IPT-G for Mums With Postpartum Depression

NCT ID: NCT04580901

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-21
• Study Completion Date: 2022-03-01

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.

Detailed Description

Depression during pregnancy and in the first year following delivery affects 15-20% of women. Left untreated, these disorders increase the risk of future depressive episodes, postpartum depression in their partners, as well as emotional, behavioural, and cognitive problems in offspring. Unfortunately, up to 85% of these women will not receive treatment, which is estimated to cost the province of Ontario upwards of $6 billion annually. There is significant stigma surrounding perinatal depression which can result in less help-seeking by women, as well as a lack of awareness about available non-medication treatment options among both physicians and patients, even though most women prefer psychotherapy over medication.

Despite the very strong evidence base for IPT, relatively few clinicians are trained to deliver IPT. Rather than travelling to tertiary care centres, the delivery of group psychotherapy virtually via telemedicine or Zoom allows women anywhere in the province to access this highly effective first-line treatment, thereby increasing access for women with perinatal depression and improving outcomes for mothers, babies, and families in Ontario.

Study Objective: To compare the effectiveness of virtual group IPT to usual care in women with postpartum depression symptoms for reducing depression symptoms and anxiety, improving mother-infant attachment, and increasing social support, functioning, and quality of life.

Study Design: RCT Population: postpartum women, aged 18 or older, with a baby under a year old Intervention: 12 weeks (15 sessions - 12 acute, 3 maintenance sessions) of group IPT delivered virtually via Zoom Comparison: 12 weeks of usual care followed by group IPT Outcomes: Pre-treatment versus post-treatment change in depression symptoms, anxiety, acceptability, mother-infant bonding, social support & functioning, and quality of life.

All women in the study will be able to access care as usual from their physicians and other therapists throughout the study.

Conditions

Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group interpersonal psychotherapy

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).

Group Type: EXPERIMENTAL

Group Interpersonal Psychotherapy

Intervention Type: BEHAVIORAL

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).

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group Interpersonal Psychotherapy

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Group IPT

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Academic Health Sciences Organization

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vivian Polak, HBA BMSc MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster Univeristy

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

10612

Identifier Type: -

Identifier Source: org_study_id