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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867749
• Other study ID #: 5R34MH086682-03
• Secondary ID: 5R34MH086682-03
• Status: Completed
• Phase: N/A
• First received: May 28, 2013
• Last updated: January 12, 2016
• Start date: June 2010
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Miscarriage
• Neonatal Death
• Stillbirth

Intervention

Behavioral:
• Group Interpersonal Psychotherapy (IPT-G)

• Coping with Depression (CWD)

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Acceptability	Treatment acceptability measured by the End of Treatment Questionnaire and the client satisfaction questionnaire.	Post Treatment (12 Weeks)	No
Primary	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	No
Primary	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	No
Secondary	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.	Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months	No
Secondary	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.	Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months	No
Secondary	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.	Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months	No