Examining the Efficacy of a Single Session Online Mental Health Program

NCT ID: NCT06139718

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2024-05-17

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.

Conditions

Psychological Flexibility; Psychological Distress; Psychological Well-Being

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ACT Guide Lite

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Single session digital mental health intervention

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

• NA

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Utah State University

OTHER

Sponsor Role: lead

Responsible Party

Michael Levin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Utah State University

Logan, Utah, United States

Countries

United States

References

Davis CH, Donahue ML, Gaudiano BA, Uebelacker LA, Twohig MP, Levin ME. Adding online storytelling-based acceptance and commitment therapy to antidepressant treatment for primary care patients: a randomized clinical trial. Cogn Behav Ther. 2024 Jan;53(1):48-69. doi: 10.1080/16506073.2023.2265560. Epub 2024 Jan 2.

Reference Type: BACKGROUND

PMID: 37855277 (View on PubMed)

Davis CH, Klimczak K, Aller TB, Twohig MP, Levin ME. Reach, adoption, and maintenance of online acceptance and commitment therapy at a university: An implementation case study. Psychol Serv. 2024 May;21(2):355-361. doi: 10.1037/ser0000834. Epub 2024 Jan 8.

Reference Type: BACKGROUND

PMID: 38190219 (View on PubMed)

Davis CH, Twohig MP, Levin ME. Choosing ACT or CBT: A preliminary test of incorporating client preferences for depression treatment with college students. J Affect Disord. 2023 Mar 15;325:413-420. doi: 10.1016/j.jad.2022.12.097. Epub 2023 Jan 4.

Reference Type: BACKGROUND

PMID: 36608854 (View on PubMed)

Dochat C, Wooldridge JS, Herbert MS, Lee MW, Afari N. Single-Session Acceptance and Commitment Therapy (ACT) Interventions for Patients with Chronic Health Conditions: A Systematic Review and Meta-Analysis. J Contextual Behav Sci. 2021 Apr;20:52-69. doi: 10.1016/j.jcbs.2021.03.003. Epub 2021 Mar 6.

Reference Type: BACKGROUND

PMID: 33868913 (View on PubMed)

Firestone, J., Cardaciotto, L., Levin, M.E., Goldbacher, E., Vernig, P. & Gambrel, L.E. (2019). A web-based self-guided program to promote valued-living in college students: A pilot study. Journal of Contextual Behavioral Science, 12, 29-38.

Reference Type: BACKGROUND

Francis, A. W., Dawson, D. L., & Golijani-Moghaddam, N. (2016). The development and validation of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of Contextual Behavioral Science, 5(3), 134-145. doi:10.1016/j.jcbs.2016.05.003

Reference Type: BACKGROUND

Henriques, C.A., Cardaciotto, L., Levin, M.E. & Armstrong, S.L. (2020). Implementing a web-based cognitive defusion program to target negative self-referential thoughts in college students: A pilot study. Journal of Contextual Behavioral Science, 16, 183-191.

Reference Type: BACKGROUND

Keyes CL. Mental illness and/or mental health? Investigating axioms of the complete state model of health. J Consult Clin Psychol. 2005 Jun;73(3):539-48. doi: 10.1037/0022-006X.73.3.539.

Reference Type: BACKGROUND

PMID: 15982151 (View on PubMed)

Klimczak KS, San Miguel GG, Mukasa MN, Twohig MP, Levin ME. A systematic review and meta-analysis of self-guided online acceptance and commitment therapy as a transdiagnostic self-help intervention. Cogn Behav Ther. 2023 May;52(3):269-294. doi: 10.1080/16506073.2023.2178498. Epub 2023 Feb 27.

Reference Type: BACKGROUND

PMID: 36847182 (View on PubMed)

Klimczak KS, Twohig MP, Peacock GG, Levin ME. Using peer-support coaching to improve adherence to online ACT self-help for college mental health: A randomized controlled trial. Behav Res Ther. 2023 Jan;160:104228. doi: 10.1016/j.brat.2022.104228. Epub 2022 Nov 13.

Reference Type: BACKGROUND

PMID: 36455430 (View on PubMed)

Krafft, J., Twohig, M.P., & Levin, M.E. (2020). A randomized trial of acceptance and commitment therapy and traditional cognitive-behavioral therapy self-help books for social anxiety. Cognitive Therapy and Research, 44, 954-966.

Reference Type: BACKGROUND

Levin, M.E., An, W., Davis, C. & Twohig, M.P. (2020). Evaluating acceptance and commitment therapy and mindfulness-based stress reduction self-help books for college student mental health. Mindfulness, 11, 1275-1288.

Reference Type: BACKGROUND

Levin ME, Haeger JA, Pierce BG, Twohig MP. Web-Based Acceptance and Commitment Therapy for Mental Health Problems in College Students: A Randomized Controlled Trial. Behav Modif. 2017 Jan 1;41(1):141-162. doi: 10.1177/0145445516659645. Epub 2016 Jul 20.

Reference Type: BACKGROUND

PMID: 27440189 (View on PubMed)

Levin ME, Krafft J, Hicks ET, Pierce B, Twohig MP. A randomized dismantling trial of the open and engaged components of acceptance and commitment therapy in an online intervention for distressed college students. Behav Res Ther. 2020 Mar;126:103557. doi: 10.1016/j.brat.2020.103557. Epub 2020 Jan 22.

Reference Type: BACKGROUND

PMID: 32014692 (View on PubMed)

Levin ME, Pistorello J, Seeley JR, Hayes SC. Feasibility of a prototype web-based acceptance and commitment therapy prevention program for college students. J Am Coll Health. 2014;62(1):20-30. doi: 10.1080/07448481.2013.843533.

Reference Type: BACKGROUND

PMID: 24313693 (View on PubMed)

Levin, M. E., Stocke, K., Pierce, B., & Levin, C. (2018). Do college students use online self-help? A survey of intentions and use of mental health resources. Journal of College Student Psychotherapy, 32(3), 181-198.

Reference Type: BACKGROUND

Lovibond, S. H. & Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scales, (2nd ed.). Sydney: Psychology Foundation of Australia.

Reference Type: BACKGROUND

Schleider JL, Beidas RS. Harnessing the Single-Session Intervention approach to promote scalable implementation of evidence-based practices in healthcare. Front Health Serv. 2022 Sep 23;2:997406. doi: 10.3389/frhs.2022.997406. eCollection 2022.

Reference Type: BACKGROUND

PMID: 36925822 (View on PubMed)

Wilson, C.J., Deane, F.P., Ciarrochi, J. & Rickwood, D. (2005). Measuring help-seeking intentions: Properties of the General Help-Seeking Questionnaire. Canadian Journal of Counselling, 39(1), 15-28.

Reference Type: BACKGROUND

Other Identifiers

IRB: #13673

Identifier Type: -

Identifier Source: org_study_id