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Completed

NCT Number: NCT06139718

Examining the Efficacy of a Single Session Online Mental Health Program

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Utah State University

Logan, Utah, 84322, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • NA

Treatment and study plan

ACT Guide Lite

Behavioral

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

Primary outcomes

  1. 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

  1. Depression, Anxiety and Stress Scale (DASS-21)

    Time frame: 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; to assess positive mental health)

    Time frame: 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; to assess intention to seek help for a mental heath concern)

    Time frame: 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 (Responses to a series of single item Likert-scale items about satisfaction with the intervention)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Utah State University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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