Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Reduced time to remission from major depressive disorder (exploratory in this underpowered feasibility/acceptability study)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Group Interpersonal Psychotherapy (IPT-G)
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.
干预措施: Group Interpersonal Psychotherapy (IPT-G) (Behavioral)
Coping with Depression (CWD)
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.
干预措施: Coping with Depression (CWD) (Behavioral)
结局指标
主要结局
Reduced time to remission from major depressive disorder (exploratory in this underpowered feasibility/acceptability study)
时间窗: 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.
Treatment Acceptability
时间窗: Post Treatment (12 Weeks)
Treatment acceptability measured by the End of Treatment Questionnaire and the client satisfaction questionnaire.
Reduction in depressive symptoms (exploratory in this underpowered feasibility/acceptability study)
时间窗: 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.
次要结局
- Perceived Social Support(Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months)
- Grief(Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months)
- Couple Distress(Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months)
研究者
Dr. Jennifer Johnson
Associate Professor (Research)
Brown University