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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-18

Study Completion Date

2021-05-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Psychological Distress Self-Assessment Mood Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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compACT Intervention

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.

Group Type EXPERIMENTAL

compACT Intervention

Intervention Type 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.

Interventions

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compACT Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes