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

Primary Purpose

Major Depressive Disorder, Miscarriage, Stillbirth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Interpersonal Psychotherapy (IPT-G)
Coping with Depression (CWD)
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder (MDD), Miscarriage, Stillbirth, Neonatal death, Interpersonal psychotherapy, Group Therapy, Coping with Depression (CWD)

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group Interpersonal Psychotherapy (IPT-G)

Coping with Depression (CWD)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Treatment Acceptability
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)
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)
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
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
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
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.

Full Information

First Posted
May 28, 2013
Last Updated
January 12, 2016
Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01867749
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Miscarriage, Stillbirth, Neonatal Death
Keywords
Major Depressive Disorder (MDD), Miscarriage, Stillbirth, Neonatal death, Interpersonal psychotherapy, Group Therapy, Coping with Depression (CWD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Interpersonal Psychotherapy (IPT-G)
Arm Type
Experimental
Arm Description
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.
Arm Title
Coping with Depression (CWD)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Interpersonal Psychotherapy (IPT-G)
Other Intervention Name(s)
IPT-G
Intervention Type
Behavioral
Intervention Name(s)
Coping with Depression (CWD)
Other Intervention Name(s)
CWD
Primary Outcome Measure Information:
Title
Treatment Acceptability
Description
Treatment acceptability measured by the End of Treatment Questionnaire and the client satisfaction questionnaire.
Time Frame
Post Treatment (12 Weeks)
Title
Reduced time to remission from major depressive disorder (exploratory in this underpowered feasibility/acceptability study)
Description
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.
Time Frame
Survival analysis
Title
Reduction in depressive symptoms (exploratory in this underpowered feasibility/acceptability study)
Description
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.
Time Frame
Slopes over time
Secondary Outcome Measure Information:
Title
Perceived Social Support
Description
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.
Time Frame
Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
Title
Couple Distress
Description
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.
Time Frame
Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
Title
Grief
Description
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.
Time Frame
Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer E. Johnson, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02096
Country
United States

12. IPD Sharing Statement

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

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