Self-Help Video for Insomnia in College Students

NCT01928173 | Terminated

• 1 other identifier: 13-OR-052-ME
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Sleep Initiation and Maintenance Disorders; Cognitive Therapy

Outcome Measures

Primary Outcomes (2)

• Consensus Sleep Diary

  Change in sleep diary variables at post-treatment (from baseline to 4 weeks after baseline)

• Consensus Sleep Diary

  Change in sleep diary variables at 1-month follow-up (post-treatment and 1-month follow-up)

Secondary Outcomes (6)

• Insomnia Severity Index

  Change in score at post-treatment (from baseline to 4 weeks after baseline)

• Measure of Sleep Knowledge

  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

  Change in sleep disturbance and daytime impairments at post-treatment (from baseline to 4 weeks after baseline)

• Insomnia Severity Index

  Change in score at 1-month follow-up (post-treatment and 1-month follow-up)

• Measure of Sleep Knowledge

  Change in sleep knowledge at 1-month follow-up (post-treatment and 1-month follow-up)

Study Arms (2)

Abbreviated cognitive behavioral therapy

ACTIVE COMPARATOR

Arm 1 is a multi-component package including sleep hygiene, stimulus control, cognitive therapy, and passive relaxation.

Behavioral: Abbreviated cognitive behavioral therapy

Sleep education/sleep hygiene

ACTIVE COMPARATOR

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

Interventions

Abbreviated cognitive behavioral therapy BEHAVIORAL

see arm description

Abbreviated cognitive behavioral therapy

Sleep education/sleep hygiene BEHAVIORAL

see arm description

Sleep education/sleep hygiene

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead

Study Sites (1)

The University of Alabama

Tuscaloosa, Alabama, 35487, United States

Location

Related Publications (10)

• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

  PMID: 11438246 BACKGROUND

• Bixler EO, Kales A, Soldatos CR, Kales JD, Healey S. Prevalence of sleep disorders in the Los Angeles metropolitan area. Am J Psychiatry. 1979 Oct;136(10):1257-62. doi: 10.1176/ajp.136.10.1257.

  PMID: 314756 BACKGROUND

• Bootzin, R.R., & Epstein, D.R. (2000). Stimulus control instructions. In K.L. Lichstein & C.M. Morin (Eds.), Treatment of late-life insomnia (pp 167-184). Thousand Oaks, CA: Sage.

  BACKGROUND

• Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.

  PMID: 22294820 BACKGROUND

• Gustafson R. Treating insomnia with a self-administered muscle relaxation training program: a follow-up. Psychol Rep. 1992 Feb;70(1):124-6. doi: 10.2466/pr0.1992.70.1.124.

  PMID: 1565709 BACKGROUND

• Kales JD, Kales A, Bixler EO, Soldatos CR, Cadieux RJ, Kashurba GJ, Vela-Bueno A. Biopsychobehavioral correlates of insomnia, V: Clinical characteristics and behavioral correlates. Am J Psychiatry. 1984 Nov;141(11):1371-6. doi: 10.1176/ajp.141.11.1371.

  PMID: 6496780 BACKGROUND

• Morin, C. M. (1993). Insomnia: Psychological assessment and management. New York-London: The Guilford Press.

  BACKGROUND

• Rosen GM. Self-help treatment books and the commercialization of psychotherapy. Am Psychol. 1987 Jan;42(1):46-51. doi: 10.1037//0003-066x.42.1.46. No abstract available.

  PMID: 3565914 BACKGROUND

• Rybarczyk B, Lopez M, Schelble K, Stepanski E. Home-based video CBT for comorbid geriatric insomnia: a pilot study using secondary data analyses. Behav Sleep Med. 2005;3(3):158-75. doi: 10.1207/s15402010bsm0303_4.

  PMID: 15984917 BACKGROUND

• Taylor DJ, Gardner CE, Bramoweth AD, Williams JM, Roane BM, Grieser EA, Tatum JI. Insomnia and mental health in college students. Behav Sleep Med. 2011;9(2):107-16. doi: 10.1080/15402002.2011.557992.

  PMID: 21491233 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Kenneth Lichstein, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: August 23, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 30, 2019

Record last verified: 2013-08

Locations

US (1)