Posttraumatic Stress DisordersNCT02774642
Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)
A study testing CBTI-PE and Hygiene-PE in people with Posttraumatic Stress Disorders and Chronic Insomnia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study aims to examine whether integrating insomnia and PTSD treatment will enhance sleep, PTSD, and quality of life outcomes. This is a randomized control trial comparing integrated evidence based CBT-I into PE (CBTI-PE) versus to a non-active sleep component plus PE (hygiene-PE) to optimize PTSD, sleep, and… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Posttraumatic Stress Disorders, Chronic Insomnia
- What is being tested?
- CBTI-PE and Hygiene-PE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 30 Sep 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 19 years old
- Diagnosis of PTSD
- Meet diagnostic criteria for insomnia
- Enrolled at the VA San Diego Healthcare System (VASDHS) and living within 50 miles of the respective facility
- English literacy
Who cannot join
- Unmanaged psychosis or manic episodes in past year
- Substance/alcohol use disorder in past 6 months
- Diagnosed (previously or by the investigators' study screen) and untreated sleep disorder other than insomnia
- Sleep disorders diagnosed, but stably treated, such as obstructive sleep apnea treated with continuous positive airway pressure (CPAP), will be allowed)
- Participation in concurrent psychotherapies targeting PTSD
- Veteran can be reassessed after their PTSD treatment concludes
Show all 9Show fewer
- Veterans who are engaged in treatment for non-PTSD symptoms (e.g., 12-step programs) will be eligible
- Severe medical or psychiatric illness that would make it difficult to regularly attend psychotherapy sessions or participate fully in the study
- History of moderate to severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: The Impact of Integrated CBT-I and PE on Sleep and PTSD Outcomes
This study aims to examine whether integrating insomnia and PTSD treatment will enhance sleep, PTSD, and quality of life outcomes. This is a randomized control trial comparing integrated evidence based CBT-I into PE (CBTI-PE) versus to a non-active sleep component plus PE (hygiene-PE) to optimize PTSD, sleep, and quality of life outcomes in 90 Veterans. Such benefits would further the VA's commitment to improving the mental health, recovery, and community reintegration of Veterans detailed in the 2014-2020 VHA Strategic Plan. Findings from the proposed study offer a unique opportunity to determine the malleability of mechanisms (e.g., Total sleep time, Sleep efficiency) that can improve recovery outcomes among this vulnerable population and to inform future treatment development and research. Improved PTSD, insomnia, and quality of life outcomes can decrease risk of chronic impairment and ultimately help affected Veterans live richer, more productive lives.
Read the detailed description
The lifetime prevalence of posttraumatic stress disorder (PTSD) is approximately 30% among Vietnam Veterans and 11-17% among Iraq and Afghanistan Veterans. PTSD is associated with enormous health care costs, increased suicidality, depression, poorer quality of life and functioning, physical health, and increased substance use. Prolonged exposure (PE) is an efficacious treatment for Veterans with PTSD that decreases avoidance of feared, but safe, cues. Despite PE being one of the best available treatments for PTSD, 25 to 45% of PTSD patients still meet diagnostic criteria following treatment. High rates of comorbid disorders, such as insomnia, may interfere with the efficacy of PE and limit long-term rehabilitation outcomes.
Among Veterans with PTSD, sleep disturbances are nearly universal with 70 - 87% reporting comorbid insomnia. Untreated insomnia can persist for years, is independently associated with impaired health-related quality of life, does not resolve following PTSD treatment, and can exacerbate daytime PTSD symptoms.
Importantly, insomnia may interfere with the mechanisms of PE through safety learning, habituation to feared stimuli, emotional coping, emotional processing, and cognitive abilities necessary for successful treatment.
