Clinical trial NCT01867749: Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss
Official title: Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Miscarriage
Stillbirth
Neonatal Death
Keywords: Major Depressive Disorder (MDD)
Miscarriage
Stillbirth
Neonatal death
Interpersonal psychotherapy
Group Therapy
Coping with Depression (CWD)
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-06-04
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to demonstrate the feasibility of the proposed recruitment methods and research design, of the therapist training methods, and of delivering the adapted Interpersonal Psychotherapy group treatment.

The investigators would like to examine preliminary evidence for the following hypotheses:

* Perinatal-loss specific IPT-G will be more acceptable to women who experience MDD following perinatal loss than will Coping with Depression (CWD).
* Perinatal-loss specific IPT-G will result in reduced time to remission from MDD and reduced depressive symptoms relative to CWD.
* Perinatal-loss specific IPT-G will result in increased social support and social functioning, reduced couple distress, and reduced grief relative to CWD.


Eligibility criteria: Inclusion Criteria:

* Current Major Depressive episode.
* Experience perinatal loss 1-18 months prior to intake (including early and late fetal death and the death of a live born neonate within the first 28 days).

Exclusion Criteria:

* Untreated thyroid difficulties (TSH levels out of the normal range).
* Anemia (hemoglobin or hematocrit out of the normal range).
* Onset of current major depressive episode prior to news of difficulties with the pregnancy or health risk to the infant (women with prior episodes will be included).
* Current or past diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder.
* Primary diagnosis of substance dependence or eating disorder.
* Acute suicidal or homicidal risk.
* Non-stable course of antidepressant medication or psychotherapy (i.e., beginning or changing dose of either within the previous 8 weeks).
* Any IPT or cognitive-behavioral treatment in the previous 8 weeks.

Primary outcomes:
measure: Treatment Acceptability
timeFrame: Post Treatment (12 Weeks)
measure: Reduced time to remission from major depressive disorder (exploratory in this underpowered feasibility/acceptability study)
timeFrame: Survival analysis
measure: Reduction in depressive symptoms (exploratory in this underpowered feasibility/acceptability study)
timeFrame: Slopes over time
Secondary outcomes:
measure: Perceived Social Support
timeFrame: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
measure: Couple Distress
timeFrame: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
measure: Grief
timeFrame: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jennifer E. Johnson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: