Clinical trial NCT04236284: Management of Chronic Pain and PTSD in Gulf War Veterans With tDCS+Prolonged Exposure
Official title: Management of Chronic Pain and PTSD in Gulf War Veterans With tDCS+Prolonged Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
PTSD
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gulf War Veterans (a DoD/VA defined service era corresponding to the first Gulf War under operations Desert Storm and Desert Shield 1990-1991), especially those who present with Post-Traumatic Stress Disorder (PTSD), are particularly likely to experience chronic pain. Veterans with co-morbid chronic pain and PTSD utilize healthcare services at a higher rate than those with pain or PTSD alone. Unfortunately, there are no integrated treatments for Pain and PTSD. Moreover, non-pharmacological treatments for pain such as Cognitive Behavioral Therapy are useful in only about 50% of cases. Transcranial direct current stimulation (tDCS) may be an effective treatment for pain, and has been recently used to ameliorate PTSD symptoms. Prolonged Exposure Therapy (PE) is highly effective in treating PTSD symptoms. Therefore, we propose to (a) integrate \& (b) gather feasibility data for home-based tDCS + PE for Pain and PTSD with 15 Gulf War Veterans.

The Overall Aim of the present proposal is to integrate, refine and investigate the feasibility (e.g., pilot testing, recruitment, attrition, assessment) of tDCS for treating chronic pain with a best practices evidence-based treatment for PTSD (i.e., Prolonged Exposure: PE) in 15 Gulf War veterans, a group for which both pain (fibromyalgia) and PTSD are particularly problematic.

Detailed description: Chronic pain is one of the most prevalent health conditions among Americans, affecting about a third of the general population. In Gulf War (1990-1991) veterans, chronic pain is even more common, with a prevalence of about 50%. Indeed, the pain-related fibromyalgia diagnosis is part of Gulf War Syndrome and is highly comorbid with other common military service-related health problems such as Posttraumatic Stress Disorder (PTSD). Moreover, lack of effective, integrated, and available alternative treatments for chronic pain contributes to the opioid epidemic.

PTSD is also highly prevalent in Gulf War Veterans, at about 15-25% of Operation Desert Shield and Desert Storm Veterans. Moreover, several investigators note that PTSD treatment response is poorer for Veterans who experience chronic pain and for Veterans who served in the Gulf War.

The Overall Aim of the present proposal is to integrate, refine and investigate the feasibility (e.g., pilot testing, recruitment, attrition, assessment) of tDCS for treating chronic pain with a best practices evidence-based treatment for PTSD (i.e., Prolonged Exposure: PE) in 15 Gulf War veterans, a group for which both pain (fibromyalgia) and PTSD are particularly problematic.

SA1: Integrate the home-based tDCS+PE Treatment. The investigative team is comprised of Pain, PTSD, and salivary biomarker experts who will integrate tDCS into the 12 session PE treatment protocol.

H1: The 12 session PE protocol will yield itself well to tDCS component integration based on participant feedback.

SA2: Test the feasibility of both the integrated intervention and key study design features, including translational research features such as biomarker assessment in a non-randomized trial with 15 Gulf War Veterans assessed at baseline and post-treatment. Feasibility of the home-based tDCS+PE intervention will be measured in terms of recruitment metrics, assessment burden, successful biomarker collection, specification of biomarker relationship to hypothesized mechanisms of change, treatment attrition, rates of missing data at each measurement time point, participant satisfaction, and ratings of treatment face validity. Post treatment key informant interviews will be conducted where suggestions for treatment enhancement and satisfaction will be systematically collected and analyzed.

H2 is given in terms of Specific Pre-Defined Milestones for Success, including: 75% of Veterans experiencing chronic pain (fibromyalgia) and PTSD who enroll will complete at least 8 sessions of the integrated treatment, and both completers and dropouts will offer actionable suggestions in exit interviews for improving the delivery of the intervention. SA2) Feasibility metrics will be acceptable for recruitment rate (two per month), treatment completion of 8 sessions (75%), assessment completion (90%), and good to excellent satisfaction (95%)

Eligibility criteria: Inclusion Criteria:

* Presence of chronic non-cancer pain and pain interference, defined as scoring 1 standard deviation above PROMIS normative data on both the 3-item PROMIS Pain Intensity 3a scal and the 8-item PROMIS Pain 8a Interference scale. Symptoms will be required to be of six-month duration or longer
* Diagnosis of PTSD assigned on the basis of the Clinician Administered PTSD Scale.

Exclusion Criteria:

* 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
* current opioid medication for pain.

Primary outcomes:
measure: Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study
timeFrame: Week 0
measure: Feasibility of Biomarker Collection as Assessed by Number of Planned Saliva Samples Divided by Number of Planned Saliva Samples Collected
timeFrame: Week 12
measure: Feasibility of Biomarker Viability as Assessed by Percent of Viable Saliva Samples
timeFrame: Week 12
measure: Feasibility of Retention as Assessed by Number of Participants Who Complete at Least 8 Sessions
timeFrame: Week 12
measure: Feasibility of Data Collection as Assessed by Percent of Missing Data
timeFrame: Week 12
measure: Feasibility as Indicated by Satisfaction as Assessed by the Charleston Psychiatric Outpatient Satisfaction Scale
timeFrame: Week 12
measure: Feasibility as Indicated by Treatment Credibility as Assessed by a Credibility Scale
timeFrame: Week 12
measure: Feasibility as Indicated by Treatment Acceptability as Assessed by an Acceptability Scale
timeFrame: Week 12
measure: Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
timeFrame: Week 0
measure: Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
timeFrame: Week 6
measure: Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
timeFrame: Week 12
measure: Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
timeFrame: Week 0
measure: Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
timeFrame: Week 6
measure: Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
timeFrame: Week 12
measure: PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
timeFrame: Week 0
measure: PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
timeFrame: Week 6
measure: PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
timeFrame: Week 12
Secondary outcomes:
measure: PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
timeFrame: Week 0
measure: PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
timeFrame: Week 6
measure: PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
timeFrame: Week 12
measure: Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Week 0
measure: Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Week 6
measure: Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Week 12
measure: Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
timeFrame: Week 0
measure: Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
timeFrame: Week 6
measure: Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
timeFrame: Week 12
measure: Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
timeFrame: Week 0
measure: Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
timeFrame: Week 6
measure: Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
timeFrame: Week 12
measure: Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
timeFrame: Week 0
measure: Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
timeFrame: Week 6
measure: Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
timeFrame: Week 12
measure: Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: Week 0
measure: Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: Week 6
measure: Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: Week 12
measure: Salivary Biomarker Measurement
timeFrame: Week 0
measure: Salivary Biomarker Measurement
timeFrame: Week 6
measure: Salivary Biomarker Measurement
timeFrame: Week 12
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: UTHealth at Houston
name: Melba Hernandez Tejada, PhD, DHA
role: PRINCIPAL_INVESTIGATOR
References: