InsomniaNCT06094751
An ACT Website for College Students With Insomnia
A study testing ACT Guide for Insomnia in people with Insomnia, run by Utah State University at 1 site in United States.
Trial summary
College students experience higher rates of insomnia compared the general population, and accessibility and availability for the appropriate intervention is difficult due limited resources available to them in a college environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- ACT Guide for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- enrolled in a 2- or 4-year college (includes graduate students)
- fluent in English
- have access to the internet
- meets diagnosis for at least acute insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5
- searching/wanting in treatment
- currently residing in the US
Who cannot join
- diagnosed with another sleep disorder that is not insomnia
- currently attending therapy for an emotional disorder (anxiety or depression) or insomnia
- prescribed medications to treat insomnia or another sleep-inducing medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online ACT Guide for Sub-clinical and Clinical Insomnia Among College Students
College students experience higher rates of insomnia compared the general population, and accessibility and availability for the appropriate intervention is difficult due limited resources available to them in a college environment. Theorefore, it is vital to offer an intervention that can be just as effective yet more accessible than other available treatments targeting insomnia. That is why this study will investigate the efficacy and feasibility of an online ACT intervention for insomnia among college students. Specifically, Is an online ACT for college students effective in treating insomnia? And, is an online ACT for college students feasible and acceptable in treating insomnia? Participants will be randomized into one of two conditions: waitlist or online ACT guide. Participants will receive questionnaires at baseline, post-treatment (4 weeks), and 1-month follow up.
- Conditions
- Insomnia
- Being tested
- ACT Guide for Insomnia
- Keywords
- Insomnia, college student, university student, online
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT Guide for InsomniaBehavioural
ACT Guide for Insomnia includes 2 modules. Module 1 will include sleep/insomnia education, ACT skills (acceptance, defusion), and behavioral change. Module 2 will include sleep restriction, sleep hygiene, ACT skills (values, committed action), and behavioral change.
| Study group | Role | What they receive |
|---|---|---|
| ACT Guide for Insomnia | Experimental | Participants will complete 2 modules of an online Acceptance and Commitment Therapy (ACT) Guide designed to focus on insomnia among college students. Module 1 will be available to participants at the start of week 1 and throughout the course of the study. Module 2 will become available at the start of week 3 and participants will have access throughout the study Receives: Behavioral: ACT Guide for Insomnia |
| Waitlist | No intervention | Participants randomized into the waitlist condition will not have access to the ACT Guide for Insomnia until the conclusion of their time in the study (8 weeks after randomization). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
The ISI is composed of 7-items that asses for severity of sleep onset, sleep maintenance, early morning waking issues, sleep satisfaction, sleep interference (e.g., daytime fatigue), noticeability of sleep impairment, and sleep worry. Each item is measured on a five-point likert scale ranging from 0 indicating no severity to 4 indicating very severe. The ISI has been shown to be a valid, clinical questionnaire designed to gauge insomnia severity (Bastien, Vallières, \& Morin, 2001), is sensitive to treatment response (Morin, Belleville, Bélanger, \& Ivers, 2011), and has been agreed upon as essential for insomnia treatment efficacy studies (Buysse, Ancoli-Israel, Edinger, Lichstein, \& Morin, 2006). Additionally, the ISI has been used a previous randomized control trails (RCT) among college student to determine treatment efficacy (Taylor et al., 2014).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start20 Oct 2023
- Primary completion15 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Twohig, Ph.D., Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094751
- Sponsor's protocol ID
- 13376
- Status last verified
- Jul 2026
- First submitted
- 16 Oct 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online ACT Guide for Sub-clinical and Clinical Insomnia Among College Students
- ClinicalTrials.gov ID
- NCT06094751
- Acronym / sponsor ID
- 13376
- Conditions
- Insomnia
- Keywords
- Insomnia, college student, university student, online
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
College students experience higher rates of insomnia compared the general population, and accessibility and availability for the appropriate intervention is difficult due limited resources available to them in a college environment. Theorefore, it is vital to offer an intervention that can be just as effective yet more accessible than other available treatments targeting insomnia. That is why this study will investigate the efficacy and feasibility of an online ACT intervention for insomnia among college students. Specifically, Is an online ACT for college students effective in treating insomnia? And, is an online ACT for college students feasible and acceptable in treating insomnia? Participants will be randomized into one of two conditions: waitlist or online ACT guide. Participants will receive questionnaires at baseline, post-treatment (4 weeks), and 1-month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT Guide for Insomnia | Experimental | Behavioral: ACT Guide for InsomniaParticipants will complete 2 modules of an online Acceptance and Commitment Therapy (ACT) Guide designed to focus on insomnia among college students. Module 1 will be available to participants at the start of week 1 and throughout the course of the study. Module 2 will become available at the start of week 3 and participants will have access throughout the study |
| Waitlist | No intervention | –Participants randomized into the waitlist condition will not have access to the ACT Guide for Insomnia until the conclusion of their time in the study (8 weeks after randomization). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- enrolled in a 2- or 4-year college (includes graduate students)
- fluent in English
- have access to the internet
- meets diagnosis for at least acute insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5
Key exclusion criteria (3 listed)
- diagnosed with another sleep disorder that is not insomnia
- currently attending therapy for an emotional disorder (anxiety or depression) or insomnia
- prescribed medications to treat insomnia or another sleep-inducing medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT Guide for InsomniaACT Guide for Insomnia includes 2 modules. Module 1 will include sleep/insomnia education, ACT skills (acceptance, defusion), and behavioral change. Module 2 will include sleep restriction, sleep hygiene, ACT skills (values, committed action), and behavioral change. | Behavioural | ACT Guide for Insomnia |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 8 weeks
The ISI is composed of 7-items that asses for severity of sleep onset, sleep maintenance, early morning waking issues, sleep satisfaction, sleep interference (e.g., daytime fatigue), noticeability of sleep impairment, and sleep worry. Each item is measured on a five-point likert scale ranging from 0 indicating no severity to 4 indicating very severe. The ISI has been shown to be a valid, clinical questionnaire designed to gauge insomnia severity (Bastien, Vallières, \& Morin, 2001), is sensitive to treatment response (Morin, Belleville, Bélanger, \& Ivers, 2011), and has been agreed upon as essential for insomnia treatment efficacy studies (Buysse, Ancoli-Israel, Edinger, Lichstein, \& Morin, 2006). Additionally, the ISI has been used a previous randomized control trails (RCT) among college student to determine treatment efficacy (Taylor et al., 2014).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT Guide for Insomnia in people with Insomnia, run by Utah State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.