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.
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.
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
Parallel
Transcranial Direct Current Stimulation (tDCS)
DeviceA constant current intensity of 2 Ma electrical current will be administered for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday)using the headgear M1-SO montage placement.
Massed-Prolonged Exposure (PE)
BehavioralPE will include a) psychoeducation about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 10), c) repeated, prolonged, imaginal exposure to traumatic memories (sessions 3 through 10). All sessions will be delivered via telehealth.
Sham Transcranial Direct Current Stimulation (tDCS)
DeviceSham tDCS delivers an active stimulation of 2 Ma electrical current) for a few seconds to mimic the sensations of active tDCS
Change in pain intensity as measured by the Defense and Veterans Pain Rating Scale (DVPRS)
The DVPRS is a validated 11-point numeric rating scale and is scored from 0(no pain at all) to 10(worst pain ever possible), higher scores indicate greater pain severity.
Change in PTSD symptoms as assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
The CAPS-5 is a 30-item structured clinical interview used to assess the presence and severity of Posttraumatic Stress Disorder (PTSD) symptoms according to Diagnostic and Statistical Manual of Mental Disorders(DSM-5)diagnostic criteria. The scale includes 20 core PTSD symptom items rated on a 5-point scale (0-4) for both frequency and intensity. Each item receives a severity score ranging from 0 (absent) to 4 (extreme/incapacitating), for a total score range of 0 to 80. Higher scores indicate greater PTSD symptom severity.
Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
This is a 3 item questionnaire and each is scored from 1 (no pain) to 5 (very severe) , maximum score of 15. Higher score indicates greater pain intensity
Change in pain interference as assessed by the PROMIS Pain 8a Interference Scale
This is a 8 item questionnaire scored from 1 (not at all) to 5 (very much) , raw score range is 8-40, higher scores indicating greater pain interference.
Change in symptoms of Post-Traumatic Stress Disorder (PTSD)as assessed by the PTSD Checklist-5 Civilian (PCL-5)
This is a 20 item questionnaire each scored from 0(not at all) to 4( extremely), for a total score range of 0-80 higher scores indicating worse outcome
Change in Quality of life as assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
This is a 26-item measure categorized into four domains (i.e., physical health, psychological well- being, social relationships, and environment).Each item is rated on a 5-point Likert scale ranging from 1 (low perception) to 5 (high perception). Domain scores are calculated and transformed to a 0-100 scale, with higher scores indicating better perceived quality of life. Two additional items assess overall quality of life and general health.
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center, Houston
Lead sponsor
United States Department of Defense
Collaborator
