InsomniaPhase 3NCT01549899
Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia
A Phase 3 study testing In-person Cognitive Behavioral Therapy of Insomnia and Internet Cognitive Behavioral Therapy of Insomnia in people with Insomnia, run by Daniel J. Taylor, Ph.D. at 1 site in United States.
Trial summary
The objective of this study is to directly compare 6 sessions of in-person and Internet administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a Minimal Contact control (MC), within an active duty military population to determine the comparative benefits of these interventions on improvement in sleep as well… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- In-person Cognitive Behavioral Therapy of Insomnia and Internet Cognitive Behavioral Therapy of Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic Insomnia as defined by Research Diagnostic Criteria (RDC) criteria41 Complaint of > 3 months (chronic insomnia) of disturbed sleep >3 nights/week (severe insomnia) as defined by at least one of the following as assessed by sleep diaries: Sleep Onset Latency of >30 min (initial insomnia) and/or Wake After Sleep-Onset of >30 min (middle insomnia) and/or Early Morning Awakening of >30 min before the desired wakeup time (late insomnia) and Sleep Efficiency < 85%
- Active Duty military member stationed at Fort Hood as assessed by self-report.
- History of having deployed in support of OIF or OEF as assessed by self-report. • Stable on psychotropic and/or hypnotic medications for at least one month as assessed by self-report and review of medical record.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544
About this study
The objective of this study is to directly compare 6 sessions of in-person and Internet administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a Minimal Contact control (MC), within an active duty military population to determine the comparative benefits of these interventions on improvement in sleep as well as domains strongly related to insomnia such as depression, substance abuse, and PTSD symptoms. A total of 189 military personnel with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions (over 6 weeks) of CBTi (n=77), ICBTi (n=35), or a MC control (n=77) condition. The investigators will compare these three groups on subjective and objective measures of sleep. The CBTi and MC control groups will be compared on other variables of interest (e.g., depression, substance abuse, and PTSD symptoms) and predictors of outcomes.
- Conditions
- Insomnia
- Being tested
- In-person Cognitive Behavioral Therapy of Insomnia, Internet Cognitive Behavioral Therapy of Insomnia
- Keywords
- Insomnia, Cognitive, Behavioral, Therapy, Internet, Depression, Substance Use, Post-Tramatic Stress Disorder
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Behavior, Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person Cognitive Behavioral Therapy of InsomniaBehavioural
In-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education \& hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy).
Internet Cognitive Behavioral Therapy of InsomniaBehavioural
The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its automated, online format. Each of the six ICBTi sessions was divided into lessons covering different aspects of each of the components. The lessons were presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components were included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits.
| Study group | Role | What they receive |
|---|---|---|
| In-person CBT of Insomnia | Active comparator | CBTi consisted of 6 weekly 60-minute sessions and included identical informational material. The treatments contained the following efficacious and commonly used modules of cognitive behavioral treatments for insomnia: Stimulus Control, Sleep Restriction, Sleep Hygiene, Relaxation Training, Cognitive Restructuring. Receives: Behavioral: In-person Cognitive Behavioral Therapy of Insomnia |
| Internet CBT of Insomnia | Active comparator | The I-CBTi protocol was developed by the National Center for Telehealth and Technology with the first author (DJT) serving as the subject matter expert, and administered on the afterdeployment.org website. The information and instructions for I-CBTi were identical to in-person CBTi; however, their mode of delivery in I-CBTi is considerably different due to the constraints of its automated, online format. The lessons were presented as audio recordings accompanied by visual graphics and animations and several lessons, had interactive components such as games, quizzes, and prompts for participants to schedule healthy sleep habits. Receives: Behavioral: Internet Cognitive Behavioral Therapy of Insomnia |
| Minimal Contact | No intervention | Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Diary Sleep Efficiency
Provides daily self-reports of bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine self-reported sleep efficiency (i.e., total sleep time/time in bed X 100). Other variable to be extracted will include total sleep time and total wake time.
Measured: Change from Baseline to Post-Treatment and 6 month follow-up
Secondary outcomes (10)
Beck Depression Inventory II
Measure of self-reported depression symptoms.
Measured: Change from Baseline to Post-Treatment and 6 month follow-up
Substance Use
Self-reported use of sleep medications, caffeine, and nicotine obtained during the interview and on sleep diaries.
