Major Depressive Disorder, Miscarriage, Neonatal Death, Stillbirth
Conditions
Keywords
Major Depressive Disorder (MDD), Miscarriage, Stillbirth, Neonatal death, Interpersonal psychotherapy, Group Therapy, Coping with Depression (CWD)
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.
Interventions
BEHAVIORALCoping with Depression (CWD)
Sponsors
National Institute of Mental Health (NIMH)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Acceptability | Post Treatment (12 Weeks) | 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) | 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. |
| Reduction in depressive symptoms (exploratory in this underpowered feasibility/acceptability study) | 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
| Measure | Time frame | Description |
|---|---|---|
| Perceived Social Support | 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. |
| Couple Distress | 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. |
| Grief | 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. |
Countries
United States
Outcome results
None listed