search
Back to results

1 Day Workshops for Preventing PPD: A Pilot Study

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
1-Day CBT-Based Workshop for Preventing PPD
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years of age or older
  • >28 weeks pregnant
  • do not meet diagnostic criteria for a current major depressive episode (determined using the Mini International Neuropsychiatric Interview (MINI))
  • Presence of one or more of the following risk factors for PPD:
  • Past history of major depressive disorder or generalized anxiety disorder (Mini International Neuropsychiatric Interview (MINI))
  • Low SES (Canadian Household Low Income Cut-Off (LICOs) Before Tax)
  • Single marital status (Antenatal (Psychosocial) Risk Questionnaire (ANRQ))
  • Major life stress in past 12 months (Antenatal (Psychosocial) Risk Questionnaire (ANRQ))
  • Major life stress in past 12 months (Antenatal (Psychosocial) Risk Questionnaire (ANRQ))
  • History of physical and/or sexual abuse (Antenatal (Psychosocial) Risk Questionnaire (ANRQ))
  • Perceived low social support (Antenatal (Psychosocial) Risk Questionnaire (ANRQ))

Exclusion Criteria:

  • Bipolar, psychotic and/or current substance use disorders (determined using the Mini International Neuropsychiatric Interview (MINI))

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group - 1 Day CBT

Arm Description

The intervention is a 6-hour long CBT-based workshop. Cognitive behavioural therapy is a structured psychotherapy based on the cognitive theory of depression that posits that negative thoughts about the self, others and the future can lead to and perpetuate depressed mood states. CBT equips participants with skills that enable them to identify and modify distortions in their thinking that lead to depressed mood and maladaptive behavioural responses. The intervention will be delivered in in modules and contain content on PPD etiology (with a focus on modifiable risk factors), the development of cognitive skills including cognitive restructuring, behavioural skills such as problem solving, sleep strategies, behavioural activation, assertiveness, and self-care, and the final module will involve goal setting and action planning.

Outcomes

Primary Outcome Measures

Acceptability of developed treatment manual
this outcome will be assessed using open-ended questions in an electronic survey to elicit participant feedback
Feasibility of recruiting 15 mothers into a pilot workshop
counts will be used to determine the number of participants recruited into the pilot workshop
Feasibility of recruiting 60 participants into pilot RCT in 6 months
counts will be used to determine the number of participants recruited into the pilot RCT
Proportion of eligible participants who enroll in study
counts will be used to determine the proportion of eligible participants who enroll in the study
Proportion of participants in experimental arm who complete intervention
counts will be used to determine the proportion of participants who complete the intervention
Proportion of participants who complete all outcome measures
Counts will be used to determine the number of participants who complete the outcome measures

Secondary Outcome Measures

Estimate of treatment effect and variance of primary outcome for later RCT - Major Depressive Disorder
Measured using Mini International Neuropsychiatric Interview Major Depressive Disorder Module to determine if participants meet diagnostic criteria for PPD
Estimate of treatment effect and variance of primary outcome for later RCT - Depressive Symptoms
Measured using the Edinburgh Postnatal Depression Scale (EPDS) to assess level of depressive symptoms. The EPDS is a self-report measure that produces scores ranging from 0-30, with higher scores indicating higher levels of depressive symptoms. Scores of 13 or more suggest probable PPD.

Full Information

First Posted
June 9, 2021
Last Updated
February 28, 2023
Sponsor
McMaster University
search

