1 Day Workshops for Preventing PPD: A Pilot Study

NCT05040581 | Completed

• 1 other identifier: 1DayPrev
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (6)

• Acceptability of developed treatment manual

  this outcome will be assessed using open-ended questions in an electronic survey to elicit participant feedback

  6 months

• Feasibility of recruiting 15 mothers into a pilot workshop

  counts will be used to determine the number of participants recruited into the pilot workshop

  6 months

• 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

  6 months

• Proportion of eligible participants who enroll in study

  counts will be used to determine the proportion of eligible participants who enroll in the study

  6 months

• Proportion of participants in experimental arm who complete intervention

  counts will be used to determine the proportion of participants who complete the intervention

  6 months

• Proportion of participants who complete all outcome measures

  Counts will be used to determine the number of participants who complete the outcome measures

  6 months

Secondary Outcomes (2)

• Estimate of treatment effect and variance of primary outcome for later RCT - Major Depressive Disorder

  measured at 1, 2, and 3 months postpartum

• Estimate of treatment effect and variance of primary outcome for later RCT - Depressive Symptoms

  measured at 1, 2, and 3 months postpartum

Study Arms (1)

Experimental Group - 1 Day CBT

EXPERIMENTAL

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.

Behavioral: 1-Day CBT-Based Workshop for Preventing PPD

Interventions

1-Day CBT-Based Workshop for Preventing PPD BEHAVIORAL

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.

Experimental Group - 1 Day CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ryan Van Lieshout, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Objective 2 will be addressed using a single-group pre-post design (n=15).

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: September 10, 2021
• Study Start: June 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)