InsomniaNCT07069517
Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD
A study testing Cognitive-Behavioral Therapy for Insomnia (CBTi), Cognitive Behavioral Therapy for Nightmares (CBTn) and Written Exposure Therapy (WET) in people with Insomnia and PTSD - Post Traumatic Stress Disorder, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
This study is a two-arm individually randomized group treatment clinical trial evaluating behavioral therapies for insomnia, nightmares, and PTSD. The study will compare cognitive-behavioral therapy for insomnia and nightmares to sleep hygiene (Control), both integrated with Written Exposure Therapy for PTSD and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, PTSD - Post Traumatic Stress Disorder, Nightmares
- What is being tested?
- Cognitive-Behavioral Therapy for Insomnia (CBTi), Cognitive Behavioral Therapy for Nightmares (CBTn) and Written Exposure Therapy (WET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Defense Enrollment Eligibility Reporting System (DEERS) eligible active-duty military personnel or veteran, 18-65 years old.
- Ability to speak and read English.
- Clinically significant PTSD symptoms (CAPS-5 > 25 with at least one Intrusion symptom and at least one Avoidance symptom).
- Clinically significant symptoms of insomnia disorder (Structured Clinical Interview for Sleep Disturbance DSM-5 (SCISD) Insomnia Criteria are met and Insomnia Severity Index (ISI) > 11).
- Nightmares > 1 monthly (as reported on the SCISD).
- Willing to refrain from new behavioral health or medication treatment for issues pertaining to PTSD, sleep, and nightmares during study participation.
Who cannot join
- Current suicide or homicide risk meriting crisis intervention.
- Inability to comprehend the baseline screening questionnaires.
- Unwilling to remain abstinent from alcohol during therapy sessions.
- Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.
- Currently engaged in evidence-based psychotherapy for PTSD (e.g., Prolonged Exposure Therapy, Cognitive Processing Therapy, Written Exposure Therapy) or insomnia or nightmares (e.g., Cognitive Behavioral Therapy for Insomnia or Nightmares).
- Pregnancy, as determined by self-report, because pregnancy can adversely affect sleep outside of PTSD, insomnia, and nightmares.
- Working duty shifts ending later than 21:00 or starting before 05:30 more than 2 times per month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fort Hood
Kileen, Texas, 76544
Bryce Williams, 210-562-6700, williamsB7@uthscsa.edu
About this study
Official title: Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD: A Randomized Controlled Trial
This study is a two-arm individually randomized group treatment clinical trial evaluating behavioral therapies for insomnia, nightmares, and PTSD. The study will compare cognitive-behavioral therapy for insomnia and nightmares to sleep hygiene (Control), both integrated with Written Exposure Therapy for PTSD and delivered in an accelerated (i.e., 5-day) group treatment format, preceded and followed by individual treatment sessions. 160 participants will be randomized into one of two study conditions.
Read the detailed description
The aims of the study are:
- Determine the efficacy of accelerated cognitive behavioral therapy for insomnia and nightmares (CBTi+n) integrated with Written Exposure Therapy (WET) for PTSD for improving insomnia symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.
- Determine the efficacy of accelerated CBTi+n integrated with WET for improving nightmare symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.
Exploratory Aim: Determine the efficacy of accelerated CBTi+n integrated with WET for improving PTSD symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.
- Conditions
- Insomnia, PTSD - Post Traumatic Stress Disorder, Nightmares
- Being tested
- Cognitive-Behavioral Therapy for Insomnia (CBTi), Cognitive Behavioral Therapy for Nightmares (CBTn), Written Exposure Therapy (WET), Sleep Hygiene
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy for Insomnia (CBTi)Behavioural
CBTi focuses on stimulus control, eliminating maladaptive coping habits, reducing arousal, and challenging maladaptive thoughts about sleep in an effort to reduce time to fall asleep and time awake during the night.
Cognitive Behavioral Therapy for Nightmares (CBTn)Behavioural
CBTn involves writing about a distressing or frequent nightmare, rewriting the narrative of the nightmare to target trauma-related themes, and reading the rescripted nightmare narrative.
Written Exposure Therapy (WET)Behavioural
WET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist.
