~21 spots leftby Apr 2026

Integrated Therapies for PTSD

Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Palo Alto Veterans Institute for Research
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for firefighters aged 18-65 with posttraumatic stress symptoms, insomnia, and nightmares. They must speak English and have a certain level of PTSD severity (CAPS-5 score ≥ 25), frequent nightmares (at least once a month), and significant insomnia (ISI ≥ 15). Those at risk of harming themselves or others, unable to understand the questionnaires, using alcohol during treatment, or with serious mental health conditions like bipolar disorder or psychosis cannot join.

Inclusion Criteria

I am between 18 and 65 years old.
Firefighter
Able to speak and read English
See 3 more

Exclusion Criteria

Current suicide or homicide risk meriting crisis intervention
Inability to comprehend the baseline screening questionnaires
Unwilling to remain abstinent from alcohol during treatment
See 2 more

Treatment Details

Interventions

  • Cognitive Behavioral Therapy for Insomnia (CBTi) (Behavioural Intervention)
  • Cognitive Behavioral Therapy for Nightmares (CBTn) (Behavioural Intervention)
  • Waitlist (Behavioural Intervention)
  • Written Exposure Therapy (WET) (Behavioural Intervention)
Trial OverviewThe study tests an integrated behavioral therapy combining Written Exposure Therapy (WET) with Cognitive Behavioral Therapies for Insomnia (CBTi) and Nightmares (CBTn). It checks if this approach is workable, acceptable, and effective compared to delayed treatment. Participants will undergo group sessions over four days followed by a booster session and assessments before, during after treatment as well as three months later.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate InterventionExperimental Treatment3 Interventions
Will begin treatment within 2 weeks of randomization.
Group II: Delayed InterventionActive Control1 Intervention
Will be scheduled to begin treatment within 4-6 weeks of randomization.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Palo Alto Veterans Institute for Research

Lead Sponsor

Trials
58
Recruited
8,800+

University of Arizona

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Dr. Richard Carmona

University of Arizona

Chief Medical Officer since 2021

MD, University of Arizona

Dr. Evan Unger profile image

Dr. Evan Unger

University of Arizona

Chief Executive Officer since 2021

PhD in Medical Imaging, University of Arizona

Oregon State University

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Sophie Kornowski profile image

Sophie Kornowski

Boston University

Chief Executive Officer since 2022

MBA from the University of Chicago, Doctorate in Pharmacy from Paris Descartes University

Dr. Patrizia Cavazzoni profile image

Dr. Patrizia Cavazzoni

Boston University

Chief Medical Officer

MD from McGill University

The University of Texas Health Science Center at San Antonio

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486
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Dr. Andrew Masica profile image

Dr. Andrew Masica

The University of Texas Health Science Center at San Antonio

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MD from Indiana University School of Medicine

Dr. Taylor Eighmy profile image

Dr. Taylor Eighmy

The University of Texas Health Science Center at San Antonio

Acting President

PhD in Civil Engineering from the University of New Hampshire

National Development and Research Institutes, Inc.

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38
Recruited
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