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://clinicaltrials.gov/ct2/show/NCT04098497; ClinicalTrials.gov NCT04081662; https://clinicaltrials.gov/ct2/show/NCT04081662 International Registered Report Identifier (IRRID) DERR1-10.2196/17086

BackgroundMobile transdiagnostic therapies offer a solution to the challenges of limited access to psychological care. However, it is unclear if individuals can actively synthesize and adopt concepts and skills via an app without clinician support.AimsThe present study measured comprehension of and engagement with a mobile acceptance and commitment therapy (ACT) intervention in two independent cohorts. Authors hypothesized that participants would recognize that behaviors can be flexible in form and function and respond in an ACT process-aligned manner.MethodsMixed-methods analyses were performed on open-ended responses collected from initial participants (n = 49) in two parallel micro-randomized trials with: 1) first-generation college students (FGCSs) (n = 25) from a four-year public research university and 2) individuals diagnosed with bipolar disorder (BP) (n = 24). Twice each day over six weeks, participants responded to questions about mood and behavior, after which they had a 50-50 chance of receiving an ACT-based intervention. Participants identified current behavior and categorized behavior as values-based or avoidant. Interventions were selected randomly from 84 possible prompts, each targeting one ACT process: engagement with values, openness to internal experiences, or self-awareness. Participants were randomly assigned to either exploratory (10 FGCS, 9 BP) or confirmatory (15 FGCS, 15 BP) groups for analyses. Responses from the exploratory group were used to inductively derive a qualitative coding system. This system was used to code responses in the confirmatory group. Coded confirmatory data were used for final analyses.ResultsOver 50% of participants in both cohorts submitted a non-blank response 100% of the time. For over 50% of participants, intervention responses aligned with the target ACT process for at least 96% of the time (FGCS) and 91% of the time (BP), and current behavior was labeled as values-based 70% (FGCS) and 85% (BP) of the time. Participants labeled similar behaviors flexibly as either values-based or avoidant in different contexts. Dominant themes were needs-based behaviors, interpersonal and family relationships, education, and time as a cost.ConclusionsBoth cohorts were engaged with the app, as demonstrated by responses that aligned with ACT processes. This suggests that participants had some level of understanding that behavior can be flexible in form and function.

Background Mobile interventions promise to fill in gaps in care with their broad reach and flexible delivery. Objective Our goal was to investigate delivery of a mobile version of acceptance and commitment therapy (ACT) for individuals with bipolar disorder (BP). Methods Individuals with BP (n=30) participated in a 6-week microrandomized trial. Twice daily, participants logged symptoms in the app and were repeatedly randomized (or not) to receive an ACT intervention. Self-reported behavior and mood were measured as the energy devoted to moving toward valued domains or away from difficult emotions and with depressive d and manic m scores from the digital survey of mood in BP survey (digiBP). Results Participants completed an average of 66% of in-app assessments. Interventions did not significantly impact the average toward energy or away energy but did significantly increase the average manic score m (P=.008) and depressive score d (P=.02). This was driven by increased fidgeting and irritability and interventions focused on increasing awareness of internal experiences. Conclusions The findings of the study do not support a larger study on the mobile ACT in BP but have significant implications for future studies seeking mobile therapy for individuals with BP. Trial Registration ClinicalTrials.gov NCT04098497; https://clinicaltrials.gov/ct2/show/NCT04098497

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Background Extant gaps in mental health services are intensified among first-generation college students. Improving access to empirically based interventions is critical, and mobile health (mHealth) interventions are growing in support. Acceptance and commitment therapy (ACT) is an empirically supported intervention that has been applied to college students, via mobile app, and in brief intervals. Objective This study evaluated the safety, feasibility, and effectiveness of an ACT-based mHealth intervention using a microrandomized trial (MRT) design. Methods Participants (N=34) were 18- to 19-year-old first-generation college students reporting distress, who participated in a 6-week intervention period of twice-daily assessments and randomization to intervention. Participants logged symptoms, moods, and behaviors on the mobile app Lorevimo. After the assessment, participants were randomized to an ACT-based intervention or no intervention. Analyses examined proximal change after randomization using a weighted and centered least squares approach. Outcomes included values-based and avoidance behavior, as well as depressive symptoms and perceived stress. Results The findings indicated the intervention was safe and feasible. The intervention increased values-based behavior but did not decrease avoidance behavior. The intervention reduced depressive symptoms but not perceived stress. Conclusions An MRT of an mHealth ACT-based intervention among distressed first-generation college students suggests that a larger MRT is warranted. Future investigations may tailor interventions to contexts where intervention is most impactful. Trial Registration ClinicalTrials.gov NCT04081662; https://clinicaltrials.gov/show/NCT04081662 International Registered Report Identifier (IRRID) RR2-10.2196/17086