Measured: Change from Baseline to Post-Treatment and 6 month follow-up
Actigraphy
A wrist worn accelerometer that measures activity level and then uses validated algorithms to determine objectively daily bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine objective sleep efficiency (i.e., total sleep time/time in bed X 100). Other variable to be extracted will include total sleep time and total wake time.
Measured: Change from Baseline to Post-Treatment and 6 month follow-up
PTSD Check List-Military
Measures self-reported Post-Traumatic Stress Disorders symptoms in military personnel.
Measured: Change from Baseline to Post-Treatment and 6 month follow-up
Beck Anxiety Inventory
Self-report measure of anxiety symptoms
Measured: Change from Baseline to Post-Treatment and 6 month follow-up
Insomnia Severity Index
Self-report insomnia symptoms.
Measured: Change from Baseline to Post-Treatment and 6 month follow-up
Epworth Sleepiness Scale
Self-report daytime sleepiness.
Measured: Change from Baseline to Post-Treatment and 6 month follow-up
Dysfunctional Beliefs and Attitudes About Sleep Scale
Self-reported beliefs and attitudes about sleep.
Measured: Change from Baseline to Post-Treatment and 6 month follow-up
Multidimensional Fatigue Inventory
Self-reported fatigue symptoms across multiple dimensions.
Measured: Change from Baseline to Post-Treatment and 6 month follow-up
Veterans Rand 12-Item Health Survey
Self-reported quality of life and health.
Measured: Change from Baseline to Post-Treatment and 6 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 posted9 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2015
- Study completionSep 2015
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 (8)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel J. Taylor, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, C.R.Darnall Army Medical Center, The University of Texas Health Science Center at San Antonio
- Responsible party
- Sponsor-investigator, Daniel J. Taylor, Ph.D., University of North Texas, Denton, TX
- Investigators
- Daniel J Taylor, Ph.D., Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549899
- Sponsor's protocol ID
- W81XWH-10-1-0828
- Other IDs
- PT090525
- Status last verified
- Apr 2025
- First submitted
- 4 Feb 2012
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Taylor DJ, Wilkerson AK, Pruiksma KE, Williams JM, Ruggero CJ, Hale W, Mintz J, Organek KM, Nicholson KL, Litz BT, Young-McCaughan S, Dondanville KA, Borah EV, Brundige A, Peterson AL; STRONG STAR Consortium. Reliability of the Structured Clinical Interview for DSM-5 Sleep Disorders Module. J Clin Sleep Med. 2018 Mar 15;14(3):459-464. doi: 10.5664/jcsm.7000.
PubMed 29458705Peterson AL, Young-McCaughan S, Roache JD, Mintz J, Litz BT, Williamson DE, Resick PA, Foa EB, McGeary DD, Dondanville KA, Taylor DJ, Wachen JS, Fox PT, Bryan CJ, McLean CP, Pruiksma KE, Yarvis JS, Niles BL, Abdallah CG, Averill LA, Back SE, Baker MT, Blount TH, Borah AM, Borah EV, Brock MS, Brown LA, Burg MM, Cigrang JA, DeBeer BB, DeVoe ER, Fina BA, Flanagan JC, Fredman SJ, Gardner CL, Gatchel RR, Goodie JL, Gueorguieva R, Higgs JB, Jacoby VM, Kelly KM, Krystal JH, Lapiz-Bluhm MD, Lopez-Roca AL, Marx BP, Maurer DM, McDevitt-Murphy ME, McGeary CA, Meyer EC, Miles SR, Monson CM, Morilak DA, Moring JC, Mysliwiec V, Nicholson KL, Rauch SAM, Riggs DS, Rosen CS, Rudd MD, Schobitz RP, Schrader CC, Shinn AM, Shiroma PR, Sloan DM, Stern SL, Strong R, Vannoy SD, Young KA, Keane TM; STRONG STAR Consortium and the Consortium to Alleviate PTSD. STRONG STAR and the Consortium to Alleviate PTSD: Shaping the future of combat PTSD and related conditions in military and veteran populations. Contemp Clin Trials. 2021 Nov;110:106583. doi: 10.1016/j.cct.2021.106583. Epub 2021 Sep 29.
