselling such as CBT is readily available (7). In order to increase access to treatment, screening efforts have been undertaken by public health units province-wide in Ontario. This has occurred despite the widespread availability of evidence-based psychotherapies.
A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each of 5 settings (Simcoe County, Kitchener-Waterloo Region, Halton Region, Prince Edward County, Elgin County), and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.
If this intervention is eventually proven effective, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced. Providing women with PPD with CBT skills at this crucial stage in life also has the capacity to prevent future depressive relapse with significant benefits for patients, families, employers, and the healthcare system.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8S 4L8
- McMaster University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- infant <12 months
- 18 years or older
- EPDS score >10
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1-Day CBT Workshop - Immediate
Women assigned to the immediate workshop group will participate in the first of two workshops (9 weeks apart).
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The intervention is a 1-day Cognitive Behavioural Therapy based workshop.
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Experimental: 1-Day CBT Workshop - Waitlist
Women assigned to the waitlist will participate in the second of two workshops (12 weeks apart).
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The intervention is a 1-day Cognitive Behavioural Therapy based workshop.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: 3 months
|
EPDS is the 10-item gold standard measure of PPD.
A score >10 is consistent with PPD and changes in scores >4 are accepted as being indicative of clinically significant change
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3 months
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Beck Depression Inventory-II
Time Frame: 3 months
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The Beck Depression Inventory is a 21-item scale that assesses the emotional and cognitive symptoms of depression as the EPDS does, but additionally captures the somatic symptoms of depression.
Higher scores on the BDI-II indicate more sever depression.
The minimum score is 0 and maximum score is 63.
Items are summed to generate a total score.
0-13 = minimal depression; 14-19 = mild depression; 20-28 = moderate depression; 29-63 = severe depression.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 3 months
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The GAD-7 is a 7-item self-report scale that taps generalized anxiety disorder, the most common comorbidity of PPD.
The minimum score is 0 and the maximum score is 21.
Items are summed to generate a total score.
Scores of 5-9 indicate mild anxiety, 10-14 indicate moderate anxiety and 15 or greater indicate severe anxiety.
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3 months
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Postpartum Bonding Questionnaire
Time Frame: 3 months
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Postpartum Bonding Questionnaire is a 25-item maternal report scale that is designed to detect disorders of the mother-infant relationship.
Scores range on each question from 0 (Always) to 5 (Never) and are summed to generate subscale scores.
The subscales include: impaired bonding, rejection and pathological anger, infant focused anxiety and incipient abuse.
Higher scores indicate problems with bonding.
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3 months
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Client Satisfaction Questionnaire
Time Frame: Immediately after workshop
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The Client Satisfaction Questionnaire (CSQ-8) is an 8-item patient reported scale that is designed to measure client satisfaction with services.
The Maximum score is 32 and the minimum score is 4. Higher scores indicate greater satisfaction.
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Immediately after workshop
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Healthcare Utilization
Time Frame: 3 months
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As depression is associated with increased rates of healthcare use, mothers will answer the Health Care Utilization questions of the Canadian Community Health Survey at all time points.
Mothers will also answer the General Help-Seeking Questionnaire and the Mental Help Seeking Intention Scale at all time points, in order to measure the likelihood that they will seek help from healthcare professionals.
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3 months
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Infant Behaviour Questionnaire-Revised (Very short form)
Time Frame: 3 months
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To assess infant temperament if infants.
The measure takes a mean value of the questions to which a response was provided.
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3 months
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Strengths and Difficulties Questionnaire
Time Frame: 3 months
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To assess temperament of 2-4 year olds.
Each response has values of 0, 1 and 2. These are summed to generate a total score for each subscale: Emotional Problems Scale, Conduct Problems Scale, Hyperactivity Scale, Peer Problems Scale, Prosocial Scale.
The minimum score for each scale is 0 and the maximum is 10.
Higher scores indicate greater difficulties.
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3 months
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Early Childhood Behaviour Questionnaire (very short form)
Time Frame: 3 months
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To assess temperament of children 18-36 months.
The subscales include negative affect, surgency and effortful control.
The measure takes a mean value of the questions to which a response was provided.
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3 months
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EQ-5D
Time Frame: 3 months
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The EQ-5D, a measure of health-related quality of life will also be completed by mothers.
Health status is measured on five dimensions on three-point scales.
The associated tariffs for Canada are then applied to calculate quality-adjusted life-years (QALYs).
The instrument also includes a visual analogue scale, allowing individuals to rate their current health status on a scale from 0 (worst) to 100 (best).
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3 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1Day-CBT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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