Sleep Initiation and Maintenance DisordersNCT01928173
Self-Help Video for Insomnia in College Students
A study testing Abbreviated cognitive behavioral therapy and Sleep education/sleep hygiene in people with Sleep Initiation and Maintenance Disorders, run by University of Alabama, Tuscaloosa at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Abbreviated cognitive behavioral therapy and Sleep education/sleep hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must be a student at The University of Alabama
- Must be 18-24 years old
- Must have a complaint of insomnia
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama
Tuscaloosa, Alabama, 35487
About this study
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.
Read more
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.
- Being tested
- Abbreviated cognitive behavioral therapy, Sleep education/sleep hygiene
- Keywords
- Sleep Initiation and Maintenance Disorders, Cognitive Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbreviated cognitive behavioral therapyBehavioural
see arm description
Sleep education/sleep hygieneBehavioural
see arm description
| Study group | Role | What they receive |
|---|---|---|
| Abbreviated cognitive behavioral therapy | Active comparator | Arm 1 is a multi-component package including sleep hygiene, stimulus control, cognitive therapy, and passive relaxation. Receives: 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). Receives: Behavioral: Sleep education/sleep hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus Sleep Diary
Measured: Change in sleep diary variables at post-treatment (from baseline to 4 weeks after baseline)
Consensus Sleep Diary
Measured: Change in sleep diary variables at 1-month follow-up (post-treatment and 1-month follow-up)
Secondary outcomes (6)
Insomnia Severity Index
Measured: Change in score at post-treatment (from baseline to 4 weeks after baseline)
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.
Measured: 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
Measured: Change in sleep disturbance and daytime impairments at post-treatment (from baseline to 4 weeks after baseline)
Insomnia Severity Index
Measured: Change in score at 1-month follow-up (post-treatment and 1-month follow-up)
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.
Measured: Change in sleep knowledge at 1-month follow-up (post-treatment and 1-month follow-up)
Patient-Reported Outcomes Measurement Information System Sleep Disturbance and Sleep-Related Impairments Short Forms
Measured: Change in sleep disturbance and daytime impairments at 1-month follow-up (post-treatment and 1-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Lichstein, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928173
- Sponsor's protocol ID
- 13-OR-052-ME
- Status last verified
- Aug 2013
- First submitted
- 12 Jul 2013
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11438246Bixler 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.
PubMed 314756Bootzin, 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.
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.
PubMed 22294820Gustafson 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.
PubMed 1565709Kales 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.
PubMed 6496780Morin, C. M. (1993). Insomnia: Psychological assessment and management. New York-London: The Guilford Press.
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.
PubMed 3565914Rybarczyk 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.
PubMed 15984917Taylor 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.
PubMed 21491233
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Help Video for Insomnia in College Students
- ClinicalTrials.gov ID
- NCT01928173
- Acronym / sponsor ID
- 13-OR-052-ME
- Keywords
- Sleep Initiation and Maintenance Disorders, Cognitive Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participants
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abbreviated cognitive behavioral therapy | Active comparator | Behavioral: Abbreviated cognitive behavioral therapyArm 1 is a multi-component package including sleep hygiene, stimulus control, cognitive therapy, and passive relaxation. |
| Sleep education/sleep hygiene | Active comparator | Behavioral: Sleep education/sleep hygieneArm 2 consists of education about sleep and fatigue as well as sleep hygiene recommendations (e.g., avoiding nicotine and caffeine late in the day). |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must be a student at The University of Alabama
- Must be 18-24 years old
- Must have a complaint of insomnia
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbreviated cognitive behavioral therapysee arm description | Behavioural | Abbreviated cognitive behavioral therapy |
| Sleep education/sleep hygienesee arm description | Behavioural | Sleep education/sleep hygiene |
Primary outcome
Consensus Sleep Diary
Time frame: Change in sleep diary variables at post-treatment (from baseline to 4 weeks after baseline)
Consensus Sleep Diary
Time frame: Change in sleep diary variables at 1-month follow-up (post-treatment and 1-month follow-up)
6 secondary outcomes
Insomnia Severity Index
Time frame: Change in score at post-treatment (from baseline to 4 weeks after baseline)
Measure of Sleep Knowledge
Time frame: 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
Time frame: Change in sleep disturbance and daytime impairments at post-treatment (from baseline to 4 weeks after baseline)
Insomnia Severity Index
Time frame: Change in score at 1-month follow-up (post-treatment and 1-month follow-up)
Measure of Sleep Knowledge
Time frame: Change in sleep knowledge at 1-month follow-up (post-treatment and 1-month follow-up)
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)
Results and safety
The study was stopped early (reason given: Lack of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Background: PubMed 11438246Bastien 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.
- Background: PubMed 314756Bixler 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.
- BackgroundBootzin, 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: PubMed 22294820Carney 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.
- Background: PubMed 1565709Gustafson 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.
- Background: PubMed 6496780Kales 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.
- BackgroundMorin, C. M. (1993). Insomnia: Psychological assessment and management. New York-London: The Guilford Press.
- Background: PubMed 3565914Rosen 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.
- Background: PubMed 15984917Rybarczyk 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.
- Background: PubMed 21491233Taylor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Lichstein, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbreviated cognitive behavioral therapy and Sleep education/sleep hygiene in people with Sleep Initiation and Maintenance Disorders, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus Sleep Diary (time frame: Change in sleep diary variables at post-treatment (from baseline to 4 weeks after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01928173, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.