NCT04580901

Brief Summary

Postpartum depression is a very common and costly illness with numerous, long-term deleterious effects for women, their offspring and families; yet most women are not treated. Group IPT delivered virtually offers women a 1st-line, low-cost intervention that overcomes existing treatment barriers. To test its acceptability and effectiveness, a RCT will be conducted to compare virtually delivered group IPT immediately to usual care in women in Ontario Canada who have postpartum depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 21, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

September 25, 2020

Last Update Submit

November 4, 2024

Conditions

Postpartum Depression

Keywords

postpartumperinataldepressiondepressive disorder

Outcome Measures

Primary Outcomes (2)

  • Depressive symptoms on Edinburgh Postpartum Depression scale

    Pre-treatment to post-treatment comparison of depressive symptoms measured via EPDS. Scale is measured from 1 (no depressive symptoms) to 4 (worst depressive symptoms) with 0 being the lowest score (best outcome) and 30 being the highest score (worst outcome).

    To be measured immediately after 12 weeks of group IPT

  • Depressive symptoms on Patient Health Questionnaire-9 (PHQ-9)

    Pre-treatment to post-treatment comparison of depressive symptoms measured via PHQ-9. Scale is measured from 0 (no depressive symptoms) to 3 (worst depressive symptoms) with 0 being the lowest score (best outcome) and 27 being the highest score (worst outcome).

    To be measured immediately after 12 weeks of group IPT

Secondary Outcomes (6)

  • Anxiety

    Immediately after 12 weeks of group IPT

  • Acceptability

    Immediately after 12 weeks of group IPT

  • Social Support

    Immediately after 12 weeks of group IPT

  • Functioning

    Immediately after 12 weeks of group IPT

  • Anxiety

    Immediately after 12 weeks of group IPT

  • +1 more secondary outcomes

Study Arms (2)

Group interpersonal psychotherapy

EXPERIMENTAL

Group IPT consists of 12 weeks of virtually delivered therapy by two co-therapists via Zoom to a group of 6-8 women. The 12 weeks consist of 15 sessions over 12 weeks of group IPT taking place virtually via Zoom (2 sessions per week for the first 4 weeks (acute phase) then once a week for 6 weeks, then a two-week space before the last session).

Behavioral: Group Interpersonal Psychotherapy

Usual care

NO INTERVENTION

Usual care refers to any care that the women wish to access, and there are no limits on the women in either group. It may include, but is not limited to, the family physician, obstetrician, and/or midwife, participation in regional standard perinatal depression programming, private therapy, online therapies, medication, etc.

Interventions

Group Interpersonal PsychotherapyBEHAVIORAL

Group IPT consists of 12 weeks of virtually delivered therapy by two co-therapists via Zoom to a group of 6-8 women. The 12 weeks consist of 15 sessions over 12 weeks of group IPT taking place virtually via Zoom (2 sessions per week for the first 4 weeks (acute phase) then once a week for 6 weeks, then a two-week space before the last session).

Also known as: Group IPT
Group interpersonal psychotherapy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years or older
  • postpartum with baby under 1 year
  • score greater than or equal to 10 on the Edinburgh Postnatal Depression Scale (EPDS)

You may not qualify if:

  • active alcohol or substance use disorder
  • bipolar disorder
  • borderline personality
  • antisocial personality
  • PTSD
  • psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster Univeristy

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

Depression, PostpartumDepressionDepressive Disorder

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Vivian Polak, HBA BMSc MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 9, 2020

Study Start

December 21, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

November 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)