Sleep HygieneBehavioural
Involves reviewing sleep diary data, sleep education, and reviewing and discussing sleep hygiene practices.
| Study group | Role | What they receive |
|---|---|---|
| Written exposure therapy and sleep hygiene for insomnia and nightmares | Active comparator | Not described Receives: Behavioral: Written Exposure Therapy (WET); Behavioral: Sleep Hygiene |
| Written exposure therapy and CBT for insomnia and nightmares | Experimental | Not described Receives: Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBTi); Behavioral: Cognitive Behavioral Therapy for Nightmares (CBTn); Behavioral: Written Exposure Therapy (WET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Disorder Checklist (PCL-5)
Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. Total scores range from 0-80 (higher scores indicate greater PTSD severity).
Measured: Change from baseline through 3 and 6 month follow-up assessment
Insomnia Severity Index (ISI)
The ISI assesses perceived severity of insomnia. Total scores range from 0-28 (higher scores indicate greater insomnia severity).
Measured: Change from baseline through 3 and 6 month follow up
Nightmare Disorders Index
The NDI is a self-report assessment of nightmare disorder.
Measured: Change from baseline through 3 and 6 month assessments
Secondary outcomes (7)
Clinician Administered PTSD Scale (CAPS-5)
The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms. Total scores range from 0-80 (higher scores indicate greater PTSD severity).
Measured: Change from baseline to 1-month follow-up assessment
Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)
The SCISD-R is a semi-structured interview designed to obtain a sleep history and screen for certain sleep disorders and diagnose others, including insomnia, hypersomnia, circadian rhythm sleep-wake disorders, sleep-disordered breathing, and parasomnias.
Measured: Change from baseline to 1-month follow-up assessment
Generalized Anxiety Disorder Screener (GAD-7)
GAD-7 is a 7-item measure that assesses generalized anxiety symptomology. Total scores range from 0-21 (higher scores indicate greater anxiety).
Measured: Change from baseline through 3 and 6 month follow-up assessment
Trauma-Related Nightmare Survey (TRNS)
The TRNS assesses nightmare frequency, disturbance, and characteristics
Measured: Change from baseline through 3 and 6 month follow-up assessment
Depressive Symptoms Index-Suicidality Subscale (DSI-SS)
The DSI-SS is a self-report measure of suicidal ideation, plans, perceived control over ideation, and impulses for suicide. Total scores range from 0-12 (higher scores indicate greater suicidality).
Measured: Change from baseline through 3 and 6 month follow up assessment
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 assess the severity of affective and somatic symptoms related to depression; items correspond to the diagnostic criteria for major depression disorder. Total scores range from 0-27 (higher scores indicate greater depressive symptom severity).
Measured: Change from baseline through 3 and 6 follow-up assessment
Brief Inventory of Psychosocial Functioning (B-IPF)
B-IPF is a 7-item measure of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living. Total scores range from 0-42 (higher scores indicate greater functional impairment).
Measured: Change from baseline through 3 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 posted16 Jul 2025
- Study start2 Dec 2025 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, University of Arizona, NDRI-USA, Inc.
- Responsible party
- Principal investigator, Carmen McLean, Palo Alto Veterans Institute for Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069517
- Sponsor's protocol ID
- MCA0010
- Status last verified
- Dec 2025
- First submitted
- 7 Jul 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data used to conduct these analyses are stored in the STRONG STAR Repository. Deidentified data can be accessed by emailing repository@strongstar.org
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07069517
- Acronym / sponsor ID
- MCA0010
- Conditions
- Insomnia, PTSD - Post Traumatic Stress Disorder, Nightmares
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, University of Arizona, NDRI-USA, Inc.
- Study start
- 2 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 16 Jul 2025 (actual)
- 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.
This study is a two-arm individually randomized group treatment clinical trial evaluating behavioral therapies for insomnia, nightmares, and PTSD. The study will compare cognitive-behavioral therapy for insomnia and nightmares to sleep hygiene (Control), both integrated with Written Exposure Therapy for PTSD and delivered in an accelerated (i.e., 5-day) group treatment format, preceded and followed by individual treatment sessions. 160 participants will be randomized into one of two study conditions.
Detailed description
The aims of the study are:
- Determine the efficacy of accelerated cognitive behavioral therapy for insomnia and nightmares (CBTi+n) integrated with Written Exposure Therapy (WET) for PTSD for improving insomnia symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.
- Determine the efficacy of accelerated CBTi+n integrated with WET for improving nightmare symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.
