Optimizing an Acceptance and Commitment Therapy Microintervention Via a Mobile App With Two Cohorts: Protocol for Micro-Randomized Trials

Abstract

Background: 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.

Objective: 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.

Methods: 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).

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT04098497; https://ichgcp.net/clinical-trials-registry/NCT04098497; ClinicalTrials.gov NCT04081662; https://ichgcp.net/clinical-trials-registry/NCT04081662.

International registered report identifier (irrid): DERR1-10.2196/17086.

Keywords: acceptance and commitment therapy; bipolar disorder; clinical trial; mobile apps; mobile phone; students.

Conflict of interest statement

Conflicts of Interest: ZS has received research support from the NIH, the Centers for Disease Control and Prevention, GlaxoSmithKline (GSK), Pfizer, Wyeth, Janssen Pharmaceuticals, and Sage Therapeutics; has served on speaker or advisory boards for Pfizer, Eli Lilly, Wyeth, Sage Therapeutics, Bristol-Myers Squibb, and GSK; and has received honoraria from Eli Lilly, GSK, Pfizer, and Wyeth. MM has consulted with and/or received grant funding from Janssen Pharmaceuticals and Takeda Pharmaceuticals; he is a co-owner in Priori-AI, LLC.

©Emily B Kroska, Sydney Hoel, Amanda Victory, Susan A Murphy, Melvin G McInnis, Zachary N Stowe, Amy Cochran. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 23.09.2020.

Figures

Figure 1

The acceptance and commitment therapy (ACT) matrix. The ACT matrix encourages awareness of one’s values, internal experiences, and the function of one’s behaviors. The top two quadrants are observable behaviors, while the bottom two quadrants are internal experiences and not observable to others. The middle circle signifies the ability to notice each of these domains, categorizing all quadrants as part of a person’s experience.

Figure 2

Log functions of the Lorevimo app. The first screen (left) is where participants can set regular weekday and weekend wake times and bedtimes, which determines when they are prompted to log symptoms and activities. The second screen (center) is the mood symptoms log, including depression symptoms and perceived stress. The third screen (right) is the activity questionnaire.

Figure 3

Review function of the Lorevimo app. The first image (left) represents the top half of the acceptance and commitment therapy (ACT) matrix, which sorts the function of behaviors. The second image (right) represents the bottom half of the ACT matrix, which sorts internal experiences and values (ie, who or what matters).

Figure 4

Visualize function of the Lorevimo app. The images represent screenshots of the Lorevimo app’s Visualize function. The first image (left) is a representation of the depressive symptoms in a 3-day (twice daily) interval. The second image (center) conveys the perceived stress symptoms (also a 3-day interval). The final image (right) reflects the responses to the question about energy consumed by avoidance behaviors (ie, away from internal experiences) or values-based behaviors (ie, toward who or what matters).

Figure 5

Microintervention examples from the Lorevimo app. These images reflect three of the 84 acceptance and commitment therapy (ACT)-based intervention questions, also allowing space for participants to enter a response. The first (left) is an openness question, the second (center) an awareness question, and the third (right) an engagement question. CompACT: Comprehensive Assessment of Acceptance and Commitment Therapy Processes.