PubMed 34600107Brown LA, Zang Y, Benhamou K, Taylor DJ, Bryan CJ, Yarvis JS, Dondanville KA, Litz BT, Mintz J, Roache JD, Pruiksma KE, Fina BA, Young-McCaughan S, Peterson AL, Foa EB; STRONG STAR Consortium. Mediation of suicide ideation in prolonged exposure therapy for posttraumatic stress disorder. Behav Res Ther. 2019 Aug;119:103409. doi: 10.1016/j.brat.2019.103409. Epub 2019 May 23.
PubMed 31176888Brown LA, Bryan CJ, Butner JE, Tabares JV, Young-McCaughan S, Hale WJ, Fina BA, Foa EB, Resick PA, Taylor DJ, Coon H, Williamson DE, Dondanville KA, Borah EV, McLean CP, Wachen JS, Pruiksma KE, Hernandez AM, Litz BT, Mintz J, Yarvis JS, Borah AM, Nicholson KL, Maurer DM, Kelly KM, Peterson AL; STRONG STAR Consortium. Identifying suicidal subtypes and dynamic indicators of increasing and decreasing suicide risk in active duty military personnel: Study protocol. Contemp Clin Trials Commun. 2021 Feb 16;21:100752. doi: 10.1016/j.conctc.2021.100752. eCollection 2021 Mar.
PubMed 33748530Ben Barnes J, Presseau C, Jordan AH, Kline NK, Young-McCaughan S, Keane TM, Peterson AL, Litz BT; the Consortium to Alleviate PTSD. Common Data Elements in the Assessment of Military-Related PTSD Research Applied in the Consortium to Alleviate PTSD. Mil Med. 2019 May 1;184(5-6):e218-e226. doi: 10.1093/milmed/usy226.
PubMed 30252077Taylor DJ, Peterson AL, Pruiksma KE, Hale WJ, Young-McCaughan S, Wilkerson A, Nicholson K, Litz BT, Dondanville KA, Roache JD, Borah EV, Brundige A, Mintz J; STRONG STAR Consortium. Impact of cognitive behavioral therapy for insomnia disorder on sleep and comorbid symptoms in military personnel: a randomized clinical trial. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy069.
PubMed 29618098Taylor DJ, Peterson AL, Pruiksma KE, Young-McCaughan S, Nicholson K, Mintz J; STRONG STAR Consortium. Internet and In-Person Cognitive Behavioral Therapy for Insomnia in Military Personnel: A Randomized Clinical Trial. Sleep. 2017 Jun 1;40(6). doi: 10.1093/sleep/zsx075.
PubMed 28472528Pruiksma KE, Hale WJ, Mintz J, Peterson AL, Young-McCaughan S, Wilkerson A, Nicholson K, Dondanville KA, Fina BA, Borah EV, Roache JD, Litz BT, Bryan CJ, Taylor DJ; STRONG STAR Consortium. Predictors of Cognitive Behavioral Therapy for Insomnia (CBTi) Outcomes in Active-Duty U.S. Army Personnel. Behav Ther. 2020 Jul;51(4):522-534. doi: 10.1016/j.beth.2020.02.001. Epub 2020 Feb 14.
