- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01913366
Senior Peer Alliance for Rural Research On Wellness (SPARROW)
Case Management and Problem Solving Therapy for Depressed Older Adults
연구 개요
상세 설명
If you are eligible to participate in the study after completing the screening assessment, and if you choose to continue on, we will randomize you (like a flip of a coin) to receive either 12 weeks of case management combined with problem solving therapy (CM-PST) with a social worker or 12 weeks of self-guided problem solving therapy (SG-PST) with support from a senior peer counselor.
As part of your participation in the study you will participate in three 1.5 hour assessment interviews of psychological and neuropsychological functioning (similar to your screening assessment) prior to your first week of treatment (baseline), two weeks after your final session (week 14), and three months after your final session (week 24). Additionally, you will participate in three shorter assessment interviews of psychological functioning, which will be conducted at weeks 3 and 6. These assessments will take approximately 30-45 minutes.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
California
-
Sonora, California, 미국, 95370
- Catholic Charities Motherlode Office- Sonora
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Residence in rural Tuolumne, Calaveras, San Joaquin or Stanislaus Counties;
- Diagnosis: Major depression, unipolar (by SCID ascertained DSM-IV criteria);
- Severity of depression: A PHQ-9>10 or a 24-Item HDRS>19;
- Need for social services: CANE score> 2, i.e. at least one unmet need;
Exclusion Criteria:
- Psychotic depression by SCID-IV, i.e., presence of delusions;
- High suicide risk, i.e. intent or plan to attempt suicide in near future;
- Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression;
- Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV);
- History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (including bipolar disorder, hypomania, and dysthymia);
- Dementia: MMSE below 24 or clinical diagnosis of dementia by DSM-IV;
- Acute/severe medical illness (delirium, metastatic cancer, de-compensated cardiac, liver or kidney failure, stroke or myocardial infarction) 3 months prior to entry; or use of drugs causing depression, (steroids, reserpine, alphamethyl-dopa, tamoxiphen, vincristine);
- Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance (walking with a cane is not an exclusion criterion)
- Inability to speak English;
- Aphasia interfering with communication;
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 |
|---|---|
|
실험적: CM-PST
If you are assigned to CM-PST, you will be working with the same care manager from your introductory session.
The care manager will continue to work with you on your problem-solving plan.
Additionally, you will receive case management services.
|
|
|
실험적: SG-PST
If you are assigned to SG-PST, you will continue to work on your problem-solving plan, using the self-guided materials provided to you during the introductory session.
Additionally, you will be partnered with a senior peer counselor who will support you in your SG-PST efforts.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hamilton Rating Scale for Depression (HRSD)
기간: Baseline
|
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
|
Baseline
|
|
Hamilton Rating Scale for Depression (HRSD)
기간: Week 3
|
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
|
Week 3
|
|
Hamilton Rating Scale for Depression (HRSD)
기간: Week 6
|
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
|
Week 6
|
|
Hamilton Rating Scale for Depression (HRSD)
기간: Week 12
|
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
|
Week 12
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
기간: Week 0
|
Generic assessment instrument for health and disability
|
Week 0
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
기간: Week 3
|
Generic assessment instrument for health and disability
|
Week 3
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
기간: Week 6
|
Generic assessment instrument for health and disability
|
Week 6
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
기간: Week 12
|
Generic assessment instrument for health and disability
|
Week 12
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Brooke Hollister, Ph.D., University of California, San Francisco
- 수석 연구원: Patricia Arean, Ph.D., University of California, San Francisco
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- R01AG043584-01A1 (미국 NIH 보조금/계약)
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. .