Despite this, insomnia is not a primary intervention for Veterans with PTSD. Given these factors, it is critical to evaluate whether treating insomnia prior to PTSD will improve PTSD symptoms and quality of life outcomes. Cognitive behavioral treatment for insomnia (CBT-I) is the first line treatment of chronic and severe insomnia, which produces lasting improvements in sleep. By using CBT-I prior to, and integrated with, PE offers several novel advantages that will: 1) increase client-centered treatment by addressing the number one subjective complaint among Veterans with PTSD; 2) enhance PTSD outcomes and non-response rates by addressing insomnia-related factors that interfere with PTSD treatment; 3) act as a stepping stone and help to engage patients who are not initially willing to engage in trauma-focused PE; 4) increase rehabilitation outcomes by addressing the two leading disorders that independently affect quality of life for Veterans; 5) allow patients to address both symptoms of insomnia and PTSD within a shortened timeframe; 6) increase continuity by allowing patients to work with a single provider; and 7) decrease the risk of attrition between referral clinics and waitlists. To date, no studies have capitalized on available evidence-based CBT-I prior to PE to improve insomnia, PTSD, and quality of life outcomes.
- Conditions
- Posttraumatic Stress Disorders, Chronic Insomnia
- Being tested
- CBTI-PE, Hygiene-PE
- Keywords
- PTSD, insomnia, CBT-I, Prolonged Exposure, Veteran
- 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.
CBTI-PEBehavioural
Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence
Hygiene-PEBehavioural
The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.
| Study group | Role | What they receive |
|---|---|---|
| CBTI-PE | Experimental | Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions. Receives: Behavioral: CBTI-PE |
| Hygiene-PE | Active comparator | Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. Receives: Behavioral: Hygiene-PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptoms
PTSD Symptoms will be assessed using the Clinician-Administered PTSD Scale DSM 5 (CAPS-5). Range (0 - 80). Lower scores equate to lower PTSD severity. Change in PTSD will be assessed longitudinally using linear mixed effects models of the CAPS-5 at each timepoint to estimate slope (change) over time.
Measured: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
Change in Sleep Efficiency
Change in sleep efficiency. Sleep efficiency is calculated from two variables acquired from daily sleep logs filled out by patient: a) time spend in bed and b) time spent asleep. Sleep efficiency = time spent asleep / time spent in bed. Range (0 -100%). Higher sleep efficiency is better. Change in Sleep Efficiency will be assessed longitudinally using linear mixed effects models of measure at each timepoint to estimate slope (change) over time.
Measured: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
Secondary outcomes (2)
Change in Quality of Life
Change in Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire. All subscores, higher scores equate to better quality of life. Physical Health Range (7-35); Psychological Range (6-30); Social Relationships (3-15); Environment (8-40).
Measured: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
Change in Insomnia Severity
Insomnia Severity will be assessed using the Insomnia Severity Index (ISI). Range (0 - 28). Lower scores equate to lower insomnia severity. Change in ISI will be assessed longitudinally using linear mixed effects models of the ISI scores at each timepoint to estimate slope (change) over time.
Measured: Baseline, week 5, Post Treatment (14-weeks), Follow-up (26-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start1 Oct 2016
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
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 (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Peter Colvonen, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774642
- Sponsor's protocol ID
- D2120-W
- Other IDs
- 1lK2Rx002120-01
- Status last verified
- Sep 2024
- First submitted
- 10 May 2016
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colvonen PJ, Hunt C, Park J, Angkaw AC, Gehrman P, Clare K, Norman SB. Cognitive Behavioral Therapy for Insomnia With Prolonged Exposure Compared to Sleep Hygiene and Prolonged Exposure: A Randomized Controlled Trial. J Clin Psychiatry. 2025 Jun 4;86(3):24m15584. doi: 10.4088/JCP.24m15584.
PubMed 40488726Park J, Hunt C, Abirgas K, Bomyea J, Colvonen PJ. Veterans who focus on sexual assault trauma show slower between-session habituation and symptom reduction during prolonged exposure treatment for posttraumatic stress disorder. Psychol Trauma. 2025 Jan;17(1):38-47. doi: 10.1037/tra0001536. Epub 2023 Jun 19.