PubMed 32586427
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia
- ClinicalTrials.gov ID
- NCT01549899
- Acronym / sponsor ID
- W81XWH-10-1-0828
- Conditions
- Insomnia
- Keywords
- Insomnia, Cognitive, Behavioral, Therapy, Internet, Depression, Substance Use, Post-Tramatic Stress Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Daniel J. Taylor, Ph.D.University, hospital or other
- Collaborators
- United States Department of Defense, C.R.Darnall Army Medical Center, The University of Texas Health Science Center at San Antonio
- Study start
- Mar 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Posted 17 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to directly compare 6 sessions of in-person and Internet administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a Minimal Contact control (MC), within an active duty military population to determine the comparative benefits of these interventions on improvement in sleep as well as domains strongly related to insomnia such as depression, substance abuse, and PTSD symptoms. A total of 189 military personnel with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions (over 6 weeks) of CBTi (n=77), ICBTi (n=35), or a MC control (n=77) condition. The investigators will compare these three groups on subjective and objective measures of sleep. The CBTi and MC control groups will be compared on other variables of interest (e.g., depression, substance abuse, and PTSD symptoms) and predictors of outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-person CBT of Insomnia | Active comparator | Behavioral: In-person Cognitive Behavioral Therapy of InsomniaCBTi consisted of 6 weekly 60-minute sessions and included identical informational material. The treatments contained the following efficacious and commonly used modules of cognitive behavioral treatments for insomnia: Stimulus Control, Sleep Restriction, Sleep Hygiene, Relaxation Training, Cognitive Restructuring. |
| Internet CBT of Insomnia | Active comparator | Behavioral: Internet Cognitive Behavioral Therapy of InsomniaThe I-CBTi protocol was developed by the National Center for Telehealth and Technology with the first author (DJT) serving as the subject matter expert, and administered on the afterdeployment.org website. The information and instructions for I-CBTi were identical to in-person CBTi; however, their mode of delivery in I-CBTi is considerably different due to the constraints of its automated, online format. The lessons were presented as audio recordings accompanied by visual graphics and animations and several lessons, had interactive components such as games, quizzes, and prompts for participants to schedule healthy sleep habits. |
| Minimal Contact | No intervention | –Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic Insomnia as defined by Research Diagnostic Criteria (RDC) criteria41 Complaint of > 3 months (chronic insomnia) of disturbed sleep >3 nights/week (severe insomnia) as defined by at least one of the following as assessed by sleep diaries: Sleep Onset Latency of >30 min (initial insomnia) and/or Wake After Sleep-Onset of >30 min (middle insomnia) and/or Early Morning Awakening of >30 min before the desired wakeup time (late insomnia) and Sleep Efficiency < 85%
- Active Duty military member stationed at Fort Hood as assessed by self-report.
- History of having deployed in support of OIF or OEF as assessed by self-report. • Stable on psychotropic and/or hypnotic medications for at least one month as assessed by self-report and review of medical record.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| In-person Cognitive Behavioral Therapy of InsomniaIn-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education \& hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy). | Behavioural | In-person CBT of Insomnia |
| Internet Cognitive Behavioral Therapy of InsomniaThe ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its automated, online format. Each of the six ICBTi sessions was divided into lessons covering different aspects of each of the components. The lessons were presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components were included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits. | Behavioural | Internet CBT of Insomnia |
Primary outcome
Sleep Diary Sleep Efficiency
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Provides daily self-reports of bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine self-reported sleep efficiency (i.e., total sleep time/time in bed X 100). Other variable to be extracted will include total sleep time and total wake time.
10 secondary outcomes
Beck Depression Inventory II
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Substance Use
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Actigraphy
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
PTSD Check List-Military
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Beck Anxiety Inventory
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Insomnia Severity Index
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Epworth Sleepiness Scale
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Dysfunctional Beliefs and Attitudes About Sleep Scale
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Multidimensional Fatigue Inventory
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Veterans Rand 12-Item Health Survey
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29458705Taylor DJ, Wilkerson AK, Pruiksma KE, Williams JM, Ruggero CJ, Hale W, Mintz J, Organek KM, Nicholson KL, Litz BT, Young-McCaughan S, Dondanville KA, Borah EV, Brundige A, Peterson AL; STRONG STAR Consortium. Reliability of the Structured Clinical Interview for DSM-5 Sleep Disorders Module. J Clin Sleep Med. 2018 Mar 15;14(3):459-464. doi: 10.5664/jcsm.7000.
- Background: PubMed 34600107Peterson AL, Young-McCaughan S, Roache JD, Mintz J, Litz BT, Williamson DE, Resick PA, Foa EB, McGeary DD, Dondanville KA, Taylor DJ, Wachen JS, Fox PT, Bryan CJ, McLean CP, Pruiksma KE, Yarvis JS, Niles BL, Abdallah CG, Averill LA, Back SE, Baker MT, Blount TH, Borah AM, Borah EV, Brock MS, Brown LA, Burg MM, Cigrang JA, DeBeer BB, DeVoe ER, Fina BA, Flanagan JC, Fredman SJ, Gardner CL, Gatchel RR, Goodie JL, Gueorguieva R, Higgs JB, Jacoby VM, Kelly KM, Krystal JH, Lapiz-Bluhm MD, Lopez-Roca AL, Marx BP, Maurer DM, McDevitt-Murphy ME, McGeary CA, Meyer EC, Miles SR, Monson CM, Morilak DA, Moring JC, Mysliwiec V, Nicholson KL, Rauch SAM, Riggs DS, Rosen CS, Rudd MD, Schobitz RP, Schrader CC, Shinn AM, Shiroma PR, Sloan DM, Stern SL, Strong R, Vannoy SD, Young KA, Keane TM; STRONG STAR Consortium and the Consortium to Alleviate PTSD. STRONG STAR and the Consortium to Alleviate PTSD: Shaping the future of combat PTSD and related conditions in military and veteran populations. Contemp Clin Trials. 2021 Nov;110:106583. doi: 10.1016/j.cct.2021.106583. Epub 2021 Sep 29.
