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

Sponsor
Utah State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06139718
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
3.7
Anticipated Duration (Months)
26.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ACT Guide Lite
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial Examining the Efficacy of a Single Session Online Mental Health Program
Anticipated Study Start Date :
Jan 8, 2024
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ACT Guide Lite

Those randomly assigned to the ACT condition after completing baseline assessment will be automatically directed to the registration for ACT Guide Lite. Participants in the ACT condition will be asked to complete the intervention at that time, but they will have the option to take a break before starting. If an ACT participant does not complete the intervention, they will be prompted to login by a research assistant.

Behavioral: ACT Guide Lite
ACT Guide Lite is a single session online mental health program that is designed to take 30-45 minutes to complete. The single session self-guided intervention includes a series of sections that teach key ACT skills.
Other Names:
  • Single session digital mental health intervention

    		•
    No Intervention: Waitlist control

    Participants assigned to the waitlist condition will be asked to simply wait to complete the scheduled 1-week and 1-month follow up assessments before accessing the intervention. After they complete the 1-month follow up assessment we will direct participants in the waitlist to access ACT Guide Lite, but at that point their participation in the study will be complete and we will not analyze their use of or responses to the program as part of the study aims.

    Outcome Measures

    Primary Outcome Measures

    1. CompACT [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 Outcome Measures

    1. Depression, Anxiety and Stress Scale (DASS-21) [baseline, 1-week follow-up, 1-month follow-up]

      ). This 21-item measure will be used to assess the subscales of depression, anxiety, and stress, with a total score representing overall psychological distress.

    2. Mental Health Continuum - Short Form (MHC-SF) [baseline, 1-week follow-up, 1-month follow-up]

      This 14-item measure assesses positive mental health, with a total score as well as subscales for emotional, psychological and social wellbeing.

    3. General Help Seeking Questionnaire (GHSQ) [baseline, 1-week follow-up, 1-month follow-up]

      We will use an adapted version of the GHSQ as a measure of intentions to seek help for a mental health concern. This includes rating a variety of formal (e.g., psychologist, PCP) and informal supports (e.g., friends, family) on a 7-point scale from 1 "extremely likely" to 7 "extremely unlikely." We previously adapted the GHSQ for a prior lab study (Levin et al., 2018) by adding options for self-help/online treatment resources and we have found this measure to be sensitive to detecting the effects of online ACT on increasing intentions to seek treatment (Davis, Donahue, et al., under review).

    4. Program satisfaction [1-week follow-up, 1-month follow-up]

      A series of program satisfaction items will be asked in the ACT condition immediately post-intervention and at 1-week and 1-month follow up based on items used in our previous online ACT trials (Levin et al., 2020). This will include a series of items assessing features of program satisfaction (e.g., overall satisfaction, helpfulness, perceived fit, if the program was too short or long, etc…) on a scale from 1 (strongly disagree) to 6 (strongly agree). In addition, participants will be asked to type responses to open ended questions assessing what they learned from the program and areas needing further revision.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 18 years or older

    • a current USU student

    • not have used any of the USU ACT Guide programs before

    Exclusion Criteria:
    • NA

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Utah State University Logan Utah United States 84322

    Sponsors and Collaborators

    • Utah State University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Michael Levin, Professor, Utah State University
    ClinicalTrials.gov Identifier:
    NCT06139718
    Other Study ID Numbers:
    • IRB: #13673
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 18, 2023