PubMed 37338445Lyons R, Barbir LA, Owens R, Colvonen PJ. STOP-BANG screener vs objective obstructive sleep apnea testing among younger veterans with PTSD and insomnia: STOP-BANG does not sufficiently detect risk. J Clin Sleep Med. 2022 Jan 1;18(1):67-73. doi: 10.5664/jcsm.9498.
PubMed 34216197
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Integrated CBT-I and PE on Sleep and PTSD Outcomes
- ClinicalTrials.gov ID
- NCT02774642
- Acronym / sponsor ID
- D2120-W
- Conditions
- Posttraumatic Stress Disorders, Chronic Insomnia
- Keywords
- PTSD, insomnia, CBT-I, Prolonged Exposure, Veteran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine whether integrating insomnia and PTSD treatment will enhance sleep, PTSD, and quality of life outcomes. This is a randomized control trial comparing integrated evidence based CBT-I into PE (CBTI-PE) versus to a non-active sleep component plus PE (hygiene-PE) to optimize PTSD, sleep, and quality of life outcomes in 90 Veterans. Such benefits would further the VA's commitment to improving the mental health, recovery, and community reintegration of Veterans detailed in the 2014-2020 VHA Strategic Plan. Findings from the proposed study offer a unique opportunity to determine the malleability of mechanisms (e.g., Total sleep time, Sleep efficiency) that can improve recovery outcomes among this vulnerable population and to inform future treatment development and research. Improved PTSD, insomnia, and quality of life outcomes can decrease risk of chronic impairment and ultimately help affected Veterans live richer, more productive lives.
Detailed description
The lifetime prevalence of posttraumatic stress disorder (PTSD) is approximately 30% among Vietnam Veterans and 11-17% among Iraq and Afghanistan Veterans. PTSD is associated with enormous health care costs, increased suicidality, depression, poorer quality of life and functioning, physical health, and increased substance use. Prolonged exposure (PE) is an efficacious treatment for Veterans with PTSD that decreases avoidance of feared, but safe, cues. Despite PE being one of the best available treatments for PTSD, 25 to 45% of PTSD patients still meet diagnostic criteria following treatment. High rates of comorbid disorders, such as insomnia, may interfere with the efficacy of PE and limit long-term rehabilitation outcomes.
Among Veterans with PTSD, sleep disturbances are nearly universal with 70 - 87% reporting comorbid insomnia. Untreated insomnia can persist for years, is independently associated with impaired health-related quality of life, does not resolve following PTSD treatment, and can exacerbate daytime PTSD symptoms.
Importantly, insomnia may interfere with the mechanisms of PE through safety learning, habituation to feared stimuli, emotional coping, emotional processing, and cognitive abilities necessary for successful treatment.
