This study tests the efficacy of interpersonal psychotherapy (IPT) for major depression following perinatal loss (early and late fetal death and early neonatal death) in a sample of 274 women in Flint and Detroit, Michigan. The trial will be the first fully powered randomized trial of treatment for any psychiatric disorder following perinatal loss.
The goal of this study is to conduct a fully-powered randomized efficacy study of IPT for MDD following perinatal loss. Our perinatal-loss adapted group IPT will be compared to a standard depression intervention (CWD, also delivered in a group format) in a sample of 274 women experiencing MDD following perinatal loss. The proposed randomized controlled trial (RCT) will test the hypotheses that: (1) IPT for perinatal loss will result in reduced time to recovery from MDD (primary), depressive symptoms, and PTSD symptoms (secondary) relative to CWD; and that among women meeting criteria for PTSD, IPT will result in reduced time to recovery from PTSD; (2) IPT for perinatal loss will result in increased social support, social role functioning (including parental functioning for women with living children), and well-being, and decreased grief and fear of subsequent pregnancies, relative to CWD; and (3) social support and grief will mediate the effects of IPT on time to MDD recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Participants in the IPT condition will receive 12 group sessions and 2 individual (pre-group and 1-month booster) sessions as outlined in the manual The individual sessions prepare patients to use the group effectively, to keep group members focused on their treatment goals, and to maintain treatment gains. 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. These sessions are important because relationship distress is common following perinatal loss. Our IPT intervention allows new women to enter the group every 4 weeks of the 12-week group. Group sessions are semi-structured, and each woman will cover the four group topics three times, approaching each topic from a different stage in the mourning process.
The Coping with Depression (CWD) course is a structured, manualized psycho-educational group treatment for MDD. The CWD course is based on social learning theory which posits that depression is associated with a decrease in pleasant and an increase in unpleasant person-environment interactions. The problems shown by depressed individuals are viewed as behavioral, with cognitive patterns that can be unlearned or relearned. Its effectiveness is comparable to other forms of psychotherapy in depression. 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. As in the pilot trial, CWD will consist of an individual pregroup session, 12 group therapy sessions (allowing new women to enter every 4th session) and a 1-month individual booster session to provide an identical treatment dose as the experimental condition.
Anywhere in the entire state of Michigan (treatment is virtual)
Flint, Michigan, United States
RECRUITINGTime to Major Depressive Disorder recovery
Assessed via the Longitudinal Interview Follow-up Evaluation (LIFE; lower is better)
Time frame: censored at 28 weeks, the proposed study duration
Depressive symptoms
Overall score on the Quick Inventory of Depressive Symptoms (QIDS; lower is better)
Time frame: 8, 16, and 28 weeks after intake
PTSD symptoms
Life Events Checklist and PTSD Checklist for DSM-5 (LEC-PCL; lower is better)
Time frame: 8, 16, and 28 weeks after intake
Time to PTSD recovery
Assessed via the Longitudinal Interval Follow-Up Evaluation (LIFE; lower is better)
Time frame: censored at 28 weeks, the proposed study duration
Overall perceived social support
Overall score of the Multidimensional Scale of Perceived Social Support (higher is better)
Time frame: 8, 16, and 28 weeks after intake
Dyadic social support (from partner or another important person)
Overall score of the Relationship Assessment Scale (higher is better)
Time frame: 8, 16, and 28 weeks after intake
Social role functioning (including parental functioning)
Overall score of the Short version of the Social Adjustment Scale (SAS) - Self Report and parental functioning SAS subscale (lower is better)
Time frame: 8, 16, and 28 weeks after intake
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Well-being
Overall score of the NIH Neuro-Quality of Life scale for positive affect and well-being (higher is better)
Time frame: 8, 16, and 28 weeks after intake
Grief symptoms
Overall score of the Perinatal Bereavement Grief Scale (lower is better)
Time frame: 8, 16, and 28 weeks after intake
Complicated grief symptoms
Overall score of the Inventory of Complicated Grief (lower is better)
Time frame: 8, 16, and 28 weeks after intake
Perceived deservingness of loss and guilt over loss
Loss Beliefs Scale (lower is better)
Time frame: 8, 16, an 28 weeks after intake
Fear of subsequent pregnancies
Overall score of the Fear of subsequent pregnancies measure (lower is better)
Time frame: 8, 16, and 28 weeks after intake