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Completed

NCT Number: NCT01867749

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

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.

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Key information

Conditions

Major Depressive Disorder Abortion, Spontaneous Death Depressive Disorder Depressive Disorder, Major Female Urogenital Diseases and Pregnancy Complications Fetal Death Mental Disorders Miscarriage Mood Disorders Neonatal Death Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Stillbirth Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02096, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group interpersonal psychotherapy (IPT-G)

Behavioral

Other names: IPT-G

Coping with Depression (CWD)

Behavioral

Other names: CWD

Primary outcomes

  1. Treatment Acceptability

    Time frame: Post Treatment (12 Weeks)

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

  2. 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.

  3. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2013
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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