Posttraumatic Stress DisorderNCT05950035
An Efficient Treatment for Posttraumatic Injury for Firefighters
A study testing Written Exposure Therapy (WET), Cognitive Behavioral Therapy for Insomnia (CBTi) and Cognitive Behavioral Therapy for Nightmares (CBTn) in people with Posttraumatic Stress Disorder and Insomnia, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
The goal of this two-arm pilot randomized controlled trial is to test a behavioral intervention that integrates three evidence-based cognitive behavioral interventions (written exposure therapy; WET, cognitive behavioral therapy for insomnia; CBT-I, and cognitive behavioral therapy for nightmares; CBT-N) among… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Insomnia, Nightmare
- What is being tested?
- Written Exposure Therapy (WET), Cognitive Behavioral Therapy for Insomnia (CBTi) and Cognitive Behavioral Therapy for Nightmares (CBTn)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Firefighter
- Able to speak and read English
- Clinically significant posttraumatic stress symptoms: CAPS-5 total score ≥ 25; ≥ 1 intrusion symptom; ≥ 1 avoidance symptom
- Clinically significant symptoms of insomnia: SCISD insomnia criteria are met; ISI ≥ 15
- Clinically significant symptoms of nightmare disorder: SCISD nightmare disorder criteria are met, nightmares ≥ 1 monthly.
Who cannot join
- Current suicide or homicide risk meriting crisis intervention
- Inability to speak and read English
- Inability to comprehend the baseline screening questionnaires
- Unwilling to remain abstinent from alcohol during treatment
- Serious mental health diagnosis such as bipolar disorder or psychosis.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this two-arm pilot randomized controlled trial is to test a behavioral intervention that integrates three evidence-based cognitive behavioral interventions (written exposure therapy; WET, cognitive behavioral therapy for insomnia; CBT-I, and cognitive behavioral therapy for nightmares; CBT-N) among firefighters. The main questions it aims to answer are:
- Is the behavioral intervention feasible, acceptable, and effective in reducing symptoms of posttraumatic stress, insomnia, and nightmares?
- What is the efficacy of efficient treatment vs. delayed treatment (2-4 week waitlist) in reducing symptoms of posttraumatic stress, insomnia, and nightmares?
Read more
We will beta test the intervention in 1-2 groups of 3-5 firefighters. Then we will randomize 50 participants to immediate or delayed (2-4 week waitlist) treatment. Consented participants will:
- Complete self-report and interview measures assessing posttraumatic stress disorder, insomnia (PTSD), and nightmares
- Attend an individual treatment orientation session
- Attend a 4-day (~3 hours per day over 4 consecutive days) group treatment that integrates WET, CBT-I, and CBT-N
- Attend an individual booster session held approximately one week later
- Complete self-report measures before, during, and after treatment, and at a 3-month follow up assessment and a clinical interview before and after treatment to assess program efficacy.
- Conditions
- Posttraumatic Stress Disorder, Insomnia, Nightmare
- Being tested
- Written Exposure Therapy (WET), Cognitive Behavioral Therapy for Insomnia (CBTi), Cognitive Behavioral Therapy for Nightmares (CBTn), Waitlist
- 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.
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.
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.
WaitlistBehavioural
Waitlist for delayed intervention.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Will begin treatment within 2 weeks of randomization. Receives: Behavioral: Written Exposure Therapy (WET); Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi); Behavioral: Cognitive Behavioral Therapy for Nightmares (CBTn) |
| Delayed Intervention | Active comparator | Will be scheduled to begin treatment within 4-6 weeks of randomization. Receives: Behavioral: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS-5)
The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms.
Measured: Change from baseline to post treatment (~4 weeks post baseline)
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 post treatment (~4 weeks post baseline)
Insomnia Severity Index (ISI)
The ISI assesses perceived severity of insomnia.
Measured: Change from baseline through 3 months post treatment
Nightmare Disorders Index
The NDI is a self-report assessment of nightmare disorder.
Measured: Change from baseline through 3 months post treatment
Posttraumatic Stress Disorder Checklist (PCL-5)
Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5.
Measured: Change from baseline through 3 months post treatment
Secondary outcomes (6)
Trauma-Related Nightmare Survey (TRNS)
The TRNS assesses nightmare frequency, disturbance, and characteristics.
Measured: Change from baseline through 3 months post treatment
Self-Assessment of Sleep (SASS)
The SASS is a brief assessment of self-reported sleep quantity and sleep quality.
Measured: Change from baseline through 3 months post treatment
Sleep Diary and Nightmare Log
The Sleep Diary and Nightmare Log assess daily subjective sleep patterns and to inform treatment recommendations.
Measured: Change from baseline through post treatment (~4 weeks post baseline)
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 the severity of affective and somatic symptoms related to depression; items correspond to the diagnostic criteria for major depression disorder.
Measured: Change from baseline through 3 months post treatment
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.
Measured: Change from baseline through 3 months post treatment
Net Prompter Score
The Net Prompter Score is a single item measures of treatment acceptability that asks respondents to rate the likelihood that they would recommend the efficient treatment to a friend or colleague on a scale from 0-10.
Measured: Post treatment (~4 weeks post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Dec 2023
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona, Oregon State University, Boston University, The University of Texas Health Science Center at San Antonio, National Development and Research Institutes, Inc.
