NCT06094751

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

October 16, 2023

Last Update Submit

October 20, 2023

Conditions

Keywords

Insomniacollege studentuniversity studentonline

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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).

Interventions

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.

ACT Guide for Insomnia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utah State University

Logan, Utah, 84321, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Michael P Twohig, PhD

CONTACT

Gabe San Miguel, M.S.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 23, 2023

Study Start

October 20, 2023

Primary Completion

December 1, 2024

Study Completion

May 1, 2025

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations