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Self-Help Video for Insomnia in College Students

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abbreviated cognitive behavioral therapy
Sleep education/sleep hygiene
Sponsored by
University of Alabama, Tuscaloosa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Sleep Initiation and Maintenance Disorders, Cognitive Therapy

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The University of Alabama

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Abbreviated cognitive behavioral therapy

Sleep education/sleep hygiene

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Consensus Sleep Diary
Consensus Sleep Diary

Secondary Outcome Measures

Insomnia Severity Index
Measure of Sleep Knowledge
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
Insomnia Severity Index
Measure of Sleep Knowledge
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

Full Information

First Posted
July 12, 2013
Last Updated
April 26, 2019
Sponsor
University of Alabama, Tuscaloosa
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1. Study Identification

Unique Protocol Identification Number
NCT01928173
Brief Title
Self-Help Video for Insomnia in College Students
Official Title
Self-Help Video for Insomnia in College Students
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of participants
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama, Tuscaloosa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
Sleep Initiation and Maintenance Disorders, Cognitive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abbreviated cognitive behavioral therapy
Arm Type
Active Comparator
Arm Description
Arm 1 is a multi-component package including sleep hygiene, stimulus control, cognitive therapy, and passive relaxation.
Arm Title
Sleep education/sleep hygiene
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Abbreviated cognitive behavioral therapy
Intervention Description
see arm description
Intervention Type
Behavioral
Intervention Name(s)
Sleep education/sleep hygiene
Intervention Description
see arm description
Primary Outcome Measure Information:
Title
Consensus Sleep Diary
Time Frame
Change in sleep diary variables at post-treatment (from baseline to 4 weeks after baseline)
Title
Consensus Sleep Diary
Time Frame
Change in sleep diary variables at 1-month follow-up (post-treatment and 1-month follow-up)
Secondary Outcome Measure Information:
Title
Insomnia Severity Index
Time Frame
Change in score at post-treatment (from baseline to 4 weeks after baseline)
Title
Measure of Sleep Knowledge
Description
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.
Time Frame
Change in number of correct responses at post-treatment (from baseline to 4 weeks after baseline)
Title
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)
Title
Insomnia Severity Index
Time Frame
Change in score at 1-month follow-up (post-treatment and 1-month follow-up)
Title
Measure of Sleep Knowledge
Description
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.
Time Frame
Change in sleep knowledge at 1-month follow-up (post-treatment and 1-month follow-up)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Lichstein, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11438246
Citation
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.
Results Reference
background
PubMed Identifier
314756
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
22294820
Citation
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.
Results Reference
background
PubMed Identifier
1565709
Citation
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.
Results Reference
background
PubMed Identifier
6496780
Citation
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.
Results Reference
background
Citation
Morin, C. M. (1993). Insomnia: Psychological assessment and management. New York-London: The Guilford Press.
Results Reference
background
PubMed Identifier
3565914
Citation
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.
Results Reference
background
PubMed Identifier
15984917
Citation
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.
Results Reference
background
PubMed Identifier
21491233
Citation
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.
Results Reference
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Self-Help Video for Insomnia in College Students

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