rTMS-augmented Written Exposure Therapy for PTSD

Part of paid clinical trials in Temple, Texas.

Sponsor
VA Office of Research and Development
Study ID
NCT05149534
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Written Exposure Therapy — BEHAVIORAL
    Narrative written disclosure of trauma administered in an evidence-based protocol.
  • repetitive transcranial magnetic stimulation — DEVICE
    Noninvasive magnetic neuromodulation device

Study Details

Post-traumatic stress disorder (PTSD) is prevalent and represents a high healthcare burden among Veterans. Repetitive transcranial magnetic stimulation (rTMS) is a brain-based therapy that may be effective for treating PTSD. The theorized mechanism of rTMS is enhancement of emotional flexibility via the dorsolateral prefrontal cortex node of the brain's cognitive control network. Given this mechanism of action, adding rTMS to an evidence-based psychotherapy (EBP) for PTSD may enhance treatment effects. Written exposure therapy (WET) is a brief EBP for PTSD found to reduce attrition compared to lengthier first line treatments. In this study, the investigators will determine if active rTMS added to WET compared with sham rTMS added to WET results in improved PTSD outcomes. The investigators will also determine if emotional flexibility is a mechanism of symptom improvement. This work will improve upon PTSD intervention and inform the mechanism of treatment effectiveness for Veterans suffering from PTSD.

Key Dates

Start date
Jan 3, 2022
Status verified
Jan 2026
Primary completion
Jan 29, 2027
Completion
Jan 29, 2027

Study Design

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

Arms

  • Experimental: Active TMS/WET
    Active repetitive transcranial magnetic stimulation completed prior to written exposure therapy
  • Sham Comparator: Sham TMS/WET
    Sham repetitive transcranial magnetic stimulation completed prior to written exposure therapy

Primary Outcome Measure

Change in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Pre intervention (Baseline), post-intervention (Treatment Session 5), and following the conclusion of the intervention, up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Central Texas Veterans Health Care System, Temple, TXTempleTexas76504-7451
Joseph F Maher
[email protected]
254-743-1478
David E Dostal, PhD MA BS
[email protected]
(254) 743-2464
Crystal M Lantrip (PRINCIPAL_INVESTIGATOR)

Find similar trials in Temple, TX

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Central Texas Veterans Health Care System, Temple, TX· Temple, TX

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