Clinical trial NCT04580901: IPT-G for Mums With Postpartum Depression
Official title: Out-patient Group Therapy Using Interpersonal Psychotherapy for Mums With Postpartum Depression: the OPTIMUM Study: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Keywords: postpartum
perinatal
depression
depressive disorder
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Academic Health Sciences Organization
First posted: 2020-10-09
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Depressive symptoms on Edinburgh Postpartum Depression scale
timeFrame: To be measured immediately after 12 weeks of group IPT
measure: Depressive symptoms on Patient Health Questionnaire-9 (PHQ-9)
timeFrame: To be measured immediately after 12 weeks of group IPT
Secondary outcomes:
measure: Anxiety
timeFrame: Immediately after 12 weeks of group IPT
measure: Acceptability
timeFrame: Immediately after 12 weeks of group IPT
measure: Social Support
timeFrame: Immediately after 12 weeks of group IPT
measure: Functioning
timeFrame: Immediately after 12 weeks of group IPT
measure: Anxiety
timeFrame: Immediately after 12 weeks of group IPT
measure: Postpartum bonding
timeFrame: Immediately after 12 weeks of group IPT
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Univeristy
state: Ontario
Study officials:
affiliation: McMaster University
name: Vivian Polak, HBA BMSc MD
role: PRINCIPAL_INVESTIGATOR
References: