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Behavioral Intervention

Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder

N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Criterion A trauma exposure and PTSD symptoms (clinically significant symptoms in at least two symptom clusters)
Subclinical atherosclerotic CVD, clinical atherosclerotic CVD, or increased risk for atherosclerotic CVD
Must not have
History of stroke, brain surgery, seizure
Use of certain CVD medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12-weeks
Awards & highlights

Summary

This trial aims to study the effects of a PTSD treatment called Cognitive Processing Therapy (CPT) on cardiovascular disease risk factors. It will compare the impact of CPT versus no treatment on inflammation and aut

Who is the study for?
This trial is for individuals with PTSD to see if Cognitive Processing Therapy (CPT) can lower their risk of heart disease. Participants should be diagnosed with PTSD but not currently receiving CPT. There's no mention of specific exclusions, so general health requirements likely apply.
What is being tested?
The study tests whether CPT, a common treatment for PTSD, can reduce the risk of cardiovascular disease by affecting inflammation and autonomic function, potentially influenced by stress-related neural activity.
What are the potential side effects?
Cognitive Behavioral Therapies like CPT are generally low-risk but may include temporary increases in distress, emotional discomfort, and heightened awareness of negative thoughts or feelings during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have experienced a traumatic event and suffer from PTSD symptoms.
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I have or am at high risk for heart artery disease.
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of stroke, brain surgery, or seizures.
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I am taking medication for heart or blood vessel conditions.
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I have a neurological or systemic inflammatory disease and am on anti-inflammatory treatment.
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I am currently receiving therapy for PTSD.
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I am currently experiencing mania or psychosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Arterial inflammation
Heart rate variability
Secondary outcome measures
Axonal integrity of resting neural connections between brain centers using MRI
Blood pressure
Heart rate
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive processing therapyExperimental Treatment1 Intervention
12 week treatment period of cognitive processing therapy followed by a post-treatment visit.
Group II: Control waitlistActive Control1 Intervention
Participants randomized to waitlist are offered CPT upon completion of the post-treatment visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive processing therapy
2016
Completed Phase 1
~150

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,691 Total Patients Enrolled
American Heart AssociationOTHER
343 Previous Clinical Trials
4,971,568 Total Patients Enrolled
~17 spots leftby Jul 2026
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