- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01648049
Treatment of Insomnia and Depression in Elders (TIDE) (TIDE)
Insomnia and depression are two of the most prevalent mental health disorders and often co-occur.
Health disparities in rural America and among African-Americans are well documented. The investigators propose an R34 exploratory project to test the feasibility of delivering high-fidelity insomnia and depression psychological services to an underserved population. Treatment of Insomnia and Depression in Elders (TIDE) is a pilot study that will treat rural, predominantly African-American older adults who present to their primary care physician with co-occurring insomnia/depression. Stage 1 will be an uncontrolled case study series (n = 10) focusing on treatment development/refinement and patient acceptability. In stage 2, feasibility will be experimentally tested with 46 participants randomized to integrated cognitive-behavior therapy (CBT) + usual care or to usual care only in an effectiveness pilot study. The treatment will combine/integrate compact CBT for insomnia (including relaxation, sleep restriction, and stimulus control) and for depression (including cognitive therapy and behavioral activation). The experimental intervention comprises delivering CBT services by videoconferencing to patients in primary care settings who live in rural areas. Treatment will be evaluated by pre, post, and follow-up self report instruments on insomnia, depression, and quality of life. In addition, the stage 1 pilot will use investigator designed quantitative and qualitative measures to evaluate critical process variables including patient acceptability of the video format, patient acceptability of the treatments, and obstacles to adherence. Depending on stage 1 data, these measures may be incorporated into stage 2 as well. Several innovative features of this exploratory project include: intervening with CBT on both disorders hoping to gain a synergy by their combined presentation; use of telehealth to deliver treatment to distant locations; translation of efficacy findings to an effectiveness trial; treatment will be delivered in the primary care setting, the preferred locale of rural, older adults; the study will extend knowledge of the range of CBT applications by enrolling under-represented groups with respect to ethnicity, literacy, and financial resources.
The primary aims of this project are (1) to determine the feasibility and maximal therapy characteristics of integrated CBT for co-occurring insomnia/depression in both the case study series (stage 1) and the experimental investigation (stage 2), (2) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in insomnia symptoms compared to participants receiving usual care at posttreatment and follow-up, and (3) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in depression symptoms compared to participants receiving usual care at posttreatment and follow-up.
연구 개요
상태
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Alabama
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Tuscaloosa, Alabama, 미국, 35487
- UATuscaloosa
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 50 years of age or older,
- resident of the Black Belt or adjacent counties and receiving services from one of our primary care collaborators
- absence of significant cognitive impairment as indicated by a score of 24 or higher (17 or higher for those with only an eighth grade education) on the Mini-Mental Status Examination (MMSE; Folstein, Folstein, & McHugh, 1975
- not currently receiving psychological treatment,
- absence of serious suicidality
- concurrent psychiatric/medical disorders are not automatic disqualifiers unless they prevent participants from attending CBT therapy sessions or impede data collection,
- a referral from their primary care physician indicating presence of both insomnia and depression symptoms of sufficient significance to warrant initiation or continuance of primary care treatment for newly emergent or residual symptoms. Persons who are currently receiving pharmacotherapy for insomnia and/or depression must evidence residual symptoms of both disorders of sufficient magnitude to be evaluated as clinically significant and warranting further treatment by their primary care physician.
Exclusion Criteria:
- age is below 50
- not receiving services from one of our primary care collaborators
- significant cognitive impairment is present as indicated by a score of 23 or lower (16 or lower for those with only an eighth grade education) on the MMSE
- currently receiving psychological treatment
- presence of serious suicidality
- intrusive and unstable concurrent psychiatric/medical disorders
- primary care physician declines to refer
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: CBT
Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy.
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CBT treatment is an abbreviated protocol based on manualized, evidence-based treatments for geriatric insomnia (Lichstein & Morin, 2000) and geriatric depression (Thompson, Gallagher-Thompson, & Dick, 1995).
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활성 비교기: Treatment as Usual
No additional treatment besides regular care.
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Standard Care - Treatment as usual
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Insomnia Severity Index
기간: 3-month follow-up (23weeks post-treatment)
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Insomnia Measure
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3-month follow-up (23weeks post-treatment)
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Hamilton Depression Scale
기간: 10 weeks Post-treatment
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Depression measure
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10 weeks Post-treatment
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Hamilton Depression Scale
기간: 3 Month follow-up (23 weeks post treatment)
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Depression Measure
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3 Month follow-up (23 weeks post treatment)
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Insomnia Severity Index
기간: 10 weeks Post-treatment
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Insomnia Measure
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10 weeks Post-treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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GDS
기간: Pre-Treatment (Baseline/Week 0)
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Self-reported Geriatric Depression Scale
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Pre-Treatment (Baseline/Week 0)
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SOL
기간: Pre-Treatment (Baseline/Week 0)
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self-reported Sleep Onset Latency
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Pre-Treatment (Baseline/Week 0)
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WASO
기간: Pre-Treatment (Baseline/Week 0)
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Wake-time After Sleep Onset
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Pre-Treatment (Baseline/Week 0)
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SOL
기간: 10 weeks Post-treatment
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Self-reported Sleep onset latency
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10 weeks Post-treatment
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SOL
기간: 3-month follow-up (23weeks post-treatment)
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Self-reported Sleep onset latency
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3-month follow-up (23weeks post-treatment)
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GDS
기간: 10 weeks Post-treatment
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Self Reported Geriatric Depression Scale
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10 weeks Post-treatment
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GDS
기간: 3-month follow-up (23weeks post-treatment)
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Self-reported Geriatric Depression Scale
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3-month follow-up (23weeks post-treatment)
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WASO
기간: 10 weeks Post-treatment
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Wake-time After Sleep Onset
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10 weeks Post-treatment
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WASO
기간: 3-month follow-up (23weeks post-treatment)
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Wake-time After Sleep Onset
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3-month follow-up (23weeks post-treatment)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kenneth L. Lichstein, Ph.D., University of Alabama, Tuscaloosa
- 수석 연구원: Forrest Scogin, Ph.D., University of Alabama, Tuscaloosa
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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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