Kroska Emily B, Hoel Sydney, Victory Amanda, Murphy Susan A, McInnis Melvin G, Stowe Zachary N, Cochran Amy
Department of Psychological and Brain Sciences, University of Iowa, Iowa City, IA, United States.
Department of Psychiatry, University of Wisconsin-Madison, Madison, WI, United States.
JMIR Res Protoc. 2020 Sep 23;9(9):e17086. doi: 10.2196/17086.
Given gaps in the treatment of mental health, brief adaptive interventions have become a public health imperative. Transdiagnostic interventions may be particularly appropriate given high rates of medical comorbidity and the broader reach of transdiagnostic therapies. One such approach utilized herein is acceptance and commitment therapy (ACT), which is focused on increasing engagement with values, awareness, and openness to internal experiences. ACT theory posits that experiential avoidance is at the center of human suffering, regardless of diagnosis, and, as such, seeks to reduce unworkable experiential avoidance.
Our objective is to provide the rationale and protocol for examining the safety, feasibility, and effectiveness of optimizing an ACT-based intervention via a mobile app among two disparate samples, which differ in sociodemographic characteristics and symptom profiles.
Twice each day, participants are prompted via a mobile app to complete assessments of mood and activity and are then randomly assigned to an ACT-based intervention or not. These interventions are questions regarding engagement with values, awareness, and openness to internal experiences. Participant responses are recorded. Analyses will examine completion of assessments, change in symptoms from baseline assessment, and proximal change in mood and activity. A primary outcome of interest is proximal change in activity (eg, form and function of behavior and energy consumed by avoidance and values-based behavior) following interventions as a function of time, symptoms, and behavior, where we hypothesize that participants will focus more energy on values-based behaviors. Analyses will be conducted using a weighted and centered least squares approach. Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50).
Recruitment began on September 10, 2019, for the bipolar sample and on October 5, 2019, for the college sample. Participation in the study began on October 18, 2019.
This study examines an ACT-based intervention among two disparate samples. Should ACT demonstrate feasibility and preliminary effectiveness in each sample, a large randomized controlled trial applying ACT across diagnoses and demographics would be indicated. The public health implications of such an approach may be far-reaching.
ClinicalTrials.gov NCT04098497; https://clinicaltrials.gov/ct2/show/NCT04098497; ClinicalTrials.gov NCT04081662; https://clinicaltrials.gov/ct2/show/NCT04081662.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17086.
鉴于心理健康治疗存在差距，简短的适应性干预已成为一项公共卫生要务。考虑到医学共病率较高以及跨诊断疗法的广泛应用范围，跨诊断干预可能尤为合适。本文采用的一种方法是接受与承诺疗法（ACT），该疗法专注于增强对价值观的投入、意识以及对内在体验的开放性。ACT理论假定，无论诊断如何，经验性回避都是人类痛苦的核心，因此，该疗法旨在减少无效的经验性回避。
我们的目的是提供理论依据和方案，以检验通过移动应用程序在两个不同样本中优化基于ACT的干预措施的安全性、可行性和有效性，这两个样本在社会人口学特征和症状概况方面存在差异。
每天两次，通过移动应用程序提示参与者完成情绪和活动评估，然后将他们随机分配到基于ACT的干预组或非干预组。这些干预措施是关于对价值观的投入、意识以及对内在体验的开放性的问题。记录参与者的回答。分析将考察评估的完成情况、与基线评估相比症状的变化，以及情绪和活动的近期变化。一个主要的关注结果是干预后活动的近期变化（例如，行为的形式和功能以及回避行为和基于价值观行为所消耗的能量），它是时间、症状和行为的函数，我们假设参与者将把更多的精力集中在基于价值观的行为上。将使用加权和中心化最小二乘法进行分析。两个样本将同时进行，以评估在临床表现和社会人口学特征差异很大的人群中优化移动ACT的能力：双相情感障碍患者（n = 30）和苦恼的第一代大学生（n = 50）。
双相情感障碍样本于2019年9月10日开始招募，大学生样本于2019年10月5日开始招募。研究参与于2019年10月18日开始。
本研究在两个不同样本中考察了基于ACT的干预措施。如果ACT在每个样本中都证明具有可行性和初步有效性，那么将表明需要进行一项大规模的随机对照试验，在不同诊断和人口统计学特征中应用ACT。这种方法对公共卫生的影响可能是深远的。
ClinicalTrials.gov NCT04098497；https://clinicaltrials.gov/ct2/show/NCT04098497；ClinicalTrials.gov NCT04081662；https://clinicaltrials.gov/ct2/show/NCT04081662。
国际注册报告识别码（IRRID）：DERR1-10.2196/17086。
