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

NCT04081662 | Completed Phase 1

• 4 other identifiers: 2019-0819Biostat & MedA538900SMPH/PSYCHIATRY/PSYCHIATRY
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychological Distress; Self-Assessment; Mood Change

Keywords

Acceptance and commitment therapy; Micro-intervention; Mobile intervention

Outcome Measures

Primary Outcomes (3)

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

  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.

  Day 1 - day 43

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

  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

  Baseline, 3 months and 6 months post intervention

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

  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."

  Days 1-43

Secondary Outcomes (2)

• 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

Study Arms (1)

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.

Behavioral: compACT Intervention

Interventions

compACT Intervention BEHAVIORAL

The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of distress, depressive symptoms, and activity through the mobile app Lorevimo. Microintervention: 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). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.

compACT Intervention

Eligibility Criteria

• Age: 18 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Thomas EBK, Sagorac Gruichich T, Maronge JM, Hoel S, Victory A, Stowe ZN, Cochran A. Mobile Acceptance and Commitment Therapy With Distressed First-Generation College Students: Microrandomized Trial. JMIR Ment Health. 2023 May 15;10:e43065. doi: 10.2196/43065.

  PMID: 37184896 DERIVED

• Kroska EB, Hoel S, Victory A, Murphy SA, McInnis MG, Stowe ZN, Cochran A. Optimizing an Acceptance and Commitment Therapy Microintervention Via a Mobile App With Two Cohorts: Protocol for Micro-Randomized Trials. JMIR Res Protoc. 2020 Sep 23;9(9):e17086. doi: 10.2196/17086.

  PMID: 32965227 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a design known as a microrandomized trial. Whereas a multi-arm trial randomizes a subject to an intervention group only once at the start of the study, a microrandomized trial repeatedly randomizes a subject to an intervention group throughout the study. In addition to an overall effect of an intervention on proximal outcomes, a microrandomized trial allows one to determine if the effect is modified by momentary factors (e.g., current mood, day of the week, day in the study). For the present study, every subject has a equal chance of being assigned to one of two intervention groups at each of 84 time points (2 daily x 42 days). At each time point, the two intervention groups are to either receive a prompt based on Acceptance and Commitment Therapy (ACT) or not receive such a prompt. Regardless of the assigned group, subjects are asked to assess their mood, stress, and activity at every time point prior to assignment to intervention group.

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 9, 2019
• Study Start: October 18, 2019
• Primary Completion: November 20, 2020
• Study Completion: May 11, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)