1-Day CBT Workshops for PPD

Study Overview
=================
Brief Summary
-----------------
Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families. Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy. 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 setting and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.

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.

Official Title
-----------------
1-Day Cognitive Behavioural Therapy Workshops for Postpartum Depression

Conditions
-----------------
Postpartum Depression

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioural Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infant <12 months 18 years or older EPDS score >10 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1-Day CBT Workshop - Immediate<br>Women assigned to the immediate workshop group will participate in the first of two workshops (9 weeks apart). | Behavioral: Cognitive Behavioural Therapy<br>* The intervention is a 1-day Cognitive Behavioural Therapy based workshop.<br>|
| Experimental: 1-Day CBT Workshop - Waitlist<br>Women assigned to the waitlist will participate in the second of two workshops (12 weeks apart). | Behavioral: Cognitive Behavioural Therapy<br>* The intervention is a 1-day Cognitive Behavioural Therapy based workshop.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Postnatal Depression Scale (EPDS) | 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 | 3 months | 
| Beck Depression Inventory-II | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder-7 (GAD-7) | 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. | 3 months | 
| Postpartum Bonding Questionnaire | 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. | 3 months | 
| Client Satisfaction Questionnaire | 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. | Immediately after workshop | 
| Healthcare Utilization | 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. | 3 months | 
| Infant Behaviour Questionnaire-Revised (Very short form) | To assess infant temperament if infants. The measure takes a mean value of the questions to which a response was provided. | 3 months | 
| Strengths and Difficulties Questionnaire | 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. | 3 months | 
| Early Childhood Behaviour Questionnaire (very short form) | 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. | 3 months | 
| EQ-5D | 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). | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Therapy, Workshop, Postpartum Depression