Cognitive Therapy for Suicidal Older Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in baseline suicidal ideation
研究概览
简要总结
The primary aim of the proposed study is to compare the efficacy of cognitive therapy (CT) with the efficacy of an enhanced usual care (EUC) intervention for reducing the rate of suicide ideation (SI) and the severity of depression and hopelessness among older men. The investigators expect that suicidal older men randomly assigned to the CT intervention condition will have a lower rate of SI during the follow-up period than participants assigned to the control condition.
详细描述
Older adult males have the highest suicide rate of any age group in the U.S. However, most research concerning treatments for suicide ideation and behavior has focused on adolescents and young adults. Very few treatments have been developed to reduce suicide ideation and behavior in men aged 50 and above. This study will assess the effectiveness of specialized cognitive therapy versus enhanced usual care in treating older men with suicide ideation.
Participants in this five-year study will be randomly assigned to receive either cognitive therapy or enhanced usual care. Participants will be identified within the VA Medical Center and the University of Pennsylvania Health System (UPHS) as having experienced suicide ideation in the past month. Cognitive therapy will be provided by Ph.D.-level therapists and will be geared specifically toward older men with suicidal tendencies. The enhanced usual care condition will consist of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by independent evaluators and study case managers. In addition, patients in the enhanced usual care condition will receive weekly telephone calls from the study therapists. These phone calls will be approximately 15-30 minutes in duration and their purpose will be to ensure patient safety and to provide some support. All participants will be assessed pre-treatment to attain baseline measures of suicide ideation, hopelessness, and depression. Study visits will occur at baseline and Months 1, 3, 6, 9, and 12 to assess suicide ideation. Self-report and clinician-administered measures will be used to assess participants' progress.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Suicidal intent or desire during the past month prior to the baseline interview as indicated by a score of 1 or higher on items 4 or 5 of the Scale for Suicide Ideation.
- •50 years of age or older
- •Able to speak English
- •Able to provide written informed consent
- •Able to attend study assessment and therapy sessions
- •Able to provide at least two verifiable contacts for tracking purposes
- •Able to function at an intellectual level to allow for the reliable completion of study assessments and participate in psychotherapy as indicated by a Mini-Mental Status Exam (MMSE) total score of 24 or higher and an Executive Interview (EXIT-25) total score of 14 or lower.
排除标准
- •Needed priority treatment for a substance use disorder as determined by the referring clinician.
- •Needed priority treatment for PTSD as determined by the referring clinician.
- •Taking antidepressant medication for less than one month, or if antidepressant medication has been changed in the last month as indicated by the Alexopolous "Composite Antidepressant Score" Scale.
结局指标
主要结局
Change in baseline suicidal ideation
时间窗: baseline, 1, 3, 6, 9, 12 months
次要结局
- Cognitive Executive Functioning(baseline, 1, 3, 6, 9, 12 months)
- reasons for living and dying(baseline, 1, 3, 6, 9, 12 months)
- perceived social support(baseline, 1, 3, 6, 9, 12 months)
- complicated grief(baseline, 1, 3, 6, 9, 12 months)
- hopelessness(baseline, 1, 3, 6, 9, 12 months)
- depression(baseline, 1, 3, 6, 9, 12 months)
- social problem solving skills(baseline, 1, 3, 6, 9, 12 months)
- quality of life(baseline, 1, 3, 6, 9, 12 months)