search
Back to results

An ACT Website for College Students With Insomnia

Primary Purpose

Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT Guide for Insomnia
Sponsored by
Utah State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, college student, university student, online

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Utah State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ACT Guide for Insomnia

Waitlist

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 16, 2023
Last Updated
October 20, 2023
Sponsor
Utah State University
search

1. Study Identification

Unique Protocol Identification Number
NCT06094751
Brief Title
An ACT Website for College Students With Insomnia
Official Title
Online ACT Guide for Sub-clinical and Clinical Insomnia Among College Students
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Utah State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, college student, university student, online

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACT Guide for Insomnia
Arm Type
Experimental
Arm Description
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
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
ACT Guide for Insomnia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael P Twohig, PhD
Phone
435-265-8933
Email
michael.twohig@usu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gabe San Miguel, M.S.
Phone
713 553 3731
Email
gabe.sanmiguel@usu.edu
Facility Information:
Facility Name
Utah State University
City
Logan
State/Province
Utah
ZIP/Postal Code
84321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabe San Miguel, M.S.
Email
gabe.sanmiguel@usu.edu

12. IPD Sharing Statement

Learn more about this trial

An ACT Website for College Students With Insomnia

We'll reach out to this number within 24 hrs