ClinicalTrials.gg
CompletedNCT06139718Updated Mar 28, 2025

Examining the Efficacy of a Single Session Online Mental Health Program

An interventional study of ACT Guide Lite in Psychological Flexibility, Psychological Distress and Psychological Well-Being, sponsored by Utah State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.

Sponsored by Utah State University · Not applicable, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 654 studies in Psychological Well-Being with a site in United States — 188 open to participants now, 239 under way, 1 of them phase 3. Psychological Well-Being · United States.

Enrollment
379th of 572
61 · median 116
Started
2024
with 73 others
No phase
514 of 654
152 open now
Registered
406th of 654
by date

Among the 654 studies in Psychological Well-Being with a site in United States, this one is the 379th largest by enrollment of the 572 interventional ones that give a count, is one of 74 that started in 2024, is one of 514 with no phase, and was the 406th registered.

Psychological Well-Being

2,197 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.

Browse Psychological Well-Being studies →

Open to participants now

188 of the 654 studies in Psychological Well-Being with a site in United States are open now. Recruiting first, the newest first:

183 more — sign in →

All 188 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 654 studies in Psychological Well-Being with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Psychological Flexibility
  • Psychological Distress
  • Psychological Well-Being
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • NA
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralACT 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.

    Also known as: Single session digital mental health intervention

06

What researchers measure

Primary outcomes

  1. CompACT (to assess psychological flexibility)

    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.

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

Secondary outcomes

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

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

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

  2. Mental Health Continuum - Short Form (MHC-SF; to assess positive mental health)

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

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

  3. General Help Seeking Questionnaire (GHSQ; to assess intention to seek help for a mental heath concern)

    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).

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

  4. Program satisfaction (Responses to a series of single item Likert-scale items about satisfaction with the intervention)

    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.

    Time frame: 1-week follow-up, 1-month follow-up

07

Study locations

1 site
  • Utah State University
    Logan, Utah 84322, United States
08

References and documents

Publications

  • 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. PubMed 37855277 ↗
  • 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. PubMed 38190219 ↗
  • 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. PubMed 36608854 ↗
  • 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. PubMed 33868913 ↗
  • 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.
  • 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
  • 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.
  • 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. PubMed 15982151 ↗
  • 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. PubMed 36847182 ↗
  • 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. Erratum In: Behav Res Ther. 2023 Sep;168:104363. doi: 10.1016/j.brat.2023.104363. PubMed 36455430 ↗
  • 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.
  • 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.
  • 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. PubMed 27440189 ↗
  • 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. PubMed 32014692 ↗
  • 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. PubMed 24313693 ↗
  • 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.
  • Lovibond, S. H. & Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scales, (2nd ed.). Sydney: Psychology Foundation of Australia.
  • 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. PubMed 36925822 ↗
  • 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.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in May 2024, 4 months.

Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's 4 months is below that.

Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2023
First posted
Nov 18, 2023
StartActual
Jan 8, 2024
Primary completionActual
May 17, 2024
CompletionActual
May 17, 2024
Last update
Mar 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06139718
Lead sponsor
Utah State University
Responsible party
Michael Levin (Professor, Utah State University) — Principal investigator
First posted
Nov 18, 2023
Start date
Jan 8, 2024
Primary completion
May 17, 2024
Completion
May 17, 2024
Last update
Mar 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion