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CLASP-PE arm for Post-Traumatic Stress Disorder
N/A
Waitlist Available
Led By Ronald Acierno, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
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 6 months post treatment
Awards & highlights
Study Summary
This trial is testing a new intervention to prevent blood clots and PE (pulmonary embolism). They hope it is safe, accepted, feasible, and efficacious.
Who is the study for?
This trial is for active duty service members who have PTSD, confirmed by the CAPS scale, and are experiencing suicidal thoughts or have attempted suicide. Participants must be able to communicate in English to consent and complete study tasks. Those with current psychotic/manic episodes, severe substance use disorder, or undergoing certain other PTSD/suicide-focused therapies cannot join.Check my eligibility
What is being tested?
The CLASP-PE arm intervention is being tested for its safety, acceptability, feasibility, and efficacy in reducing PTSD-related distress and suicidal behaviors/thoughts among military personnel. This pilot study aims to gather initial data on the effectiveness of this integrated approach.See study design
What are the potential side effects?
Since this trial involves a psychological intervention rather than medication, traditional side effects like those seen with drugs may not apply. However, participants might experience emotional discomfort or increased distress as they confront traumatic memories during therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Extent to which client was satisfied with the training as assessed by the Client Satisfaction Questionnaire (CSQ)
Feedback form participants as assessed by the Qualitative interview(QI) which will include a series of open ended questions aimed at eliciting feedback from participants about their perspective on the PE-CLASP Intervention
Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
+6 moreSecondary outcome measures
Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
Trial Design
1Treatment groups
Experimental Treatment
Group I: CLASP-PE armExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
909 Previous Clinical Trials
323,741 Total Patients Enrolled
Ronald Acierno, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
326 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The Clinician Administered PTSD Scale (CAPS) will be used to diagnose PTSD for the purpose of this study, which aims to demonstrate a reduction in PTSD-related distress and ultimately in suicidal behaviors and thoughts.You have had thoughts of wanting to harm yourself along with a plan or have attempted suicide in the past.You agree to let the research team communicate with your healthcare providers and mental health professionals to ensure that important information is shared openly.You are currently serving in the military.It is essential that you be able to read and write in English in order to complete the informed consent, self-report questionnaires, and homework assignments for the study.You have had thoughts of hurting or killing yourself and/or have attempted suicide in the past. The study aims to help people who experience these thoughts and behaviors.You are currently struggling with a serious addiction that may affect your ability to focus on reducing symptoms of PTSD and suicidal thoughts.You are currently receiving specific types of therapy for PTSD or suicidal thoughts, such as Prolonged Exposure, Cognitive Processing Therapy, or Coping LongTerm with Active Suicide Program (CLASP).
Research Study Groups:
This trial has the following groups:- Group 1: CLASP-PE arm
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.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04284410 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to participate in this experiment currently?
"Affirmative. The trial listing on clinicaltrials.gov states that the study, which was initially posted in October 2021, is presently searching for participants to join their research team. 15 individuals are necessary from a single site for this investigation."
Answered by AI
How many people are being administered the treatment in this experimental trial?
"Affirmative. Clinicaltrials.gov records indicate that this medical trial is currently receiving applications, which began on October 2nd 2021 and was last updated on the 31st of October 2022. The study requires 15 individuals at a single site to contribute data."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
What site did they apply to?
The University of Texas Health Science Center at Houston
Why did patients apply to this trial?
I am on a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived no prior treatments
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