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临床试验/NCT04081662
NCT04081662已完成1 期

Examining the Efficacy of Acceptance and Commitment Therapy (ACT) Microinterventions for Distressed First-Generation College Students

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年10月18日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
36
试验地点
1
主要终点
Feasibility of the ACT micro-intervention: percentage adherence to PHQ-2, PSS-4, and activity prompts

研究概览

简要总结

This research study aims to evaluate the feasibility, safety, and effectiveness of a micro-randomized acceptance and commitment therapy-based (ACT-based) intervention that is delivered to distressed first-generation college students.

详细描述

The transition to college is associated with a number of changes in health behaviors and mental health functioning, with 50% of college students meeting criteria for a psychiatric disorder. In particular, first-generation college students may be at particular risk for increased stress and mental health difficulties. The development of effective psychotherapeutic interventions is essential in providing adequate care to young adults during the transitional years of college. Delivery of these interventions via acceptable and feasible modalities for this population is also of utmost importance so that utilization and engagement are prioritized. Brief interventions have been a point of emphasis in recent years from the perspective of patient and provider efficiency, as well as many studies indicating effectiveness of brief interventions in creating and sustaining clinical levels of change.

The current study seeks to evaluate the effectiveness of brief interventions delivered via a smartphone app, or "microinterventions", based in Acceptance and Commitment Therapy (ACT). ACT is a cognitive-behavioral therapy that seeks to promote psychological flexibility. ACT is transdiagnostic, meaning that it is designed to target human suffering, rather than a particular psychological or physical disorder. ACT targets experiential avoidance, which is the inability or unwillingness to make contact with painful experiences (e.g., thoughts, emotions, memories. Avoidance provides short-term relief, but exacerbates the long-term experience of the avoided stimulus in terms of intensity and duration. The microintervention in this study will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT. For example, one prompt is "Do your current actions align with what matters most to you?" Delivery of these prompts (e.g., whether and when to deliver which prompt) is randomized to allow for secondary analyses of optimal delivery of the microintervention in addition to primary analyses of its effectiveness.

研究设计

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

入排标准

年龄范围
18 Years 至 19 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Willing to provide informed consent.
  • •Willing to comply with all study procedures and be available for the duration of the study.
  • •Individuals 18-19 years of age.
  • •Individuals who are full-time freshman or sophomore students at the University of Wisconsin-Madison.
  • •Fluent in written English.
  • •Has access to a smartphone.
  • •First-generation college student.
  • •Significant subjective distress (endorses distress on at least 4 out of the past 7 days that interfered with functioning in screening survey).

排除标准

  • •Expected life expectancy <6 months.
  • •Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
  • •Not suitable for study participation due to other reasons at the discretion of the investigators.

研究组 & 干预措施

compACT Intervention

Experimental

At every time-point of the study, participants will complete self-reports of stress, (as measured by the PSS-4) distress (as measured by the PHQ-2), and activity through the mobile app Lorevimo. After completing these assessments, participants will be randomly assigned to either receive one additional ACT-based microintervention question or receive no additional question.

The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action).

The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness.

干预措施: compACT Intervention (Behavioral)

结局指标

主要结局

Feasibility of the ACT micro-intervention: percentage adherence to PHQ-2, PSS-4, and activity prompts

时间窗: Day 1 - day 43

The feasibility of the microintervention will be assessed by Adherence to prompts (defined as a response to at least 50% completion of prompt items per day). If subjects adhere to prompts over 60% of the days of the intervention period on average, the intervention will be considered feasible. The prompts considered will be the 2 questions from the PHQ-2, the 4 questions from the PSS-4, and the 4 questions from the activity assessment.

Safety of ACT micro-intervention: Change in Patient Health Questionnaire 9 (PHQ-9)

时间窗: Baseline, 3 months and 6 months post intervention

The analysis will look at the change in proportion of individuals who meet criteria for minor or major depression on the PHQ-9 between study start (measure taken at baseline assessment) to study end (measure taken at 6-month follow-up assessment). The Patient Health Questionnaire 9 (PHQ-9) is a multipurpose scale for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 will reflect the effect of intervention on the severity of depression. The PHQ-9 scores correlates with the depression severity as follows: 5 to 9- Minimal symptoms 10 to 14- Minor depression 15 to 19 Major depression, moderately severe \>20 Major depression, severe

Effectiveness of the ACT micro-intervention: proximal changes in mood outcomes as a result of intervention as indicated by self-reported activity of participant

时间窗: Days 1-43

The effectiveness of the ACT micro-intervention will be assessed by looking at the responses to the activity assessment in relation to whether or not a participant received a micro-intervention at the prior time-point. The activity questions of interest are as follows: 1. Since you \[woke this morning or last logged your symptoms\], how much energy was consumed by trying to get rid of unwanted feelings, thoughts, or other internal experiences (example: suppressing, distracting, avoiding)? 2. Since you \[woke this morning or last logged your symptoms\], how much energy was consumed by pursuing your values (example: making choices that align with who you want to be or who/what matters)? Both questions are answered using a scale of 0-6, where 0 = "none" and 6 = "all of my energy."

次要结局

  • Proximal changes in mood outcomes as a result of intervention: The Perceived Stress Scale (PSS-4) score(Days 1-43)
  • Proximal changes in mood outcomes as a result of intervention: Patient Health Questionnaire-2 (PHQ-2) score(Days 1-43)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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