Clinical trial NCT01928173: Self-Help Video for Insomnia in College Students
Official title: Self-Help Video for Insomnia in College Students
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Sleep Initiation and Maintenance Disorders
Cognitive Therapy
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Consensus Sleep Diary
timeFrame: Change in sleep diary variables at post-treatment (from baseline to 4 weeks after baseline)
measure: Consensus Sleep Diary
timeFrame: Change in sleep diary variables at 1-month follow-up (post-treatment and 1-month follow-up)
Secondary outcomes:
measure: Insomnia Severity Index
timeFrame: Change in score at post-treatment (from baseline to 4 weeks after baseline)
measure: Measure of Sleep Knowledge
timeFrame: Change in number of correct responses at post-treatment (from baseline to 4 weeks after baseline)
measure: Patient-Reported Outcomes Measurement Information System Sleep Disturbance and Sleep-Related Impairments Short Forms
timeFrame: Change in sleep disturbance and daytime impairments at post-treatment (from baseline to 4 weeks after baseline)
measure: Insomnia Severity Index
timeFrame: Change in score at 1-month follow-up (post-treatment and 1-month follow-up)
measure: Measure of Sleep Knowledge
timeFrame: Change in sleep knowledge at 1-month follow-up (post-treatment and 1-month follow-up)
measure: Patient-Reported Outcomes Measurement Information System Sleep Disturbance and Sleep-Related Impairments Short Forms
timeFrame: Change in sleep disturbance and daytime impairments at 1-month follow-up (post-treatment and 1-month follow-up)
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: The University of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Kenneth Lichstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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