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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE) | Experimental |
| |
| Sham Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE) | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Device | A 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months |
| 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. | Baseline, post treatment (after session 10) 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melba Hernandez-Tejada, PhD, DHA | Contact | 713 4862729 | Melba.A.HernandezTejada@uth.tmc.edu | |
| Stephanie Hart | Contact | 843-577-5011 x205103 | 205103 | zeigls@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melba Hernandez-Tejada, PhD, DHA | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charleston VA Healthcare System | Recruiting | Charleston | South Carolina | 29401-5799 | United States |
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| Massed-Prolonged Exposure (PE) | Behavioral | PE 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) | Device | Sham tDCS delivers an active stimulation of 2 Ma electrical current) for a few seconds to mimic the sensations of active tDCS |
|
| 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. | Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months |
| 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 | Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months |
| 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. | Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months |
| Change in anxiety as assessed by the Generalized Anxiety Disorder Scale 7 (GAD-7) | This is a 7 item questionnaire , each scored from 0( not at all) to 3(nearly every day) for a maximum score range of 0-21 higher scores indicating more anxiety | Baseline,post treatment (after session 10) 3 months, 6 months |
| Quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a 19-item self-report questionnaire. There are 7 component scores (subjective sleep quality, sleep latency, duration, efficiency, disturbances, medication use, daytime dysfunction) and each is scored from 0 (No difficulty or very good sleep) to 3 ( Severe difficulty) for a score range of 0-21 higher score indicating poor sleep | Baseline, post treatment (after session 10) 3 months, 6 months |
| Change in depression as assessed by the The Patient Health Questionnaire (PHQ-9) | This is a 9 item questionnaire and each is scored on a 4 point likert scale from 0(not at all) to 3(nearly every day) for a score range of 0-27 higher scores indicating worse outcome | Baseline, post treatment (after session 10) 3 months, 6 months |
| The University of Texas Health Science Center at Houston | Active, not recruiting | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D013313 | Stress Disorders, Post-Traumatic |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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