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Behavioural Intervention
Integrated Therapies for PTSD
N/A
Recruiting
Research Sponsored by Palo Alto Veterans Institute for Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline through 3 months post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial will test an intervention integrating three therapies to reduce symptoms in firefighters with PTSD, insomnia, and nightmares. 50 participants will be randomized to immediate or delayed treatment to assess efficacy.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Since the interventions are non-medical cognitive behavioral therapies focusing on exposure therapy and coping strategies for sleep-related issues there may be minimal side effects. However some participants might experience temporary increases in distress due to confronting traumatic memories.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline through 3 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline through 3 months post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinician Administered PTSD Scale (CAPS-5)
Insomnia Severity Index (ISI)
Nightmare Disorders Index
+2 moreSecondary study objectives
Depressive Symptoms Index-Suicidality Subscale (DSI-SS)
Net Prompter Score
Patient Health Questionnaire-9 (PHQ-9)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Written Exposure Therapy (WET)
2023
N/A
~30
Cognitive Behavioral Therapy for Insomnia (CBTi)
2016
N/A
~170
Find a Location
Who is running the clinical trial?
Palo Alto Veterans Institute for ResearchLead Sponsor
56 Previous Clinical Trials
8,576 Total Patients Enrolled
University of ArizonaOTHER
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159,680 Total Patients Enrolled
Oregon State UniversityOTHER
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8,384 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I have significant PTSD symptoms, including frequent flashbacks and avoiding reminders of the trauma.I have severe trouble sleeping.I experience nightmares at least once a month.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate Intervention
- Group 2: Delayed Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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