Post-Traumatic Stress DisorderNCT00881647
Treating People With Post-Traumatic Stress Disorder With Cognitive Behavioral Therapy for Insomnia
A study testing Cognitive Behavioral Treatment for Insomnia (CBT-I) in people with Post-Traumatic Stress Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study will test the effectiveness of cognitive behavioral therapy for insomnia in treating sleep disturbances in people with post-traumatic stress disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Cognitive Behavioral Treatment for Insomnia (CBT-I)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic PTSD for at least 3 months
- Currently on first line treatment for PTSD, defined as selective serotonin reuptake inhibitor (SSRI) therapy, for at least 6 months
- Persistent residual insomnia
Who cannot join
- Conditions or substances that may be associated with comorbid insomnia independent of PTSD
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, San Francisco
San Francisco, California, 94121
About this study
Official title: Cognitive Behavioral Treatment of Insomnia in Posttraumatic Stress Disorder
This study will test the effectiveness of cognitive behavioral therapy for insomnia in treating sleep disturbances in people with post-traumatic stress disorder.
Read the detailed description
Cognitive behavioral therapy to treat insomnia (CBT-I) was developed for people with primary insomnia but has been successfully used to treat insomnia in people with other disorders. Insomnia is the most commonly reported complaint of patients receiving treatment for post-traumatic stress disorder (PTSD). Medications are not effective in treating insomnia in people with PTSD, and behavioral treatments, like CBT-I, have not yet been proven effective in these cases. This study will test the effectiveness of CBT-I in alleviating insomnia in people with PTSD.
Participation in this study will last 10 months. At study entry, participants will complete a series of eligibility assessments, including a clinical interview, a medical screening, a urine screening for drugs of abuse, a blood test, and a pregnancy test. Then, over 1 week, participants will complete baseline assessments of sleep behaviors. The assessments will include the following: filling out a set of questionnaires about health, mood, sleeping patterns, possible life trauma, and PTSD; filling out a sleep diary every morning to record time slept, times woken up, nightmares, and quality of sleep; wearing a wristwatch-like device, called an Actigraph, that records activity level during wakefulness and sleep; completing a 5-minute psychomotor vigilance task twice a day on a personal digital assistant (PDA); wearing a sensor connected to the finger that detects sleep apnea, called an Oximeter, 1 night while sleeping; and, during the last 2 nights of sleep assessment, having a sleep recorder connected to one's head to measure different stages of sleep.
After the week of sleep assessments, participants will be randomly assigned to one of two groups: the CBT-I group or the waitlist group. Participants in the CBT-I group will complete eight weekly therapy sessions targeted at improving quality of sleep and resolving problems with falling and staying asleep. Participants in the waitlist group will not be offered CBT-I treatment until after 8 weeks. During these 8 weeks, all participants will continue to keep a sleep diary, continue wearing the Actigraph, and, in the fourth week, be asked to fill out a questionnaire booklet with similar questions to those completed in the eligibility screening. After 8 weeks, participants will repeat all the sleep assessments performed at baseline. They will also undergo a clinical interview to assess the severity of PTSD symptoms and sleep problems. After the second set of sleep assessments, the waitlist group will be offered CBT-I, and the CBT-I group will complete 6- and 12-month follow-up assessments. These follow-up assessments will involve repeating both the sleep assessments and the clinical interview performed after the 8-week intervention.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Cognitive Behavioral Treatment for Insomnia (CBT-I)
- Keywords
- PTSD, Insomnia Disorder, Insomnia, CBT
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Treatment for Insomnia (CBT-I)Other
CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive an 8-week course of cognitive behavioral therapy for insomnia. Receives: Other: Cognitive Behavioral Treatment for Insomnia (CBT-I) |
| 2 | No intervention | Participants will be placed on a waitlist for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Latency (SL)
In a self-report sleep diary, participants were asked to report the length of time it takes from lying down for the night until sleep onset. This outcome consists of the posttreatment (CBT-I) or post-waitlist diary entry; In other words, each of the values below was measured at 8 weeks.
Measured: After 8 weeks of study participation
Minutes of Wake After Sleep Onset (WASO)
WASO was the sum of wake time during sleep as recorded in a self-report sleep diary, and as measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]). This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.
Measured: After 8 weeks of study participation
Sleep Efficiency (SE)
SE, as determined by polysomnography (PSG) and by self-reported sleep diary, was the total sleep time (TST) divided by the time in bed, multiplied by 100. This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.
Measured: After 8 weeks of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startNov 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Thomas C. Neylan, MD, Principal investigator, University of California, San Francisco/VA Medical Center, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881647
- Sponsor's protocol ID
- R34MH077667
- Other IDs
- R34MH077667, DATR AD-TS
- Status last verified
- Feb 2014
- First submitted
- 14 Apr 2009
- Last updated
- 17 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kanady JC, Talbot LS, Maguen S, Straus LD, Richards A, Ruoff L, Metzler TJ, Neylan TC. Cognitive Behavioral Therapy for Insomnia Reduces Fear of Sleep in Individuals With Posttraumatic Stress Disorder. J Clin Sleep Med. 2018 Jul 15;14(7):1193-1203. doi: 10.5664/jcsm.7224.
PubMed 29991428Talbot LS, Maguen S, Metzler TJ, Schmitz M, McCaslin SE, Richards A, Perlis ML, Posner DA, Weiss B, Ruoff L, Varbel J, Neylan TC. Cognitive behavioral therapy for insomnia in posttraumatic stress disorder: a randomized controlled trial. Sleep. 2014 Feb 1;37(2):327-41. doi: 10.5665/sleep.3408.
PubMed 24497661
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Treatment of Insomnia in Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00881647
- Acronym / sponsor ID
- R34MH077667
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, Insomnia Disorder, Insomnia, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Posted 21 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the effectiveness of cognitive behavioral therapy for insomnia in treating sleep disturbances in people with post-traumatic stress disorder.
Detailed description
Cognitive behavioral therapy to treat insomnia (CBT-I) was developed for people with primary insomnia but has been successfully used to treat insomnia in people with other disorders. Insomnia is the most commonly reported complaint of patients receiving treatment for post-traumatic stress disorder (PTSD). Medications are not effective in treating insomnia in people with PTSD, and behavioral treatments, like CBT-I, have not yet been proven effective in these cases. This study will test the effectiveness of CBT-I in alleviating insomnia in people with PTSD.
Participation in this study will last 10 months. At study entry, participants will complete a series of eligibility assessments, including a clinical interview, a medical screening, a urine screening for drugs of abuse, a blood test, and a pregnancy test. Then, over 1 week, participants will complete baseline assessments of sleep behaviors. The assessments will include the following: filling out a set of questionnaires about health, mood, sleeping patterns, possible life trauma, and PTSD; filling out a sleep diary every morning to record time slept, times woken up, nightmares, and quality of sleep; wearing a wristwatch-like device, called an Actigraph, that records activity level during wakefulness and sleep; completing a 5-minute psychomotor vigilance task twice a day on a personal digital assistant (PDA); wearing a sensor connected to the finger that detects sleep apnea, called an Oximeter, 1 night while sleeping; and, during the last 2 nights of sleep assessment, having a sleep recorder connected to one's head to measure different stages of sleep.
After the week of sleep assessments, participants will be randomly assigned to one of two groups: the CBT-I group or the waitlist group. Participants in the CBT-I group will complete eight weekly therapy sessions targeted at improving quality of sleep and resolving problems with falling and staying asleep. Participants in the waitlist group will not be offered CBT-I treatment until after 8 weeks. During these 8 weeks, all participants will continue to keep a sleep diary, continue wearing the Actigraph, and, in the fourth week, be asked to fill out a questionnaire booklet with similar questions to those completed in the eligibility screening. After 8 weeks, participants will repeat all the sleep assessments performed at baseline. They will also undergo a clinical interview to assess the severity of PTSD symptoms and sleep problems. After the second set of sleep assessments, the waitlist group will be offered CBT-I, and the CBT-I group will complete 6- and 12-month follow-up assessments. These follow-up assessments will involve repeating both the sleep assessments and the clinical interview performed after the 8-week intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Cognitive Behavioral Treatment for Insomnia (CBT-I)Participants will receive an 8-week course of cognitive behavioral therapy for insomnia. |
| 2 | No intervention | –Participants will be placed on a waitlist for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic PTSD for at least 3 months
- Currently on first line treatment for PTSD, defined as selective serotonin reuptake inhibitor (SSRI) therapy, for at least 6 months
- Persistent residual insomnia
Key exclusion criteria (1 listed)
- Conditions or substances that may be associated with comorbid insomnia independent of PTSD
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 |
|---|---|---|
| Cognitive Behavioral Treatment for Insomnia (CBT-I)CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep | Other | 1 |
Primary outcome
Sleep Latency (SL)
Time frame: After 8 weeks of study participation
In a self-report sleep diary, participants were asked to report the length of time it takes from lying down for the night until sleep onset. This outcome consists of the posttreatment (CBT-I) or post-waitlist diary entry; In other words, each of the values below was measured at 8 weeks.
Minutes of Wake After Sleep Onset (WASO)
Time frame: After 8 weeks of study participation
WASO was the sum of wake time during sleep as recorded in a self-report sleep diary, and as measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]). This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.
Sleep Efficiency (SE)
Time frame: After 8 weeks of study participation
SE, as determined by polysomnography (PSG) and by self-reported sleep diary, was the total sleep time (TST) divided by the time in bed, multiplied by 100. This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29991428Kanady JC, Talbot LS, Maguen S, Straus LD, Richards A, Ruoff L, Metzler TJ, Neylan TC. Cognitive Behavioral Therapy for Insomnia Reduces Fear of Sleep in Individuals With Posttraumatic Stress Disorder. J Clin Sleep Med. 2018 Jul 15;14(7):1193-1203. doi: 10.5664/jcsm.7224.
- Derived from this study: PubMed 24497661Talbot LS, Maguen S, Metzler TJ, Schmitz M, McCaslin SE, Richards A, Perlis ML, Posner DA, Weiss B, Ruoff L, Varbel J, Neylan TC. Cognitive behavioral therapy for insomnia in posttraumatic stress disorder: a randomized controlled trial. Sleep. 2014 Feb 1;37(2):327-41. doi: 10.5665/sleep.3408.
- More information about the Stress \& Health Research ProgramLink provided by the sponsor.
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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.
Thomas C. Neylan, MD principal investigator
University of California, San Francisco/VA Medical Center, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Treatment for Insomnia (CBT-I) in people with Post-Traumatic Stress Disorder, run by University of California, San Francisco 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 1 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: finished, as of the sponsor's last update on 17 Mar 2014. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sleep Latency (SL) (time frame: After 8 weeks of study participation). The study lists 3 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 NCT00881647, which also lists 2 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 17 Mar 2014.