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IPT-G for Mums With Postpartum Depression

Out-patient Group Therapy Using Interpersonal Psychotherapy for Mums With Postpartum Depression: the OPTIMUM Study: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04580901
Acronym
OPTIMUM
Enrollment
95
Registered
2020-10-09
Start date
2020-12-21
Completion date
2022-03-01
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Depression

Keywords

postpartum, perinatal, depression, depressive disorder

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.

Interventions

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).

Sponsors

Hamilton Academic Health Sciences Organization
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Depressive symptoms on Edinburgh Postpartum Depression scaleTo be measured immediately after 12 weeks of group IPTPre-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).
Depressive symptoms on Patient Health Questionnaire-9 (PHQ-9)To be measured immediately after 12 weeks of group IPTPre-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).

Secondary

MeasureTime frameDescription
Social SupportImmediately after 12 weeks of group IPTPre-treatment to post-treatment comparison of social supports using the Social Provisions Scale. This 24-item scale is measured from 1 (strongly disagree) to 4 (strongly agree) with 24 being the lowest score (worst outcome) and 96 being the highest score (best outcome).
AnxietyImmediately after 12 weeks of group IPTPre-treatment to post-treatment comparison of anxiety symptoms measured via Generalized Anxiety Disorder-7 scale. Scale is measured from 0 (least anxiety) to 3 (most anxiety) with 0 being the lowest score (best outcome) and 21 being the highest score (worst outcome).
Postpartum bondingImmediately after 12 weeks of group IPTPostpartum Bonding Questionnaire will be used to measure maternal-infant attachment pre- and post-treatment. This 25-item scale is measured from 0 (least bonded) to 5 (most bonded) with 0 being the lowest score (worst outcome) and 125 being the highest score (best outcome).
FunctioningImmediately after 12 weeks of group IPTPre-treatment to post-treatment comparison of functioning using the Sheehan Disability Scale. Scale is measured from 0 (not at all disrupted) to 10 (extremely disrupted) with 0 being the lowest score (best outcome) and 30 being the highest score (worst outcome).
AcceptabilityImmediately after 12 weeks of group IPTAcceptability of the treatment as measured by Client Satisfaction Questionnaire-8. Scale is measured from 1 (least satisfied) to 4 (most satisfied) with 8 being the lowest score (worst outcome) and 32 being the highest score (best outcome).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026