Other Clinical Trial - Self-Help Video for Insomnia in College Students

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT01928173
Study type	Interventional
Source	University of Alabama, Tuscaloosa
Contact
Status	Terminated
Phase	N/A
Start date	February 2013
Completion date	November 2016

View Details

See also
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Completed	`NCT00044629` - Combined Behavioral/Pharmacological Therapy for Insomnia	Phase 2
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Completed	`NCT03852966` - Better Sleep in Psychiatric Care - ADHD Pilot Study	N/A
Terminated	`NCT00750919` - Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)	Phase 3
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.