search
Back to results

1-Day CBT Workshops for PPD

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring Cognitive Therapy, Workshop, Postpartum Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • infant <12 months
  • 18 years or older
  • EPDS score >10

Exclusion Criteria:

-

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1-Day CBT Workshop - Immediate

1-Day CBT Workshop - Waitlist

Arm Description

Women assigned to the immediate workshop group will participate in the first of two workshops (9 weeks apart).

Women assigned to the waitlist will participate in the second of two workshops (12 weeks apart).

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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).

Full Information

First Posted
August 29, 2018
Last Updated
May 18, 2022
Sponsor
McMaster University
search

1. Study Identification

Unique Protocol Identification Number
NCT03654261
Brief Title
1-Day CBT Workshops for PPD
Official Title
1-Day Cognitive Behavioural Therapy Workshops for Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
August 17, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Cognitive Therapy, Workshop, Postpartum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
461 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1-Day CBT Workshop - Immediate
Arm Type
Experimental
Arm Description
Women assigned to the immediate workshop group will participate in the first of two workshops (9 weeks apart).
Arm Title
1-Day CBT Workshop - Waitlist
Arm Type
Experimental
Arm Description
Women assigned to the waitlist will participate in the second of two workshops (12 weeks apart).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
The intervention is a 1-day Cognitive Behavioural Therapy based workshop.
Primary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
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
Time Frame
3 months
Title
Beck Depression Inventory-II
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
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.
Time Frame
3 months
Title
Postpartum Bonding Questionnaire
Description
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.
Time Frame
3 months
Title
Client Satisfaction Questionnaire
Description
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.
Time Frame
Immediately after workshop
Title
Healthcare Utilization
Description
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.
Time Frame
3 months
Title
Infant Behaviour Questionnaire-Revised (Very short form)
Description
To assess infant temperament if infants. The measure takes a mean value of the questions to which a response was provided.
Time Frame
3 months
Title
Strengths and Difficulties Questionnaire
Description
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.
Time Frame
3 months
Title
Early Childhood Behaviour Questionnaire (very short form)
Description
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.
Time Frame
3 months
Title
EQ-5D
Description
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).
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infant <12 months 18 years or older EPDS score >10 Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Van Lieshout, MD, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34232578
Citation
Layton H, Owais S, Savoy CD, Van Lieshout RJ. Depression, Anxiety, and Mother-Infant Bonding in Women Seeking Treatment for Postpartum Depression Before and During the COVID-19 Pandemic. J Clin Psychiatry. 2021 Jul 6;82(4):21m13874. doi: 10.4088/JCP.21m13874.
Results Reference
derived

Learn more about this trial

1-Day CBT Workshops for PPD

We'll reach out to this number within 24 hrs