Despite this, insomnia is not a primary intervention for Veterans with PTSD. Given these factors, it is critical to evaluate whether treating insomnia prior to PTSD will improve PTSD symptoms and quality of life outcomes. Cognitive behavioral treatment for insomnia (CBT-I) is the first line treatment of chronic and severe insomnia, which produces lasting improvements in sleep. By using CBT-I prior to, and integrated with, PE offers several novel advantages that will: 1) increase client-centered treatment by addressing the number one subjective complaint among Veterans with PTSD; 2) enhance PTSD outcomes and non-response rates by addressing insomnia-related factors that interfere with PTSD treatment; 3) act as a stepping stone and help to engage patients who are not initially willing to engage in trauma-focused PE; 4) increase rehabilitation outcomes by addressing the two leading disorders that independently affect quality of life for Veterans; 5) allow patients to address both symptoms of insomnia and PTSD within a shortened timeframe; 6) increase continuity by allowing patients to work with a single provider; and 7) decrease the risk of attrition between referral clinics and waitlists. To date, no studies have capitalized on available evidence-based CBT-I prior to PE to improve insomnia, PTSD, and quality of life outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBTI-PE | Experimental | Behavioral: CBTI-PEIntegrates the core components of CBT-I and PE in 14 90-minute weekly sessions. |
| Hygiene-PE | Active comparator | Behavioral: Hygiene-PEUses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over the age of 19 years old
- Diagnosis of PTSD
- Meet diagnostic criteria for insomnia
- Enrolled at the VA San Diego Healthcare System (VASDHS) and living within 50 miles of the respective facility
- English literacy
Key exclusion criteria (9 listed)
- Unmanaged psychosis or manic episodes in past year
- Substance/alcohol use disorder in past 6 months
- Diagnosed (previously or by the investigators' study screen) and untreated sleep disorder other than insomnia
- Participation in concurrent psychotherapies targeting PTSD
- Severe medical or psychiatric illness that would make it difficult to regularly attend psychotherapy sessions or participate fully in the study
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 |
|---|---|---|
| CBTI-PEIntegrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence | Behavioural | CBTI-PE |
| Hygiene-PEThe investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4. | Behavioural | Hygiene-PE |
Primary outcome
Change in PTSD Symptoms
Time frame: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
PTSD Symptoms will be assessed using the Clinician-Administered PTSD Scale DSM 5 (CAPS-5). Range (0 - 80). Lower scores equate to lower PTSD severity. Change in PTSD will be assessed longitudinally using linear mixed effects models of the CAPS-5 at each timepoint to estimate slope (change) over time.
Change in Sleep Efficiency
Time frame: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
Change in sleep efficiency. Sleep efficiency is calculated from two variables acquired from daily sleep logs filled out by patient: a) time spend in bed and b) time spent asleep. Sleep efficiency = time spent asleep / time spent in bed. Range (0 -100%). Higher sleep efficiency is better. Change in Sleep Efficiency will be assessed longitudinally using linear mixed effects models of measure at each timepoint to estimate slope (change) over time.
2 secondary outcomes
Change in Quality of Life
Time frame: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
Change in Insomnia Severity
Time frame: Baseline, week 5, Post Treatment (14-weeks), Follow-up (26-weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40488726Colvonen PJ, Hunt C, Park J, Angkaw AC, Gehrman P, Clare K, Norman SB. Cognitive Behavioral Therapy for Insomnia With Prolonged Exposure Compared to Sleep Hygiene and Prolonged Exposure: A Randomized Controlled Trial. J Clin Psychiatry. 2025 Jun 4;86(3):24m15584. doi: 10.4088/JCP.24m15584.
- Derived from this study: PubMed 37338445Park J, Hunt C, Abirgas K, Bomyea J, Colvonen PJ. Veterans who focus on sexual assault trauma show slower between-session habituation and symptom reduction during prolonged exposure treatment for posttraumatic stress disorder. Psychol Trauma. 2025 Jan;17(1):38-47. doi: 10.1037/tra0001536. Epub 2023 Jun 19.
- Derived from this study: PubMed 34216197Lyons R, Barbir LA, Owens R, Colvonen PJ. STOP-BANG screener vs objective obstructive sleep apnea testing among younger veterans with PTSD and insomnia: STOP-BANG does not sufficiently detect risk. J Clin Sleep Med. 2022 Jan 1;18(1):67-73. doi: 10.5664/jcsm.9498.
- Individual participant dataSharing planned: No
Related trials for Posttraumatic Stress Disorders
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
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.
Peter Colvonen, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBTI-PE and Hygiene-PE in people with Posttraumatic Stress Disorders and Chronic Insomnia, run by VA Office of Research and Development 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 5 inclusion and 9 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 8 Oct 2024. 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 8 Oct 2024). 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?
Change in PTSD Symptoms (time frame: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)). 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 NCT02774642, which also lists 3 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 8 Oct 2024.