- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02309060
Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial (sTVi-Open)
Narrative Intervention to Disseminate ACT for Depression in Primary Care
The overall aim of this program of research is to develop a collaborative narrative intervention for patients with depression being treated in primary care.
The purpose of the proposed project is to establish the feasibility, acceptability, and preliminary effects of our newly developed narrative intervention on depression.
To achieve the specific aims, the investigators will conduct an open trial to further develop and refine the intervention (n = 10).
연구 개요
상세 설명
The public health impact of existing treatments for major depression is limited by our ability to disseminate those treatments. There is a particular need to find innovative ways to disseminate key principles of empirically supported psychotherapy in primary care settings. Narrative communication is an alternative way to disseminate psychotherapy behavior change principles. Narrative communication refers to "storytelling" -real people talking about their struggles and successful ways of coping. An advantage of narrative communication is that it can be easily distributed (by video) and may reach people who do not have access to other technologies or who experience barriers to traditional psychotherapy. We propose that key principles of a type of cognitive-behavioral therapy (Acceptance and Commitment Therapy, or ACT) can be readily disseminated through a video storytelling intervention. ACT is an empirically supported therapy for depression. Together with a video production firm with a record of working in healthcare and developing documentary-style videos, we will produce a storytelling video intervention (sTVi).
Our aim is to conduct a small open trial (n = 10) of antidepressant medication treatment as usual + sTVi. Assessments will occur at baseline and 4 weeks (post-treatment). We will examine the feasibility and acceptability of sTVi (e.g., uptake and completion of sTVi, engagement with videos, and understanding of key ACT principles) and of this research design. We will examine treatment effects (within relevant confidence intervals) on outcomes (e.g., depression severity). We will examine change in potential mechanisms, i.e., ACT-consistent coping strategies derived from key ACT principles.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Rhode Island
-
Pawtucket, Rhode Island, 미국, 02860
- Family Care Center of Memorial Hospital
-
Providence, Rhode Island, 미국, 02906
- Butler Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Meets DSM-5 criteria for current or lifetime major depressive disorder.
- No Lifetime diagnosis of bipolar disorder, schizophrenia, or chronic psychotic condition.
- No current hazardous illicit drug or alcohol use.
- No suicidal ideation or behavior requiring immediate attention.
- Depression symptom severity: a Quick Inventory of Depressive Symptoms (QIDS) score >11.
- Taking an antidepressant medication for at least 6 weeks; prescribed by their primary care provider.
- Not in psychotherapy during the study period.
- Have a PCP at our enrollment site.
- If pregnant, less than 24 weeks gestation.
- English speaking.
- Aged 18 or older.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Storytelling Video Intervention (sTVi)
We will develop a series of 4 videos, each episode approximately 30 minutes long, which will illustrate the key principles of Acceptance and Commitment Therapy. We will add a short, non-narrative, epilogue at the end of each of the 4 episodes that summarizes key messages and provides information on identifying signs of depression and suggestions for efficacious treatments. In addition, we will develop an accompanying "personal journal" for participants that includes a brief self-help guide which encourages participants to write about what they learned in the videos and how they will take similar steps in their own lives to cope with depression. |
Narrative communication, video-based intervention for depressed primary care patients.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
고객 만족도 설문지-8(CSQ-8)
기간: 4 주
|
4 주
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Quick Inventory of Depressive Symptomatology-Clinician Rating (QIDS-C)
기간: 4 weeks
|
4 weeks
|
|
Acceptance and Action Questionnaire-II (AAQ-II)
기간: 4 week
|
4 week
|
공동 작업자 및 조사자
간행물 및 유용한 링크
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. .