An ACT Website for College Students With Insomnia

Insomnia Clinical Trial

Official title:

Online ACT Guide for Sub-clinical and Clinical Insomnia Among College Students

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094751
• Other study ID #: 13376
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: Utah State University
• Contact: Michael P Twohig, PhD
• Phone: 435-265-8933
• Email: michael.twohig[@]usu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years or older

2. enrolled in a 2- or 4-year college (includes graduate students)

3. fluent in English

4. have access to the internet

5. meets diagnosis for at least acute insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5

6. searching/wanting in treatment

7. currently residing in the US

Exclusion Criteria:

1. diagnosed with another sleep disorder that is not insomnia

2. currently attending therapy for an emotional disorder (anxiety or depression) or insomnia

3. prescribed medications to treat insomnia or another sleep-inducing medication

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• ACT Guide for Insomnia
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.

Locations

Country	Name	City	State
United States	Utah State University	Logan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Utah State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	8 weeks