Postpartum Depression Clinical Trial
— OPTIMUMOfficial title:
Out-patient Group Therapy Using Interpersonal Psychotherapy for Mums With Postpartum Depression: the OPTIMUM Study: a Randomized Controlled Trial
NCT number | NCT04580901 |
Other study ID # | 10612 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 21, 2020 |
Est. completion date | March 2023 |
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.
Status | Recruiting |
Enrollment | 126 |
Est. completion date | March 2023 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster Univeristy | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Hamilton Academic Health Sciences Organization |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | To be measured immediately after 12 weeks of group IPT | |
Primary | 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). | To be measured immediately after 12 weeks of group IPT | |
Secondary | 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). | Immediately after 12 weeks of group IPT | |
Secondary | 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). | Immediately after 12 weeks of group IPT | |
Secondary | 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). | Immediately after 12 weeks of group IPT | |
Secondary | 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). | Immediately after 12 weeks of group IPT | |
Secondary | 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). | Immediately after 12 weeks of group IPT | |
Secondary | 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). | Immediately after 12 weeks of group IPT |
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