- Responsible party
- Principal investigator, Carmen McLean, Palo Alto Veterans Institute for Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950035
- Sponsor's protocol ID
- MCA0006AGG
- Status last verified
- May 2025
- First submitted
- 5 Jun 2023
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McLean CP, Janke S, Pruiksma KE, Taylor DJ, Sloan DM, Dietch JR, Fredman SJ, Sutherland C, Hollerbach B, Thompson SM, Tse D, Nagy S, Malek N, Haddock CK. A pilot feasibility randomized clinical trial of a culturally adapted accelerated group treatment for posttraumatic stress, insomnia, and nightmares in firefighters. Psychol Trauma. 2026 Jan 19. doi: 10.1037/tra0002090. Online ahead of print.
PubMed 41556892
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficient Treatment for Posttraumatic Injury for Firefighters
- ClinicalTrials.gov ID
- NCT05950035
- Acronym / sponsor ID
- MCA0006AGG
- Conditions
- Posttraumatic Stress Disorder, Insomnia, Nightmare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- University of Arizona, Oregon State University, Boston University, The University of Texas Health Science Center at San Antonio, National Development and Research Institutes, Inc.
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 18 Jul 2023 (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.
The goal of this two-arm pilot randomized controlled trial is to test a behavioral intervention that integrates three evidence-based cognitive behavioral interventions (written exposure therapy; WET, cognitive behavioral therapy for insomnia; CBT-I, and cognitive behavioral therapy for nightmares; CBT-N) among firefighters. The main questions it aims to answer are:
- Is the behavioral intervention feasible, acceptable, and effective in reducing symptoms of posttraumatic stress, insomnia, and nightmares?
- What is the efficacy of efficient treatment vs. delayed treatment (2-4 week waitlist) in reducing symptoms of posttraumatic stress, insomnia, and nightmares?
We will beta test the intervention in 1-2 groups of 3-5 firefighters. Then we will randomize 50 participants to immediate or delayed (2-4 week waitlist) treatment. Consented participants will:
- Complete self-report and interview measures assessing posttraumatic stress disorder, insomnia (PTSD), and nightmares
- Attend an individual treatment orientation session
- Attend a 4-day (~3 hours per day over 4 consecutive days) group treatment that integrates WET, CBT-I, and CBT-N
- Attend an individual booster session held approximately one week later
- Complete self-report measures before, during, and after treatment, and at a 3-month follow up assessment and a clinical interview before and after treatment to assess program efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Written Exposure Therapy (WET), Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi), Behavioral: Cognitive Behavioral Therapy for Nightmares (CBTn)Will begin treatment within 2 weeks of randomization. |
| Delayed Intervention | Active comparator | Behavioral: WaitlistWill be scheduled to begin treatment within 4-6 weeks of randomization. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65 years old
- Firefighter
- Able to speak and read English
- Clinically significant posttraumatic stress symptoms: CAPS-5 total score ≥ 25; ≥ 1 intrusion symptom; ≥ 1 avoidance symptom
- Clinically significant symptoms of insomnia: SCISD insomnia criteria are met; ISI ≥ 15
Key exclusion criteria (5 listed)
- Current suicide or homicide risk meriting crisis intervention
- Inability to speak and read English
- Inability to comprehend the baseline screening questionnaires
- Unwilling to remain abstinent from alcohol during treatment
- Serious mental health diagnosis such as bipolar disorder or psychosis.
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 |
|---|---|---|
| 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 | Immediate Intervention |
| 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 | Immediate Intervention |
| 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 | Immediate Intervention |
| WaitlistWaitlist for delayed intervention. | Behavioural | Delayed Intervention |
Primary outcome
Clinician Administered PTSD Scale (CAPS-5)
Time frame: Change from baseline to post treatment (~4 weeks post baseline)
The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms.
Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)
Time frame: Change from baseline to post treatment (~4 weeks post baseline)
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.
Insomnia Severity Index (ISI)
Time frame: Change from baseline through 3 months post treatment
The ISI assesses perceived severity of insomnia.
Nightmare Disorders Index
Time frame: Change from baseline through 3 months post treatment
The NDI is a self-report assessment of nightmare disorder.
Posttraumatic Stress Disorder Checklist (PCL-5)
Time frame: Change from baseline through 3 months post treatment
Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5.
6 secondary outcomes
Trauma-Related Nightmare Survey (TRNS)
Time frame: Change from baseline through 3 months post treatment
Self-Assessment of Sleep (SASS)
Time frame: Change from baseline through 3 months post treatment
Sleep Diary and Nightmare Log
Time frame: Change from baseline through post treatment (~4 weeks post baseline)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from baseline through 3 months post treatment
Depressive Symptoms Index-Suicidality Subscale (DSI-SS)
Time frame: Change from baseline through 3 months post treatment
Net Prompter Score
Time frame: Post treatment (~4 weeks post baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Derived from this study: PubMed 41556892McLean CP, Janke S, Pruiksma KE, Taylor DJ, Sloan DM, Dietch JR, Fredman SJ, Sutherland C, Hollerbach B, Thompson SM, Tse D, Nagy S, Malek N, Haddock CK. A pilot feasibility randomized clinical trial of a culturally adapted accelerated group treatment for posttraumatic stress, insomnia, and nightmares in firefighters. Psychol Trauma. 2026 Jan 19. doi: 10.1037/tra0002090. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy (WET), Cognitive Behavioral Therapy for Insomnia (CBTi) and Cognitive Behavioral Therapy for Nightmares (CBTn) in people with Posttraumatic Stress Disorder and Insomnia, 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 5 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 31 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinician Administered PTSD Scale (CAPS-5) (time frame: Change from baseline to post treatment (~4 weeks post baseline)). The study lists 5 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 NCT05950035, which also lists 1 linked publication.
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 31 May 2025.