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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline through 3 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinician Administered PTSD Scale (CAPS-5)

Insomnia Severity Index (ISI)

Nightmare Disorders Index

+2 more

Secondary outcome measures

Depressive Symptoms Index-Suicidality Subscale (DSI-SS)

Net Prompter Score

Patient Health Questionnaire-9 (PHQ-9)

+3 more

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

Cognitive Behavioral Therapy for Insomnia (CBTi)

2016

N/A

~170

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Palo Alto Veterans Institute for ResearchLead Sponsor

52 Previous Clinical Trials

7,855 Total Patients Enrolled

University of ArizonaOTHER

515 Previous Clinical Trials

148,664 Total Patients Enrolled

Oregon State UniversityOTHER

50 Previous Clinical Trials

8,391 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy for Insomnia (CBTi) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05950035 — N/A

Post-Traumatic Stress Disorder Research Study Groups: Immediate Intervention, Delayed Intervention

Post-Traumatic Stress Disorder Clinical Trial 2023: Cognitive Behavioral Therapy for Insomnia (CBTi) Highlights & Side Effects. Trial Name: NCT05950035 — N/A

Cognitive Behavioral Therapy for Insomnia (CBTi) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05950035 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met to become eligible for participation in this research initiative?

"To join this clinical trial, individuals aged 18-65 who suffer from post-traumatic stress disorder are encouraged to apply. This study is currently searching for approximately 50 volunteers."

Answered by AI

What outcomes is this experimental research trying to demonstrate?

"This clinical trial will evaluate the impact of its treatment over a four week period using structured interviews, self-assessments, sleep logs and PHQ-9 questionnaires. The primary outcome is Structured Clinical Interview for DSM-5 Sleep Disorders - Revised (SCISD-R), while secondary outcomes include Self Assessment of Sleep (SASS), Patient Health Questionnaire 9 (PHQ-9) and Sleep Diary & Nightmare Logs."

Answered by AI

Are participants aged 30 or over eligible for this research endeavor?

"According to the trial's inclusion criteria, only those aged 18-65 are eligible. Additionally, there exists 58 trials for minors and 424 studies available for senior citizens."

Answered by AI

Are participants still welcome to join this experiment?

"As stated on clinicaltrials.gov, the recruitment window for this trial has closed; it was initially posted on July 18th 2023 and last updated July 14th 2023. Although not recruiting subjects at present, there are 541 other trials actively enrolling individuals currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Efficient Treatment for Posttraumatic Injury for Firefighters

Carmen McLean 2023. "An Efficient Treatment for Posttraumatic Injury for Firefighters". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05950035.

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