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IPT-G for Mums With Postpartum Depression (OPTIMUM)

Primary Purpose

Postpartum Depression

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group Interpersonal Psychotherapy
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring postpartum, perinatal, depression, depressive disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster UniveristyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group interpersonal psychotherapy

Usual care

Arm Description

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, with the first 12 sessions taking place twice weekly (acute phase) for 6 weeks and the last 3 sessions occurring every other week (maintenance phase) for 6 weeks.

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Anxiety
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).
Anxiety
Pre-treatment to post-treatment comparison of anxiety symptoms measured via Zung 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).
Acceptability
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).
Postpartum bonding
Postpartum Bonding Scale 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).
Social Support
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).
Functioning
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).

Full Information

First Posted
September 25, 2020
Last Updated
March 4, 2021
Sponsor
McMaster University
Collaborators
Hamilton Academic Health Sciences Organization
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1. Study Identification

Unique Protocol Identification Number
NCT04580901
Brief Title
IPT-G for Mums With Postpartum Depression
Acronym
OPTIMUM
Official Title
Out-patient Group Therapy Using Interpersonal Psychotherapy for Mums With Postpartum Depression: the OPTIMUM Study: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Hamilton Academic Health Sciences Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
postpartum, perinatal, depression, depressive disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group interpersonal psychotherapy
Arm Type
Experimental
Arm Description
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, with the first 12 sessions taking place twice weekly (acute phase) for 6 weeks and the last 3 sessions occurring every other week (maintenance phase) for 6 weeks.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Interpersonal Psychotherapy
Other Intervention Name(s)
Group IPT
Intervention Description
15 sessions over 12 weeks of group IPT taking place virtually via Zoom (2 sessions per week for the first 6 weeks (acute phase) then every other week for 6 weeks (maintenance phase)
Primary Outcome Measure Information:
Title
Depressive symptoms on Edinburgh Postpartum Depression scale
Description
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).
Time Frame
To be measured immediately after 12 weeks of group IPT
Title
Depressive symptoms on Patient Health Questionnaire-9 (PHQ-9)
Description
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).
Time Frame
To be measured immediately after 12 weeks of group IPT
Secondary Outcome Measure Information:
Title
Anxiety
Description
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).
Time Frame
Immediately after 12 weeks of group IPT
Title
Anxiety
Description
Pre-treatment to post-treatment comparison of anxiety symptoms measured via Zung 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).
Time Frame
Immediately after 12 weeks of group IPT
Title
Acceptability
Description
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).
Time Frame
Immediately after 12 weeks of group IPT
Title
Postpartum bonding
Description
Postpartum Bonding Scale 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).
Time Frame
Immediately after 12 weeks of group IPT
Title
Social Support
Description
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).
Time Frame
Immediately after 12 weeks of group IPT
Title
Functioning
Description
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).
Time Frame
Immediately after 12 weeks of group IPT

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vivian Polak, HBA BMSc MD
Phone
519-803-4718
Email
polakv@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Van Lieshout, MD PhD
Phone
905-522-1155
Ext
35123
Email
vanlierj@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian Polak, HBA BMSc MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Univeristy
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian Polak, HBA BMSc MD
Phone
519-803-4718
Email
polakv@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Ryan Van Lieshout, MD PhD
Phone
905-522-1155
Ext
35123
Email
vanlierj@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Lena Verdeli, PhD
First Name & Middle Initial & Last Name & Degree
Mark Ferro, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

IPT-G for Mums With Postpartum Depression

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