- Background: PubMed 31176888Brown LA, Zang Y, Benhamou K, Taylor DJ, Bryan CJ, Yarvis JS, Dondanville KA, Litz BT, Mintz J, Roache JD, Pruiksma KE, Fina BA, Young-McCaughan S, Peterson AL, Foa EB; STRONG STAR Consortium. Mediation of suicide ideation in prolonged exposure therapy for posttraumatic stress disorder. Behav Res Ther. 2019 Aug;119:103409. doi: 10.1016/j.brat.2019.103409. Epub 2019 May 23.
- Background: PubMed 33748530Brown LA, Bryan CJ, Butner JE, Tabares JV, Young-McCaughan S, Hale WJ, Fina BA, Foa EB, Resick PA, Taylor DJ, Coon H, Williamson DE, Dondanville KA, Borah EV, McLean CP, Wachen JS, Pruiksma KE, Hernandez AM, Litz BT, Mintz J, Yarvis JS, Borah AM, Nicholson KL, Maurer DM, Kelly KM, Peterson AL; STRONG STAR Consortium. Identifying suicidal subtypes and dynamic indicators of increasing and decreasing suicide risk in active duty military personnel: Study protocol. Contemp Clin Trials Commun. 2021 Feb 16;21:100752. doi: 10.1016/j.conctc.2021.100752. eCollection 2021 Mar.
- Background: PubMed 30252077Ben Barnes J, Presseau C, Jordan AH, Kline NK, Young-McCaughan S, Keane TM, Peterson AL, Litz BT; the Consortium to Alleviate PTSD. Common Data Elements in the Assessment of Military-Related PTSD Research Applied in the Consortium to Alleviate PTSD. Mil Med. 2019 May 1;184(5-6):e218-e226. doi: 10.1093/milmed/usy226.
- Results publication: PubMed 29618098Taylor DJ, Peterson AL, Pruiksma KE, Hale WJ, Young-McCaughan S, Wilkerson A, Nicholson K, Litz BT, Dondanville KA, Roache JD, Borah EV, Brundige A, Mintz J; STRONG STAR Consortium. Impact of cognitive behavioral therapy for insomnia disorder on sleep and comorbid symptoms in military personnel: a randomized clinical trial. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy069.
- Results publication: PubMed 28472528Taylor DJ, Peterson AL, Pruiksma KE, Young-McCaughan S, Nicholson K, Mintz J; STRONG STAR Consortium. Internet and In-Person Cognitive Behavioral Therapy for Insomnia in Military Personnel: A Randomized Clinical Trial. Sleep. 2017 Jun 1;40(6). doi: 10.1093/sleep/zsx075.
- Results publication: PubMed 32586427Pruiksma KE, Hale WJ, Mintz J, Peterson AL, Young-McCaughan S, Wilkerson A, Nicholson K, Dondanville KA, Fina BA, Borah EV, Roache JD, Litz BT, Bryan CJ, Taylor DJ; STRONG STAR Consortium. Predictors of Cognitive Behavioral Therapy for Insomnia (CBTi) Outcomes in Active-Duty U.S. Army Personnel. Behav Ther. 2020 Jul;51(4):522-534. doi: 10.1016/j.beth.2020.02.001. Epub 2020 Feb 14.
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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.
Daniel J Taylor, Ph.D. principal investigator
University of North Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing In-person Cognitive Behavioral Therapy of Insomnia and Internet Cognitive Behavioral Therapy of Insomnia in people with Insomnia, run by Daniel J. Taylor, Ph.D. 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 0 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 Apr 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2025). 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 Diary Sleep Efficiency (time frame: Change from Baseline to Post-Treatment and 6 month follow-up). 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 NCT01549899, which also lists 8 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 Apr 2025.