1. Study Identification

Unique Protocol Identification Number
NCT05040581
Brief Title
1 Day Workshops for Preventing PPD: A Pilot Study
Official Title
Online 1-Day Cognitive Behavioural Therapy-Based Workshops for Preventing Postpartum Depression: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (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
The aim of this pilot study is to (1) develop a treatment manual for a 1-Day CBT-Based Workshop for preventing postpartum depression that is acceptable to women; (2) recruit 15 women into a pilot workshop and seek their feedback on content, delivery and assessment procedures; and (3) conduct a small pilot randomized controlled trial (n=60) examining the impact of these workshops on rates of PPD when added to care as usual (CAU) more than CAU alone in addition to a 90-minute information session on PPD.
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 will develop the content for our prevention workshop as well as an accompanying script and intervention manual for participants (Objective 1). They will then advertise and assess the feasibility of recruiting 15 women into a pilot workshop and seek their feedback on its content, delivery and assessment procedures (Objective 2). Using these data, the workshop will be revised, and the investigators will conduct a small pilot randomized controlled trial (n=60) examining the impact of these workshops on rates of PPD when added to care as usual (CAU) more than CAU alone in addition to a 90-minute information session on PPD (Objective 3). These objectives will enable us to develop and deliver this intervention, assess the feasibility of our recruitment strategy, determine recruitment and retention rates, assess study personnel needs, refine the study protocol and estimate effect sizes for group differences in support of a larger, full-scale trial aimed as assessing the effectiveness of these workshops at reducing the likelihood of developing PPD in women at risk. The pilot study will be considered successful and proceed to a larger trial in the future if: The treatment manual for the workshop is acceptable to women 15 women are recruited into a pilot workshop within three months and have 70% complete their follow-up measures Recruit and randomize 60 women over six months into two separate workshop/info sessions (each consisting of 15 in the workshop and 15 into the control information session) and: 70% of eligible sign-ups enroll in the study 75% of participants assigned to experimental group complete intervention 70% of participants complete all follow-up measures Estimate a treatment effect and variance (measured using Mini International Neuropsychiatric Interview Major Depressive Disorder Module and the Edinburgh Postnatal Depression Scale)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Objective 2 will be addressed using a single-group pre-post design (n=15).
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group - 1 Day CBT
Arm Type
Experimental
Arm Description
The intervention is a 6-hour long CBT-based workshop. Cognitive behavioural therapy is a structured psychotherapy based on the cognitive theory of depression that posits that negative thoughts about the self, others and the future can lead to and perpetuate depressed mood states. CBT equips participants with skills that enable them to identify and modify distortions in their thinking that lead to depressed mood and maladaptive behavioural responses. The intervention will be delivered in in modules and contain content on PPD etiology (with a focus on modifiable risk factors), the development of cognitive skills including cognitive restructuring, behavioural skills such as problem solving, sleep strategies, behavioural activation, assertiveness, and self-care, and the final module will involve goal setting and action planning.
Intervention Type
Behavioral
Intervention Name(s)
1-Day CBT-Based Workshop for Preventing PPD
Intervention Description
The intervention is a 6-hour long CBT-based workshop. The intervention will be delivered in in modules and contain content on PPD etiology (with a focus on modifiable risk factors), the development of cognitive skills including cognitive restructuring, behavioural skills such as problem solving, sleep strategies, behavioural activation, assertiveness, and self-care, and the final module will involve goal setting and action planning.
Primary Outcome Measure Information:
Title
Acceptability of developed treatment manual
Description
this outcome will be assessed using open-ended questions in an electronic survey to elicit participant feedback
Time Frame
6 months
Title
Feasibility of recruiting 15 mothers into a pilot workshop
Description
counts will be used to determine the number of participants recruited into the pilot workshop
Time Frame
6 months
Title
Feasibility of recruiting 60 participants into pilot RCT in 6 months
Description
counts will be used to determine the number of participants recruited into the pilot RCT
Time Frame
6 months
Title
Proportion of eligible participants who enroll in study
Description
counts will be used to determine the proportion of eligible participants who enroll in the study
Time Frame
6 months
Title
Proportion of participants in experimental arm who complete intervention
Description
counts will be used to determine the proportion of participants who complete the intervention
Time Frame
6 months
Title
Proportion of participants who complete all outcome measures
Description
Counts will be used to determine the number of participants who complete the outcome measures
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Estimate of treatment effect and variance of primary outcome for later RCT - Major Depressive Disorder
Description
Measured using Mini International Neuropsychiatric Interview Major Depressive Disorder Module to determine if participants meet diagnostic criteria for PPD
Time Frame
measured at 1, 2, and 3 months postpartum
Title
Estimate of treatment effect and variance of primary outcome for later RCT - Depressive Symptoms
Description
Measured using the Edinburgh Postnatal Depression Scale (EPDS) to assess level of depressive symptoms. The EPDS is a self-report measure that produces scores ranging from 0-30, with higher scores indicating higher levels of depressive symptoms. Scores of 13 or more suggest probable PPD.
Time Frame
measured at 1, 2, and 3 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years of age or older >28 weeks pregnant do not meet diagnostic criteria for a current major depressive episode (determined using the Mini International Neuropsychiatric Interview (MINI)) Presence of one or more of the following risk factors for PPD: Past history of major depressive disorder or generalized anxiety disorder (Mini International Neuropsychiatric Interview (MINI)) Low SES (Canadian Household Low Income Cut-Off (LICOs) Before Tax) Single marital status (Antenatal (Psychosocial) Risk Questionnaire (ANRQ)) Major life stress in past 12 months (Antenatal (Psychosocial) Risk Questionnaire (ANRQ)) Major life stress in past 12 months (Antenatal (Psychosocial) Risk Questionnaire (ANRQ)) History of physical and/or sexual abuse (Antenatal (Psychosocial) Risk Questionnaire (ANRQ)) Perceived low social support (Antenatal (Psychosocial) Risk Questionnaire (ANRQ)) Exclusion Criteria: Bipolar, psychotic and/or current substance use disorders (determined using the Mini International Neuropsychiatric Interview (MINI))
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

Learn more about this trial

1 Day Workshops for Preventing PPD: A Pilot Study

We'll reach out to this number within 24 hrs