Self-Help Video for Insomnia in College Students

April 26, 2019 updated by: University of Alabama, Tuscaloosa

The purpose of this study is to test the effectiveness of a 1-session abbreviated cognitive-behavior therapy for insomnia among college students. The investigators will examine the following hypotheses in the present study: 1) Viewing the treatment video will produce an increment in sleep knowledge relative to baseline and minimum treatment control; and 2) Viewing the treatment video will result in improved sleep relative to baseline and minimum treatment control.

Students who self-identify as having insomnia will be recruited from the University of Alabama's Psychology subject pool. Students who enroll in the study will receive a link to the demographic and screening questionnaire. Individuals who have a history of other sleep disorders or who currently present with symptoms strongly suggestive of sleep disorders, such as obstructive sleep apnea or narcolepsy will be excluded. Individuals who are shift-workers and those with a history of severe mental illness will also be excluded.

Participants who meet criteria for this study will then be directed to complete a measure of sleep knowledge. Once they have completed the measure of sleep knowledge, they will be directed to complete the Consensus Sleep Diary (CSD) for 14 days as soon as possible after awakening in the morning. During the second week of completing the CSD, participants will be directed to complete the Insomnia Severity Index and the Patient-Reported Outcomes Measurement Information System Sleep Disturbance and Sleep-Related Impairments Short Forms on the last day they complete a CSD.

Participants will be randomized to a treatment group or a minimum treatment control group upon completion of these baseline measures. Those in the treatment group will be emailed the following components of the insomnia treatment: a link to the treatment video, an mp3 file with a relaxation recording, and a pdf file of a brochure reviewing the information presented in the treatment video. Participants will be asked to view the treatment video and begin practicing the relaxation technique presented in the mp3 file as soon as possible. Participants in the minimum treatment control group will receive a link to a sleep education video.

Two weeks after participants have viewed the videos, they will be asked to complete post-treatment measures in the same sequence as they did at baseline. One month after the post-treatment measures have been completed, both groups will be asked to complete the same measures again for follow-up.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35487
        • The University of Alabama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be a student at The University of Alabama
  • Must be 18-24 years old
  • Must have a complaint of insomnia

Exclusion Criteria:

  • history of sleep disorder other than insomnia
  • symptoms strongly suggestive of sleep disorders other than insomnia
  • shift-work
  • history of severe mental illness (e.g., psychotic disorders, bipolar disorder, severe depression, or personality disorders)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Abbreviated cognitive behavioral therapy
Arm 1 is a multi-component package including sleep hygiene, stimulus control, cognitive therapy, and passive relaxation.
Behavioral: Abbreviated cognitive behavioral therapy
see arm description
ACTIVE_COMPARATOR: Sleep education/sleep hygiene
Arm 2 consists of education about sleep and fatigue as well as sleep hygiene recommendations (e.g., avoiding nicotine and caffeine late in the day).
Behavioral: Sleep education/sleep hygiene
see arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Consensus Sleep Diary
Time Frame: Change in sleep diary variables at post-treatment (from baseline to 4 weeks after baseline)
Change in sleep diary variables at post-treatment (from baseline to 4 weeks after baseline)
Consensus Sleep Diary
Time Frame: Change in sleep diary variables at 1-month follow-up (post-treatment and 1-month follow-up)
Change in sleep diary variables at 1-month follow-up (post-treatment and 1-month follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index
Time Frame: Change in score at post-treatment (from baseline to 4 weeks after baseline)
Change in score at post-treatment (from baseline to 4 weeks after baseline)
Measure of Sleep Knowledge
Time Frame: Change in number of correct responses at post-treatment (from baseline to 4 weeks after baseline)
An 8-item true/false questionnaire that assesses participants' knowledge about sleep and cognitive behavioral therapy for insomnia treatment (stimulus control, sleep hygiene, relaxation, and cognitive therapy). A participant's score on this measure is the number of correct responses.
Change in number of correct responses at post-treatment (from baseline to 4 weeks after baseline)
Patient-Reported Outcomes Measurement Information System Sleep Disturbance and Sleep-Related Impairments Short Forms
Time Frame: Change in sleep disturbance and daytime impairments at post-treatment (from baseline to 4 weeks after baseline)
Change in sleep disturbance and daytime impairments at post-treatment (from baseline to 4 weeks after baseline)
Insomnia Severity Index
Time Frame: Change in score at 1-month follow-up (post-treatment and 1-month follow-up)
Change in score at 1-month follow-up (post-treatment and 1-month follow-up)
Measure of Sleep Knowledge
Time Frame: Change in sleep knowledge at 1-month follow-up (post-treatment and 1-month follow-up)
An 8-item true/false questionnaire that assesses participants' knowledge about sleep and cognitive behavioral therapy for insomnia treatment (stimulus control, sleep hygiene, relaxation, and cognitive therapy). A participant's score on this measure is the number of correct responses.
Change in sleep knowledge at 1-month follow-up (post-treatment and 1-month follow-up)
Patient-Reported Outcomes Measurement Information System Sleep Disturbance and Sleep-Related Impairments Short Forms
Time Frame: Change in sleep disturbance and daytime impairments at 1-month follow-up (post-treatment and 1-month follow-up)
Change in sleep disturbance and daytime impairments at 1-month follow-up (post-treatment and 1-month follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama, Tuscaloosa

Investigators

  • Principal Investigator: Kenneth Lichstein, PhD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

August 20, 2013

First Posted (ESTIMATE)

August 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-OR-052-ME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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