Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2014

Interventions

  • Behavioral: Group Interpersonal Psychotherapy (IPT-G)
  • Behavioral: Coping with Depression (CWD)

Arms, Groups and Cohorts

  • Experimental: Group Interpersonal Psychotherapy (IPT-G)
    • Participants in the IPT-G condition will receive 12 group therapy sessions over 2 weeks as well as 2 individual (pre-group and 1-month booster sessions). In addition, 3 of the 12 group sessions will invite women to include their partners or other support people to bolster the woman’s social support system and to reduce conflicts over how to react to the loss. This study adapted IPT for treatment of depression after perinatal loss.
  • Active Comparator: Coping with Depression (CWD)
    • The Coping with Depression (CWD) course is a highly structured, manualized psycho-educational group treatment for MDD. The course content is cognitive-behavioral in nature and is designed to train skills that can be used in the alleviation of depression. The skill modules focus on relaxation, cognitive skills, and behavioral activation. CWD will consist of an individual pre-group interview, 12 group therapy sessions over 12 weeks and a 1-month individual booster session to provide an identical treatment dose as the experimental condition.

Clinical Trial Outcome Measures

Primary Measures

  • Treatment Acceptability
    • Time Frame: Post Treatment (12 Weeks)
    • Treatment acceptability measured by the End of Treatment Questionnaire and the client satisfaction questionnaire.
  • Reduced time to remission from major depressive disorder (exploratory in this underpowered feasibility/acceptability study)
    • Time Frame: Survival analysis
    • We will calculate the effect size and confidence intervals for time to remission from depressive episode. Remission will be defined as number of weeks until Hamilton Rating Scale for Depression score of 7 or less. Recovery from major depression is an exploratory aim; it will be defined as 8+ consecutive weeks on the Longitudinal Interval Follow-up Evaluation PSR scores of 1 or 2. Exploratory tests for differences between conditions will use Cox regression, with initial HRSD scores as a covariate.
  • Reduction in depressive symptoms (exploratory in this underpowered feasibility/acceptability study)
    • Time Frame: Slopes over time
    • We will calculate the effect sizes and confidence intervals for reduction in depressive symptoms using HRSD and BDI-II scores. Exploratory tests for differences between conditions will use HLM with baseline scores as covariates.

Secondary Measures

  • Perceived Social Support
    • Time Frame: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
    • We will calculate effect sizes and confidence intervals for improvement in social support and social functioning using the Multidimensional Scale of Perceived Social Support and the Social Adjustment Scale. Exploratory tests for differences between conditions will use HLM with baseline scores as covariates.
  • Couple Distress
    • Time Frame: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
    • Social adjustment as measured by the Dyadic Adjustment Scale (DAS). We will calculate effect sizes and confidence intervals for reduction in couple distress using the DAS. Exploratory tests for differences between conditions will use HLM with baseline DAS scores as a covariate.
  • Grief
    • Time Frame: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
    • Grief as measured by the Perinatal Bereavement Grief Scale and the Inventory of Complicated Grief. We will calculate effect sizes and confidence intervals for reduction in grief using the PBGS and ICG. Exploratory tests for differences between conditions will use HLM with baseline scores as covariates. Although not the primary focus of this study, we will also calculate the NNT for prevention of complicated grief diagnosis.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Brown University
  • Collaborator
    • National Institute of Mental Health (NIMH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Jennifer Johnson, Associate Professor (Research) – Brown University
  • Overall Official(s)
    • Jennifer E. Johnson, Ph.D., Principal Investigator, Brown University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.