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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Jennifer Johnson, Brown University
ClinicalTrials.gov Identifier:
NCT01867749
First received: May 28, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.

Condition Intervention
Major Depressive Disorder
Miscarriage
Stillbirth
Neonatal Death
Behavioral: Group Interpersonal Psychotherapy (IPT-G)
Behavioral: Coping with Depression (CWD)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Treatment Acceptability [ Time Frame: Post Treatment (12 Weeks) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Perceived Social Support [ Time Frame: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Group Interpersonal Psychotherapy (IPT-G)
Other Name: IPT-G
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.
Behavioral: Coping with Depression (CWD)
Other Name: CWD

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01867749

Locations
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02096
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Jennifer E. Johnson, Ph.D. Brown University
  More Information

No publications provided

Responsible Party: Dr. Jennifer Johnson, Associate Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT01867749     History of Changes
Other Study ID Numbers: 5R34MH086682-03, 5R34MH086682-03
Study First Received: May 28, 2013
Last Updated: June 3, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Brown University:
Major Depressive Disorder (MDD)
Miscarriage
Stillbirth
Neonatal death
Interpersonal psychotherapy
Group Therapy
Coping with Depression (CWD)

Additional relevant MeSH terms:
Abortion, Spontaneous
Death
Depressive Disorder
Depression
Depressive Disorder, Major
Pregnancy Complications
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 28, 2014