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Clinical Trials/NCT06139718
NCT06139718
Completed
N/A

A Randomized Controlled Trial Examining the Efficacy of a Single Session Online Mental Health Program

Utah State University1 site in 1 country61 target enrollmentJanuary 8, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychological Flexibility
Sponsor
Utah State University
Enrollment
61
Locations
1
Primary Endpoint
CompACT (to assess psychological flexibility)
Status
Completed
Last Updated
last year

Overview

Brief Summary

There is a large body of evidence demonstrating that Acceptance and Commitment Therapy (ACT) can be delivered in a self-guided format to improve mental health among college students. However, previous research indicates there are challenges in engaging students in adhering to these time intensive, multi-session self-guided resources. Brief self-guided single session interventions could provide an accessible and acceptable intervention that is easier to adhere to, given their lower intensity and response effort for participation. This proposed study seeks to evaluate a single session online ACT Guide Lite intervention in a sample (n = 100) of Utah State University (USU) college students 18 years of age or older. A randomized controlled trial (RCT) design will be used in which students are randomized to receive ACT Guide Lite or to a waitlist condition in order to test the following predictions: (1) participants assigned to ACT Guide Lite will improve more on the primary therapeutic process of change, psychological flexibility, relative to those not receiving intervention, (2) participants assigned to ACT Guide Lite will improve more on distress, well-being, and interest in seeking help, relative to those not receiving intervention, (3) ACT Guide Lite will be acceptable to college students as indicated by recruitment rates, rates of completing ACT Guide Lite, and self-reported program satisfaction, and (4) areas for future program revisions will also be identified through participants' written feedback on their experiences using the program. USU students will be recruited to participate in the study through the SONA research platform in the Fall 2023 semester. All study procedures will be completed through the secure Qualtrics online research platform, in addition to email and phone contacts prompting relevant steps for the study. All analyses will be run with multilevel modeling with the full intent-to-treat sample to test time by condition interactions.

Registry
clinicaltrials.gov
Start Date
January 8, 2024
End Date
May 17, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Levin

Professor

Utah State University

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • a current USU student
  • not have used any of the USU ACT Guide programs before

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

CompACT (to assess psychological flexibility)

Time Frame: baseline, 1-week follow-up, 1-month follow-up

This 23-item measure will be used to measure the ACT process of change, psychological flexibility, including subscales for openness to experience, behavioral awareness, and valued action. The CompACT will serve as the primary outcome for this study in order to test whether a single session intervention is sufficient to target the ACT process of change of psychological flexibility.

Secondary Outcomes

  • Depression, Anxiety and Stress Scale (DASS-21)(baseline, 1-week follow-up, 1-month follow-up)
  • Program satisfaction (Responses to a series of single item Likert-scale items about satisfaction with the intervention)(1-week follow-up, 1-month follow-up)
  • Mental Health Continuum - Short Form (MHC-SF; to assess positive mental health)(baseline, 1-week follow-up, 1-month follow-up)
  • General Help Seeking Questionnaire (GHSQ; to assess intention to seek help for a mental heath concern)(baseline, 1-week follow-up, 1-month follow-up)

Study Sites (1)

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