Trial of a Positive Psychology Intervention to Reduce Suicide Risk in Patients With Major Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in BHS Scores
研究概览
简要总结
In this study, the investigators will perform an exploratory randomized trial of Positive Psychology (PP). The trial will consist of 50 participants and will compare the impact of a phone-based PP intervention vs. an attentional control condition, in Major Depressive Disorder (MDD) patients who are hospitalized for SI or following a suicide attempt. This is a 12 week trial with 6 weeks of intervention and two blinded follow-up assessments at 6 and 12 weeks.
Specific Aim #1: To assess the feasibility and acceptability of the phone-based PP intervention in this high-risk population.
Hypotheses: The intervention will be feasible (with most patients completing at least 4/6 PP and with follow-up data from at least 80% of subjects). The ratings of ease and subjective helpfulness of the exercise and other mental states as measured before and after each PP exercise will be more than 6 out of 10 and higher than the same ratings obtained from subjects in the control condition.
Specific Aim #2: To examine the impact of the six-session PP intervention on positive psychological well-being.
Hypothesis: Compared to control subjects, subjects randomized to PP will have greater scores on scales of optimism (measured via the Life Orientation Test-Revised [LOT-R]), gratitude (Gratitude Questionnaire-6 [GQ-6]), and positive affect (Positive Affect Negative Affect Schedule [PANAS]) at 6 and 12 weeks.
Specific Aim #3 (primary aim): To assess the impact of the PP intervention on key suicide risk factors.
Hypothesis: PP subjects will have greater scores on scales of hopelessness (Beck Hopelessness Scale [BHS]; primary study outcome measure), suicidal ideation (SI) (Concise Health Risk Tracking scale [CHRT]), and depression (Quick Inventory of Depressive Symptomatology-Self Report [QIDS-SR]) at 6 and 12 weeks.
We will also measure impact on readmission and suicide attempts to assess these key outcomes.
详细描述
Participants will be randomized to receive the intervention or recollection (control) arm. They will be randomized by a random-number generator and will be assigned a condition after receiving baseline questionnaires. The RA/blinded assessor will be blind to the study condition. The interventionist and subjects will not be blind to the study condition.
Baseline assessments: After consent and eligibility rule outs, subjects will receive baseline questionnaires to assess hopelessness (BHS46), suicidality (CHRT47), depression (QIDS-SR48), and positive states (LOT-R,43 GQ-6,44 PANAS45). Then, subjects will be randomized via random number generator to receive the control or intervention condition.
After completing baseline questionnaires and receiving randomization, subjects in both groups will have a 20 minute initial in-hospital session ("week #1"), within a week of anticipated discharge, in which the interventionist will provide a treatment manual specific to their condition, review the rationale for the initial exercise, and assign the exercise. The next day, the exercise will be reviewed and an exercise assigned for the next week. Immediately after completing the exercise, subjects will rate (on a Likert scale of 1-5) ease of exercise completion, overall utility, and initial impact on hopelessness/optimism, to assess immediate effects.
After discharge from the hospital, subjects will have five 20 minute weekly phone sessions ("weeks #2-6") with a different exercise used each week (assigned in the same order to all subjects). The phone sessions will include: (a) review of the prior week's exercise (including subject ratings of ease and impact as in week #1), (b) discussion of the rationale and assignment of the next week's exercise via a guided review of the study manual, and (c) completion of the Clinical Status questions and the Clinical Global Improvement scale (CGI) to monitor symptoms and improvement. Sessions will be audiotaped and random sessions reviewed by our PP consultant to ensure fidelity to the intervention (and that other techniques, e.g., Cognitive Behavioral Therapy, are not used).
Positive psychology (intervention condition)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted to Massachusetts General Hospital inpatient psychiatric unit
- •Age 18 and older
- •Able to read/write in English
- •SI documented on admission OR admission due to a suicide attempt
- •Admission diagnosis of MDD (and current major depressive episode), confirmed using the Mini International Neuropsychiatric Interview (MINI) and inpatient chart review
排除标准
- •Psychotic symptoms, as assessed using the MINI and inpatient chart review
- •Cognitive disorder, assessed using a six-item cognitive screen developed for research
- •Primary admission diagnosis of substance use disorder
研究组 & 干预措施
Positive Psychology
The Positive Psychology intervention consists of 6 exercises that will be completed by the participant with the guidance of a trainer.
Exercises:
Gratitude for positive events
Gratitude letter
Performing acts of kindness
Using personal strengths
Enjoyable and meaningful activities:
Repeating one of the previous exercises.
干预措施: Positive Psychology (Behavioral)
Organizational Skills
The Control Condition consists of 6 exercises that will be completed by the participant with the guidance of a trainer.
Exercises:
Daily Events
Health Events
Morning and Evening Events
Interactions with Others
Leisure Time Activities
Repeating one of the previous exercises.
干预措施: Control Condition (Behavioral)
结局指标
主要结局
Change in BHS Scores
时间窗: Baseline, 6 weeks, and 12 weeks
The Beck Hopelessness Scale (BHS) is a validated, twenty item, self-report measure that assesses three major aspects of hopelessness: feelings about the future, loss of motivation, and expectations.
次要结局
- Change in CHRT Scores(Baseline, 6 weeks, and 12 weeks)
- Change in QIDS-SR Scores(Baseline, 6 weeks, and 12 weeks)
研究者
Jeff C. Huffman, MD
Medical Director, Blake 11
Massachusetts General Hospital