Self-Help Video for Insomnia in College Students

This study has suspended participant recruitment.
(Summer vacation)
Sponsor:
Information provided by (Responsible Party):
University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier:
NCT01928173
First received: July 12, 2013
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Sleep Initiation and Maintenance Disorders
Behavioral: Abbreviated cognitive behavioral therapy
Behavioral: Sleep education/sleep hygiene

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Self-Help Video for Insomnia in College Students

Resource links provided by NLM:


Further study details as provided by University of Alabama, Tuscaloosa:

Primary Outcome Measures:
  • Consensus Sleep Diary [ Time Frame: Change in sleep diary variables at post-treatment (from baseline to 4 weeks after baseline) ] [ Designated as safety issue: No ]
  • Consensus Sleep Diary [ Time Frame: Change in sleep diary variables at 1-month follow-up (post-treatment and 1-month follow-up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insomnia Severity Index [ Time Frame: Change in score at post-treatment (from baseline to 4 weeks after baseline) ] [ Designated as safety issue: No ]
  • Measure of Sleep Knowledge [ Time Frame: Change in number of correct responses at post-treatment (from baseline to 4 weeks after baseline) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
  • Insomnia Severity Index [ Time Frame: Change in score at 1-month follow-up (post-treatment and 1-month follow-up) ] [ Designated as safety issue: No ]
  • Measure of Sleep Knowledge [ Time Frame: Change in sleep knowledge at 1-month follow-up (post-treatment and 1-month follow-up) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01928173

Locations
United States, Alabama
The University of Alabama
Tuscaloosa, Alabama, United States, 35487
Sponsors and Collaborators
University of Alabama, Tuscaloosa
Investigators
Principal Investigator: Kenneth Lichstein, PhD University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier: NCT01928173     History of Changes
Other Study ID Numbers: 13-OR-052-ME
Study First Received: July 12, 2013
Last Updated: August 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama, Tuscaloosa:
Sleep Initiation and Maintenance Disorders
Cognitive Therapy

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014