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单次叙事治疗研究

2026年9月3日 更新者:Akansha Vaswani Bye、University of Washington

单次叙事心理治疗干预的可行性、可接受性、适合性和临床影响的试点研究,以减少初级保健艾滋病诊所的等待时间

这项试点研究将通过提供单次叙事治疗干预来及时提供行为健康服务。 这项为期 6 个月的研究的目标是测试为艾滋病毒感染者提供服务的综合初级保健诊所的干预措施的可接受性、可行性和适合性。

研究概览

详细说明

单次干预旨在解决参与护理的障碍,并解决等待名单过长和提供者可用性有限的问题。 在转诊后立即提供单次干预是一种阶梯式护理连续模式的策略,已被发现是管理人群心理健康需求的有效方法。 本研究的目的是 1) 对目前在 HIV 初级保健诊所等待心理治疗服务的患者进行单次叙事治疗干预预试点,以评估患者对这种治疗方案的可接受性以及拟议数据收集的可行性2) 对同一干预措施进行为期 6 个月的试点研究,以评估干预措施的可接受性、适合性以及对服务和临床结果的影响。 在本研究结束时,将获得患者和提供者层面的数据,了解将单次心理治疗服务整合为综合护理环境中行为健康服务连续体的一部分的效用,研究人员可以利用这些数据来设计更大规模的实施效果试验。

研究类型

介入性

注册 (实际的)

64

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Washington
      • Seattle、Washington、美国、98104
        • Harborview Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

患者纳入标准

  • [Blinded] 诊所的患者的成年人(18 岁以上)
  • 已同意参加单次会议干预
  • 能够用英语完成采访和研究调查

患者排除标准:

  • 需要紧急心理健康治疗的参与者(例如,面临自杀或伤害他人的迫在眉睫的风险;无法出现症状)
  • 无法提供知情同意

提供商纳入标准:

  • 成人(18岁以上)
  • [盲]诊所的转诊提供者(社会工作者、初级保健医生、心理健康专业人员等)
  • 能够用英语完成研究调查或访谈。

提供商排除标准:

  • 无法提供知情同意
  • 非参考提供者

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:单次叙事治疗干预
将为 HIV 初级保健诊所心理治疗候补名单上的患者提供由经过培训的有执照的行为健康提供者进行的 60-75 分钟的叙事治疗课程。
单次叙事心理治疗干预是一种基于循证的阶梯式护理策略,可以帮助患者在最需要的时候获得护理,并可以最有效地利用稀缺资源。 它提供跨诊断、优势、以解决方案为导向、非病理化的干预措施,以满足患者的行为健康需求。
其他名称:
  • 简短叙事疗法

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Patient Health Questionnaire-9 (PHQ-9)
大体时间:1 month
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item validated self-report measure used to screen for depression, diagnose it, monitor its severity, and measure treatment response. The PHQ-9 ranges from 0 to 27 points, with higher scores reflecting more severe symptoms. Scores ≥ 10 indicate moderate depression. This measure was only collected and reported for patient participants.
1 month

次要结果测量

结果测量
措施说明
大体时间
Generalized Anxiety Disorder- 7 (GAD-7)
大体时间:1 month
The Generalized Anxiety Disorder 7-item (GAD-7) is a validated brief self-report tool that measures anxiety symptoms based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. The total score ranges from 0 to 21, with higher scores indicating greater severity. Scores ≥ 10 indicate moderate anxiety. This measure was only collected and reported for patient participants.
1 month
Remoralization Scale
大体时间:1 month
The Remoralization Scale is a validated 12-item self-report measure rated on a 4-point scale ranging from 1 ("Totally disagree") to 4 ("Totally agree") that assesses the level of remoralization. The total score ranges from 12 to 48, with higher scores indicating higher levels of remoralization. This measure was only collected and reported for patient participants.
1 month
Social Connectedness Scale-Original (SCS-Original)
大体时间:1 month
The Social Connectedness Scale is an 8-item instrument that assesses the degree to which one feels connected to others in their social environment. Items are measured on a 6-point Likert scale ranging from 1 ("Strongly Agree") to 6 ("Strongly Disagree"). Total scores range from 8 to 48 points. Higher total scores indicate a greater sense of social connectedness. This measure was only collected and reported for patient participants.
1 month
State-Trait Assessment of Resilience Scale (Trait Sub-scale Only)
大体时间:1 month
The State-Trait Assessment of Resilience Scale measures resilience using a state and trait approach, based on the conceptualization of resilience as being influenced by a combination of state and trait factors. This study will only measure the 'Trait' level of resilience, using the trait sub-scale (7-item instrument), which is construed as more distal and enduring. Items are measured on a 4-point Likert scale ranging from 1 ("Disagree") to 4 ("Strongly agree"). Total sum scores are calculated for the sub-scale and range from 7 to 28 points; higher scores reflect greater resilience. This measure was only collected and reported for patient participants.
1 month
Brief Services Evaluation
大体时间:1 month
The Brief Services Evaluation is a 6-item self-report measure assessing patients' perceptions of their skills, ideas, and knowledge related to the primary problem that brought them to counseling. Items are rated on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"). Item-level score totals range from 1 to 6. We report item-level changes and significance levels consistent with the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session. This measure was only collected and reported for patient participants.
1 month
Acceptability of Intervention Measure (AIM)
大体时间:1 Month for patient participants; 0 Month for referring providers
The Acceptability of Intervention Measure is a 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale 1 ("Completely Disagree") to 5 ("Completely Agree"). Score is a calculated mean that ranges from 1-5. Higher mean scores indicating greater perceived intervention acceptability.
1 Month for patient participants; 0 Month for referring providers
Intervention Appropriateness Measure (IAM)
大体时间:0 Month for referring providers
The Intervention Appropriateness Measure is a 4-item measure of perceived intervention appropriateness. Items are measured on a 5-point Likert scale 1 ("Completely Disagree") to 5 ("Completely Agree"). Score is a calculated mean that ranges from 1-5. Higher mean scores indicating greater perceived intervention acceptability.
0 Month for referring providers
Feasibility of Intervention Measure (FIM)
大体时间:0 Month for referring providers
The Feasibility of Intervention Measure is a 4-item measure of perceived intervention feasibility. Items are measured on a 5-point Likert scale 1 ("Completely Disagree") to 5 ("Completely Agree"). Score is a calculated mean that ranges from 1-5. Higher mean scores indicating greater perceived intervention feasibility.
0 Month for referring providers

其他结果措施

结果测量
措施说明
大体时间
Waitlist Evaluation Questionnaire
大体时间:0 Month
A 2-item questionnaire evaluating: a) if a patient would like to remain or be taken off the psychotherapy waitlist of [Blinded] clinic (yes or no) b) if the patient selects to remain on the waitlist, what service type they are seeking (Up to 3 single sessions scheduled when needed or 12-16 regularly scheduled sessions). This measure was only collected and reported for patient participants.
0 Month
Modified Single Session Impressions and Feedback Tool- Adapted Version
大体时间:0 month
The Single Session Impressions and Feedback tool is an 8-item post-session questionnaire which measures patient satisfaction and the degree to which the therapist adhered to key single session narrative therapy principles during the session. Items are measured a 7-point Likert scale from "1" (Strongly Disagree) to "7" (Strongly Agree) with the exception of the final item which is open-entry. Item level scores are reported. Item scores range from 1 to 7. Higher scores indicate greater patient satisfaction and therapist adherence to the intervention. As the SSIFT was designed as a therapist feedback tool, its psychometric properties have not been reported. The measure was only collected and reported for patient participants immediately after their first SSNT encounter.
0 month
Single Session Consultation Feedback Form
大体时间:0 month
The Single Session Consultation Feedback Form is a 5-item post-session questionnaire that measures patients' satisfaction with the therapy intervention. Items are measured on a Likert scale from 1 ("Not at all") to 5 ("Very much") with the exception of the final item which is open-entry. A higher score indicates greater satisfaction with the intervention. This measure was only collected and reported for patient participants.
0 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Akansha Vaswani-Bye、University of Washington

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年6月4日

初级完成 (实际的)

2025年5月15日

研究完成 (实际的)

2025年5月15日

研究注册日期

首次提交

2024年6月15日

首先提交符合 QC 标准的

2024年6月23日

首次发布 (实际的)

2024年6月28日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2025年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • STUDY00018612
  • 5P30MH123248-03 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

研究对象的去识别化数据将通过国家心理健康研究所数据档案馆 (NDA) 共享。

IPD 共享时间框架

数据将按照国家心理健康研究所数据档案馆要求的首次数据提交日期提供。

IPD 共享访问标准

有关 NDA 中共享数据的摘要信息可在 NDA 查询工具中获取,无需 NDA 用户帐户。 要请求访问记录级人类受试者数据,必须提交数据访问请求。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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