Impact of Cognitive Behavioral Therapy on PTSD-CVD Link

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06429293
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive processing therapy — BEHAVIORAL
    The active intervention is Cognitive Processing Therapy (CPT) is a gold-standard cognitive behavioral therapy for PTSD. The CPT intervention consists of 12 60-minute sessions teaching skills to challenge trauma-relevant cognitions that are distorted or unhelpful. Trauma-relevant cognitions fall into five themes that are highlighted during treatment: safety, trust, power/control, esteem, and intimacy. The empirical base for CPT is strong with numerous studies demonstrating that it results in significant reduction of PTSD symptoms regardless of trauma type and that it is 89% more effective than control treatment. CPT has been successfully implemented in virtual formats with comparable efficacy levels to that of in-person CPT. CPT sessions for this study will be conducted virtually by a CPT-trained clinician

Study Details

This is a pilot randomized controlled trial to assess the impact of a first-line treatment for posttraumatic stress disorder (PTSD) (Cognitive Processing Therapy; CPT) versus waitlist control on mechanisms of cardiovascular disease (CVD) risk. Further, this study will test the hypothesis that CPT reduces CVD risk through its effects on inflammation and autonomic function and that these changes are driven by changes in stress-related neural activity (SNA)

Key Dates

Start date
Jul 1, 2023
Status verified
Sep 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitive processing therapy
    12 week treatment period of cognitive processing therapy followed by a post-treatment visit.
  • No Intervention: Control waitlist
    Participants randomized to waitlist are offered CPT upon completion of the post-treatment visit.

Primary Outcome Measure

Arterial inflammation [ Time Frame: Baseline and 12-weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Michael Osborne, MD
[email protected]

Find similar trials in Boston, MA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Massachusetts General Hospital· Boston, MA

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