Clinical trial NCT04081662: Examining the Efficacy of Acceptance and Commitment Therapy (ACT) Microinterventions for Distressed First-Generation College Students
Official title: Examining the Efficacy of Acceptance and Commitment Therapy (ACT) Microinterventions for Distressed First-Generation College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psychological Distress
Self-Assessment
Mood Change
Keywords: Acceptance and commitment therapy
Micro-intervention
Mobile intervention
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 19
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of the ACT micro-intervention: percentage adherence to PHQ-2, PSS-4, and activity prompts
timeFrame: Day 1 - day 43
measure: Safety of ACT micro-intervention: Change in Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline, 3 months and 6 months post intervention
measure: Effectiveness of the ACT micro-intervention: proximal changes in mood outcomes as a result of intervention as indicated by self-reported activity of participant
timeFrame: Days 1-43
Secondary outcomes:
measure: Proximal changes in mood outcomes as a result of intervention: The Perceived Stress Scale (PSS-4) score
timeFrame: Days 1-43
measure: Proximal changes in mood outcomes as a result of intervention: Patient Health Questionnaire-2 (PHQ-2) score
timeFrame: Days 1-43
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References:
citation: 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.