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临床试验/NCT04861311
NCT04861311Unknown1 期

Testing the Efficacy of a Mindfulness- and Acceptance-Based Smartphone App Intervention for College Student Veterans With Posttraumatic Stress Disorder (PTSD): A Randomized Controlled Trial

University of Nevada, Las Vegas0 个研究点目标入组 64 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
64
主要终点
Resilience

研究概览

简要总结

The purpose of the study is to test the feasibility and acceptability of a mindfulness- and acceptance-based smartphone app (MABSA) intervention for college student veterans with posttraumatic stress disorder (PTSD) symptoms. The study will use a randomized controlled trial design of two groups: intervention group of about 30 participants with PTSD and wait-list control group of about 30 participants. The duration of the MABSA intervention is 6 weeks. The following are the outcomes to be measured: resilience, PTSD, mindfulness, experiential avoidance, and rumination.

详细描述

The objective of the proposed study is to evaluate the feasibility of the Mindfulness/Acceptance-Based Smartphone App (MABSA) intervention in a randomized controlled trial (RCT) environment and to obtain generalized information (i.e., initial efficacy, recruitment, retention, adherence, satisfaction, and usability of the refined intervention). The expected results will provide the foundation for a prospective, fully powered, larger-scale RCT study. We previously developed the MABSA and pilot tested it in a single-arm study. Our central hypothesis is that the refined MABSA intervention would improve intervention satisfaction, app usability, and adherence and positively affect resilience, PTSD, mindfulness, experiential avoidance, and rumination. The specific aims of the proposed study are outlined below.

AIM 1: To refine the previously developed MABSA intervention. The 6-week smartphone-delivered program will involve (1) daily audio-guided meditations on various mindfulness and acceptance exercises constructed based on the principles of acceptance and commitment therapy; (2) weekly support and feedback through phone calls and/or texting the intervention facilitators; and (3) ecological momentary assessment (daily monitoring of PTSD and resilience) to monitor the progression of treatment response (i.e., the trajectory of resilience and PTSD recovery). We will obtain qualitative feedback on program content and format through a pilot test of the prototype with a group of eligible college student veterans (N = 4). Upon revising the intervention based on participants' feedback, we will develop the intervention protocol manual for the RCT.

AIM 2: To test the feasibility and acceptability of the refined MABSA intervention in a small-scale RCT for a prospective, fully powered, larger-scale RCT study. The small-scale RCT study will involve the following two groups of college student veterans: (1) the MABSA intervention group (N = 30) and the waitlist control group (N = 30). Upon collecting the data on recruitment, retention, adherence, intervention satisfaction, and app usability, we will determine the preliminary efficacy based on the following five outcomes: resilience, PTSD, mindfulness, experiential avoidance, and rumination. Qualitative feedback on the facilitators of and challenges to recruitment, retention, and adherence will be collected via exit interviews.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) aged 18 years old or older, (2) currently registered as an undergraduate or graduate student, (3) has previous active military service from any U.S. military service branch, (4) has at least daily access to their own Apple iPhone (version 5 or later) or Android phone, and (5) have posttraumatic stress disorder (PTSD) symptoms (must have a score of 33 or above on the PTSD Checklist for DSM-5)

排除标准

  • (1) Those who have a score of 32 or below on the PTSD Checklist for DSM-5 and (2) Those who have a cognitive impairment such as dementia-related disorders.

研究组 & 干预措施

Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention Group

Experimental

The intervention is 6 weeks in duration. Participants will be asked to listen daily to at least one audio-guided mindfulness meditation embedded in the app. They will also be asked to watch a weekly video lesson on mindfulness and acceptance and will be asked to write a reflection about the video. They will also receive weekly emotional and technical support during the duration of the intervention.

干预措施: Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention (Behavioral)

Wait-List Control Group

No Intervention

The control group is a wait-list control group. Participants in the control group will be offered to use the app after 10 weeks of being in the study. The control group participants once they opted to use the app after 10 weeks will only have access to the app for 6 weeks.

结局指标

主要结局

Resilience

时间窗: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up

Changes in resilience based on the Connor-Davidson Resilience Scale 25

Rumination

时间窗: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up

Changes in rumination based on the Rumination Scale

PTSD

时间窗: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up

Changes in posttraumatic stress disorder (PTSD) symptoms based on the PTSD Checklist for DSM-5 (PCL-5)

Mindfulness

时间窗: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up

Changes in mindfulness based on the Mindfulness Attention and Awareness Scale

Experiential Avoidance

时间窗: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up

Changes in experiential avoidance based on the Acceptance and Action Questionnaire

次要结局

  • Resilience Progression(We will measure resilience daily using the app (ecological momentary assessment))
  • PTSD Recovery(We will measure PTSD daily using the app (ecological momentary assessment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Thomas Reyes

Assistant Professor

University of Nevada, Las Vegas

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