Cognitive Therapy for Suicidal Older Men
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Aaron T. Beck Psychopathology Research Center - University of Pennsylvania
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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.
- Male
- 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.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Cognitive Therapy
A cognitive therapy protocol specifically designed to target suicidal ideation in older adults.
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Cognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions.
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활성 비교기: Enhanced Usual Care
Enhanced usual care consists of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by project staff, and weekly phone calls provided by study therapists.
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Enhanced usual care (EUC) will consist of the usual care that individuals receive for suicide prevention in the community, assessment and referral services provided by study staff, and weekly telephone calls lasting 15-30 minutes provided by study therapists to ensure patient safety and to provide some support.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in baseline suicidal ideation
기간: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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depression
기간: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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hopelessness
기간: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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quality of life
기간: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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social problem solving skills
기간: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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complicated grief
기간: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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reasons for living and dying
기간: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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perceived social support
기간: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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Cognitive Executive Functioning
기간: baseline, 1, 3, 6, 9, 12 months
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Executive functioning will be measured by scores on an Executive Functioning Interview, which measures skills such as planning, working memory, attention, inhibition, and mental flexibility.
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baseline, 1, 3, 6, 9, 12 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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