Preventing Chronic Depression and PTSD in Stroke Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Family Caregivers
2018년 8월 15일 업데이트: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
Preventing Chronic Depression and PTSD in Patients With Stroke Admitted to the Neuroscience ICU and Their Family Caregivers
The current study has the following objectives:
- To determine additional stroke patient (SP) and stroke caregiver (SC) factors including their perceptions of the stroke experience, hospitalization, and how they cope with its challenges; identify additional appropriate points to intervene (maladaptive coping styles, unrealistic expectations, inappropriate prioritization, misinformation about illness, and self care), and assess SP and SC preferences for the structure, mode of delivery (including potential for phone, video or a combination of these) and timing of an intervention.
- To develop, [using the preliminary data and information from aim 1], and test the feasibility and acceptability (primary outcomes) of a skills-based intervention for preventing chronic depression, anxiety, PTSD and decreased QoL in dyads at risk.
연구 개요
연구 유형
중재적
등록 (실제)
15
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Eligible dyads (stroke patients and stroke caregivers) must meet the following inclusion criteria:
- Age 18 or older
- English fluency and literacy
- Hospitalized with an acute stroke (hemorrhagic and ischemic) within the past 2 weeks (patient) OR primary stroke caregiver of a stroke patient currently admitted with an acute stroke
- Stroke patient or stroke caregiver screens in for depression and/or PTSD
One or more of the following exclusion criteria will render a stroke patient (only) ineligible:
- Stroke patients who cannot participate due to the severity of stroke, cognitive impairment and/or aphasia, and are anticipated to not be able to participate due to permanent impairment as judged by the medical team.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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: Psychosocial Skills-Based Intervention
Based on information from Phase I (semi-structured interviews), the investigators will develop a detailed psychosocial intervention manual.
The intervention will be tailored consistent with American Heart Association (AHA) recommendations for stroke skills based interventions and will include 2 general and 4 specific modules (selected from 7 available).
Generally, in the intervention, stroke patients and stroke caregivers will learn skills to cope and manage stroke-related stressors.
It is anticipated that the intervention will have 6 sessions with 2 general sessions delivered within the NICU face to face and 4 tailored specific sessions to be delivered via live video using Vidyo.
Participants in the intervention group will also receive treatment as usual.
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Subjects will attend group skills-based sessions once weekly (either in-person or via Vidyo) for 6 weeks and learn skills to cope and manage stroke-related stressors.
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간섭 없음: Minimally Enhanced Usual Care (MEUC)
Those in the MEUC will continue with their current care.
This may include meeting with nurses, physical therapist, medical doctors, and other members of the stroke patient's medical team.
Treatment as usual may also involve administration of Selective Serotonin Reuptake Inhibitors (SSRIs) to those patients with motor problems.
They will also received a pamphlet with educational information on stroke and recovery
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility of the Intervention
기간: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Demonstration of feasibility will be assessed by the number of individuals who drop out of the study prior to completing the post- intervention assessment and the rate of missed sessions.
If drop-out rate or missed-session rate exceeds 25%, revisions to the intervention may be needed.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Client Satisfaction Questionnaire (CSQ-8)
기간: Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures how satisfied the participant is with the intervention.
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Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Measure of Current Status (MOCS-A)
기간: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Cognitive and Affective Mindfulness Scale (CAMS)
기간: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures the degree to which individuals experience their thoughts and feelings.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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World Health Organization QOL Questionnaire (WHOQOL-BREF)
기간: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Modified Rankin Scale (mRS)
기간: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures the patient's prior stroke status and stroke severity.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Hospital Anxiety and Depression Scale (HADS)
기간: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures symptoms of anxiety and depression.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Posttraumatic Stress (PCL-S)
기간: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures symptoms of posttraumatic stress disorder
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Current psychotropic meds and comorbid medical conditions,
기간: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Study staff will collect information on patient's medical history and current medications to measure their mental health throughout the study.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Barthel Index
기간: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures the patient's prior stroke status and stroke severity.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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중환자실 내 환자/간병인의 연령, 성별, 인종, 민족, 결혼 여부, 학력 및 고용 상태
기간: 기준선(주 0)
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이 설문지는 ICU 환자/간병인에게 지난 12개월 동안 연령, 성별, 인종, 민족, 결혼 상태, 최고 교육 수준 및 주요 고용 상태를 보고하도록 요청합니다.
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기준선(주 0)
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신뢰성 설문지
기간: 기준선(주 0)
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참가자가 개입이 효과가 있다고 믿는 정도를 측정합니다.
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기준선(주 0)
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Prior Mental Health Questionnaire
기간: Baseline (week 0)
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This questionnaire asks ICU patients/caregivers to report any previous or current mental health conditions that they have been diagnosed with in the past.
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Baseline (week 0)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 7월 1일
기본 완료 (실제)
2018년 6월 1일
연구 완료 (실제)
2018년 8월 1일
연구 등록 날짜
최초 제출
2016년 6월 2일
QC 기준을 충족하는 최초 제출
2016년 6월 7일
처음 게시됨 (추정)
2016년 6월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 8월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 8월 15일
마지막으로 확인됨
2018년 8월 1일
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. .