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
Sponsors and collaborators
The University of Texas Health Science Center, Houston
Lead sponsor
United States Department of Defense
Collaborator