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Completed

NCT Number: NCT04580901

IPT-G for Mums With Postpartum Depression

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.

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Key information

Conditions

Postpartum Depression Behavior Behavioral Symptoms Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Univeristy

Hamilton, Ontario, L8S 4L8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Interpersonal Psychotherapy

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).

Other names: Group IPT

Primary outcomes

  1. Depressive symptoms on Edinburgh Postpartum Depression scale

    Time frame: To be measured immediately after 12 weeks of group IPT

    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).

  2. Depressive symptoms on Patient Health Questionnaire-9 (PHQ-9)

    Time frame: To be measured immediately after 12 weeks of group IPT

    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).

Secondary outcomes

  1. Anxiety

    Time frame: Immediately after 12 weeks of group IPT

    Pre-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).

  2. Acceptability

    Time frame: Immediately after 12 weeks of group IPT

    Acceptability 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).

  3. Social Support

    Time frame: Immediately after 12 weeks of group IPT

    Pre-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).

  4. Functioning

    Time frame: Immediately after 12 weeks of group IPT

    Pre-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).

  5. Anxiety

    Time frame: Immediately after 12 weeks of group IPT

    Pre-treatment to post-treatment comparison of anxiety symptoms measured via Zung Self-Rating Anxiety scale. Scale is measured from 1 (least anxiety) to 4 (most anxiety) with 20 being the lowest score (best outcome) and 80 being the highest score (worst outcome).

  6. Postpartum bonding

    Time frame: Immediately after 12 weeks of group IPT

    Postpartum 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).

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Academic Health Sciences Organization

Registry information

Official study title

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

Acronym: OPTIMUM

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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