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

NCT01867749 | Completed DMC

• 1 other identifier: 5R34MH086682-03
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (3)

• Treatment Acceptability

  Treatment acceptability measured by the End of Treatment Questionnaire and the client satisfaction questionnaire.

  Post Treatment (12 Weeks)

• Reduced time to remission from major depressive disorder (exploratory in this underpowered feasibility/acceptability study)

  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.

  Survival analysis

• Reduction in depressive symptoms (exploratory in this underpowered feasibility/acceptability study)

  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.

  Slopes over time

Secondary Outcomes (3)

• Perceived Social Support

  Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months

• Couple Distress

  Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months

• Grief

  Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months

Study Arms (2)

Group Interpersonal Psychotherapy (IPT-G)

EXPERIMENTAL

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)

Coping with Depression (CWD)

ACTIVE COMPARATOR

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)

Interventions

Group Interpersonal Psychotherapy (IPT-G) BEHAVIORAL

Also known as: IPT-G

Group Interpersonal Psychotherapy (IPT-G)

Coping with Depression (CWD) BEHAVIORAL

Also known as: CWD

Coping with Depression (CWD)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brown University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02096, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Abortion, Spontaneous; Stillbirth; Perinatal Death

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennifer E. Johnson, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 4, 2013
• Study Start: June 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

US (1)