Exploratory Aim: Determine the efficacy of accelerated CBTi+n integrated with WET for improving PTSD symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written exposure therapy and sleep hygiene for insomnia and nightmares | Active comparator | Behavioral: Written Exposure Therapy (WET), Behavioral: Sleep Hygiene |
| Written exposure therapy and CBT for insomnia and nightmares | Experimental | Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBTi), Behavioral: Cognitive Behavioral Therapy for Nightmares (CBTn), Behavioral: Written Exposure Therapy (WET) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Defense Enrollment Eligibility Reporting System (DEERS) eligible active-duty military personnel or veteran, 18-65 years old.
- Ability to speak and read English.
- Clinically significant PTSD symptoms (CAPS-5 > 25 with at least one Intrusion symptom and at least one Avoidance symptom).
- Clinically significant symptoms of insomnia disorder (Structured Clinical Interview for Sleep Disturbance DSM-5 (SCISD) Insomnia Criteria are met and Insomnia Severity Index (ISI) > 11).
- Nightmares > 1 monthly (as reported on the SCISD).
Key exclusion criteria (7 listed)
- Current suicide or homicide risk meriting crisis intervention.
- Inability to comprehend the baseline screening questionnaires.
- Unwilling to remain abstinent from alcohol during therapy sessions.
- Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.
- Currently engaged in evidence-based psychotherapy for PTSD (e.g., Prolonged Exposure Therapy, Cognitive Processing Therapy, Written Exposure Therapy) or insomnia or nightmares (e.g., Cognitive Behavioral Therapy for Insomnia or Nightmares).
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 Therapy for Insomnia (CBTi)CBTi focuses on stimulus control, eliminating maladaptive coping habits, reducing arousal, and challenging maladaptive thoughts about sleep in an effort to reduce time to fall asleep and time awake during the night. | Behavioural | Written exposure therapy and CBT for insomnia and nightmares |
| Cognitive Behavioral Therapy for Nightmares (CBTn)CBTn involves writing about a distressing or frequent nightmare, rewriting the narrative of the nightmare to target trauma-related themes, and reading the rescripted nightmare narrative. | Behavioural | Written exposure therapy and CBT for insomnia and nightmares |
| Written Exposure Therapy (WET)WET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist. | Behavioural | Written exposure therapy and CBT for insomnia and nightmares, Written exposure therapy and sleep hygiene for insomnia and nightmares |
| Sleep HygieneInvolves reviewing sleep diary data, sleep education, and reviewing and discussing sleep hygiene practices. | Behavioural | Written exposure therapy and sleep hygiene for insomnia and nightmares |
Primary outcome
Posttraumatic Stress Disorder Checklist (PCL-5)
Time frame: Change from baseline through 3 and 6 month follow-up assessment
Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. Total scores range from 0-80 (higher scores indicate greater PTSD severity).
Insomnia Severity Index (ISI)
Time frame: Change from baseline through 3 and 6 month follow up
The ISI assesses perceived severity of insomnia. Total scores range from 0-28 (higher scores indicate greater insomnia severity).
Nightmare Disorders Index
Time frame: Change from baseline through 3 and 6 month assessments
The NDI is a self-report assessment of nightmare disorder.
7 secondary outcomes
Clinician Administered PTSD Scale (CAPS-5)
Time frame: Change from baseline to 1-month follow-up assessment
Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)
Time frame: Change from baseline to 1-month follow-up assessment
Generalized Anxiety Disorder Screener (GAD-7)
Time frame: Change from baseline through 3 and 6 month follow-up assessment
Trauma-Related Nightmare Survey (TRNS)
Time frame: Change from baseline through 3 and 6 month follow-up assessment
Depressive Symptoms Index-Suicidality Subscale (DSI-SS)
Time frame: Change from baseline through 3 and 6 month follow up assessment
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from baseline through 3 and 6 follow-up assessment
Brief Inventory of Psychosocial Functioning (B-IPF)
Time frame: Change from baseline through 3 and 6 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Yes. The data used to conduct these analyses are stored in the STRONG STAR Repository. Deidentified data can be accessed by emailing repository@strongstar.org
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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.
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 Therapy for Insomnia (CBTi), Cognitive Behavioral Therapy for Nightmares (CBTn) and Written Exposure Therapy (WET) in people with Insomnia and PTSD - Post Traumatic Stress Disorder, run by Palo Alto Veterans Institute for Research 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 3 Dec 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmen McLean, PhD (650-614-9997, carmen.mclean4@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Disorder Checklist (PCL-5) (time frame: Change from baseline through 3 and 6 month follow-up assessment). 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?
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 3 Dec 2025.