Examining the Efficacy of a Single Session Online Mental Health Program

April 10, 2024 updated by: Michael Levin, Utah State University

A Randomized Controlled Trial 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Logan, Utah, United States, 84322
        • Recruiting
        • Utah State University
        • Contact:
        • Principal Investigator:
          • Michael Levin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 1-week follow-up, 1-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 1-week follow-up, 1-month follow-up
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.
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)
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).
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)
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.
1-week follow-up, 1-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Utah State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IRB: #13673

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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