An ACT Website for College Students With Insomnia

Sponsor
Utah State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06094751
Collaborator
(none)
80
1
2
18.4
4.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ACT Guide for Insomnia
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Online ACT Guide for Sub-clinical and Clinical Insomnia Among College Students
Actual Study Start Date :
Oct 20, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: ACT Guide for Insomnia

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

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.

No Intervention: Waitlist

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).

Outcome Measures

Primary Outcome Measures

  1. Insomnia Severity Index (ISI) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Utah State University Logan Utah United States 84321

Sponsors and Collaborators

  • Utah State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Twohig, Ph.D., Professor, Utah State University
ClinicalTrials.gov Identifier:
NCT06094751
Other Study ID Numbers:
  • 13376
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael Twohig, Ph.D., Professor, Utah State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2023