Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Integrated Treatment for Pain and PTSD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to examine comparative effectiveness of two home-based telemedicine delivered interventions: transcranial Direct Current Stimulation (tDCS) combined with Massed Prolonged Exposure (Massed-PE) vs. Sham tDCS combined with Massed PE, focusing on pain and PTSD outcomes, to determine the comparative effectiveness of the two interventions on process outcomes of patient satisfaction, treatment attrition, and treatment compliance and to explore changes in blood biomarkers associated with stress and inflammatory processes related to pain and PTSD symptom improvements following treatment.

Eligibility criteria

Qualifiers

Presence of musculoskeletal, chronic, non-cancer pain with a rating of ≥ 3 out of 10 on a 0-10 on the Defense and Veterans Pain Rating Scale (DVPRS) and a pain intensity and interference score of 1 standard deviation above PROMIS normative data (see Measures section below). Symptoms will be required to be of at least six months duration and verified diagnosis in their medical chart authorized by informed consent

Diagnosis of PTSD assigned on the basis of the Clinician Administered PTSD Scale (CAPS-5) and PCL-5 ≥ 30

willing to participate in study randomization, treatment assignment, and assessments.

Disqualifiers

Having a household member who is already enrolled in the study

Active psychosis or dementia at screening

Suicidal ideation with clear intent

Current substance dependence

Trial design

Treatments tested in this trial

  • Transcranial Direct Current Stimulation (tDCS)
  • Massed-Prolonged Exposure (PE)
  • Sham Transcranial Direct Current Stimulation (tDCS)

Treatment groups

146 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The University of Texas Health Science Center, Houston

Lead sponsor

United States Department of Defense

Collaborator