외상 후 스트레스 장애 및 우울증 증상이 있는 퇴역 군인의 심리사회적 기능을 개선하기 위한 모바일 건강 개입
Posttraumatic stress disorder (PTSD) and depression are the two most common mental health conditions among Veterans. When Veterans experience both, there is a negative impact on their functioning, making it difficult to function at work or at home and socially with other people. Although talk therapies can result in improvements in functioning, they are difficult to access because there are limited clinicians who can provide them. As most US adults now own a smartphone, mobile apps are a way for Veterans to access content traditionally delivered through talk therapies at their own pace. This study will test a mobile app based on a trauma-informed talk therapy that has helped Veterans with PTSD and depression make large improvements in functioning, through learning skills to navigate emotions and relationships. Additionally, through answering brief surveys and enabling passive tracking on their smartphones, Veterans will see real-time information on their functioning and mental health and on potential benefits from using these skills.
연구 개요
상태
상세 설명
Veterans experience high rates of posttraumatic stress disorder (PTSD) and depression, which are frequently comorbid and result in difficulties with psychosocial functioning substantially greater than either disorder alone. Functioning difficulties in Veterans have not been adequately addressed by most existing psychotherapies for PTSD and depression because they often focus on symptom improvement and are highly resource-intensive, requiring the training and time of skilled providers. To address this gap, mobile health (mHealth) apps can serve as a widely accessible, standalone or adjunctive intervention to target psychosocial functioning among Veterans with comorbid PTSD and depression. This study focuses on the evaluation of a self-guided mHealth intervention based on Skills Training in Affective and Interpersonal Regulation (STAIR), an evidence-based psychotherapy that explicitly targets functioning improvements and also alleviates PTSD and depression symptoms among trauma survivors. As part of the intervention, real-time assessment (i.e., ecological momentary assessment and passive sensing) will be incorporated to support Veterans in monitoring their functioning, symptoms, and potential benefits from STAIR. The primary goal is to determine the feasibility and acceptability of this intervention (self-guided STAIR Coach with real-time assessment).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Haijing W Hallenbeck, PhD MA
- 전화번호: (650) 387-4116
- 이메일: haijing.hallenbeck@va.gov
연구 장소
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California
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Palo Alto, California, 미국, 94304-1207
- VA Palo Alto Health Care System, Palo Alto, CA
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연락하다:
- Haijing W Hallenbeck, PhD MA
- 전화번호: (650) 387-4116
- 이메일: haijing.hallenbeck@va.gov
-
수석 연구원:
- Haijing Wu Hallenbeck, PhD MA
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Veteran
- enrolled in VA care
- fluent in English
- able to provide informed consent
- own a smartphone or willing to use a study-provided smartphone
- have diagnoses of current posttraumatic stress disorder (PTSD) and major depressive disorder (MDD)
- willing to not begin another form of Skills Training in Affective and Interpersonal Regulation (STAIR) during the study
Exclusion Criteria:
- history of mania or psychosis
- current suicidal ideation with plan and intent to harm self
- acute intoxication from alcohol or other substances
- current or past experience with any form of STAIR
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: Self-Guided STAIR Coach with Real-Time Assessment
Participants randomized to this condition will receive two mobile apps. |
Two mobile apps to be used as one intervention package to support participants in their progress through STAIR (Skills Training in Affective and Interpersonal Regulation) with self-monitoring of symptoms and functioning |
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활성 비교기: Real-Time Assessment
Participants randomized to this condition will receive one mobile app. |
One mobile app to support participants in self-monitoring of symptoms and functioning |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Study Recruitment Rate
기간: Evaluated at end of trial (lasting approximately 2 years)
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Recruitment rate will be calculated as the number of participants who are eligible for the study divided by the number of screened participants. Target feasibility benchmark is 50%. |
Evaluated at end of trial (lasting approximately 2 years)
|
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Study Retention Rate
기간: Evaluated at end of trial (lasting approximately 2 years)
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Retention rate will be calculated as the number of participants who completed the full study divided by the total number of enrolled participants. Target feasibility benchmark is 70%. |
Evaluated at end of trial (lasting approximately 2 years)
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Study Engagement Rate
기간: Evaluated at end of trial (lasting approximately 2 years)
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Engagement rate will refer to the mean percentage of completed STAIR Coach training plan levels and completed EMA surveys. Target feasibility benchmark is 70%. |
Evaluated at end of trial (lasting approximately 2 years)
|
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Mobile Application Rating Scale User Version (uMARS)
기간: Post-treatment (i.e., 12 weeks after starting the trial)
|
App quality will be assessed through the Mobile Application Rating Scale User Version (uMARS). Total scores on the uMARS range from 1 to 5, with higher scores indicating higher quality. Target acceptability benchmark is a uMARS mean score of greater than or equal to 4 (indicating positive app quality). |
Post-treatment (i.e., 12 weeks after starting the trial)
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Client Satisfaction Questionnaire-8 (CSQ-8)
기간: Post-treatment (i.e., 12 weeks after starting the trial)
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Client satisfaction will be assessed through the Client Satisfaction Questionnaire-8 (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, with higher scores indicating higher satisfaction. Acceptability benchmark is a CSQ-8 mean score of greater than or equal to 24 (indicating general treatment satisfaction). |
Post-treatment (i.e., 12 weeks after starting the trial)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PTSD Checklist for DSM-5 (PCL-5)
기간: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
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PTSD symptoms will be assessed through the PTSD Checklist for DSM-5 (PCL-5). Total scores on the PCL-5 range from 0 to 80, with higher scores indicating greater PTSD symptoms. The focus will be on evaluating effect sizes and not statistical significance. Effect sizes will be inspected to see whether they are in the expected direction and larger for the intervention condition compared to the control condition. |
Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
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Patient Health Questionnaire-9 (PHQ-9)
기간: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
|
Depression symptoms will be assessed through the Patient Health Questionnaire-9 (PHQ-9). Total scores on the PHQ-9 range from 0 to 27, with higher scores indicating greater depression symptoms. The focus will be on evaluating effect sizes and not statistical significance. Effect sizes will be inspected to see whether they are in the expected direction and larger for the intervention condition compared to the control condition. |
Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
|
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World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
기간: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
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Psychosocial functioning impairment will be assessed through the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Total scores on the WHODAS 2.0 range from 0 to 144, with higher scores indicating greater functioning impairment. The focus will be on evaluating effect sizes and not statistical significance. Effect sizes will be inspected to see whether they are in the expected direction and larger for the intervention condition compared to the control condition. |
Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Haijing Wu Hallenbeck, PhD MA, VA Palo Alto Health Care System, Palo Alto, CA
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- D5318-W
- IK2RX005318-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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