Management of Chronic Pain and PTSD in Gulf War Veterans With tDCS+Prolonged Exposure

Not Applicable

Completed

Conditions: Chronic Pain
PTSD

Interventions: Device: Home-based tDCS
Behavioral: Prolonged Exposure Therapy

Registration Number: NCT04236284

Lead Sponsor: The University of Texas Health Science Center, Houston

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%)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home-based tDCS + Prolonged Exposure Therapy	Home-based tDCS	Participants will come in person to the clinic office to complete the baseline visit and the in-person training for the use of both home-based self-administered tDCS and the home-based telehealth device (iPad) for the PE sessions. They understand that they will start the sessions of tDCS once they start the in vivo and imaginal exposures assignments at home. They will self-administer (under televideo supervision) the tDCS session before doing in vivo and/or imaginal exposures assignments. The participants will be remotely supervised by trained research staff at each stimulation to ensure the technique is correct and to monitor any adverse events. We will provide secure videoconferencing software (e.g., WebEx) and ensure the participants are comfortable using the telehealth software.
Home-based tDCS + Prolonged Exposure Therapy	Prolonged Exposure Therapy	Participants will come in person to the clinic office to complete the baseline visit and the in-person training for the use of both home-based self-administered tDCS and the home-based telehealth device (iPad) for the PE sessions. They understand that they will start the sessions of tDCS once they start the in vivo and imaginal exposures assignments at home. They will self-administer (under televideo supervision) the tDCS session before doing in vivo and/or imaginal exposures assignments. The participants will be remotely supervised by trained research staff at each stimulation to ensure the technique is correct and to monitor any adverse events. We will provide secure videoconferencing software (e.g., WebEx) and ensure the participants are comfortable using the telehealth software.

Primary Outcome Measures

Name	Time	Method
Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study	Week 0
Feasibility of Data Collection as Assessed by Percent of Missing Data	Week 12
Feasibility as Indicated by Treatment Acceptability as Assessed by an Acceptability Scale	Week 12	Treatment acceptability will be assessed by a scale, with a total score ranging from 0 to 10, with 0 being "not acceptable, this treatment should not be offered to veterans, those in pain, or those with PTSD" to 10 being "completely acceptable, this treatment is perfectly suited to veterans and others with pain and PTSD symptoms."
Feasibility of Biomarker Collection as Assessed by Number of Planned Saliva Samples Divided by Number of Planned Saliva Samples Collected	Week 12
Feasibility of Biomarker Viability as Assessed by Percent of Viable Saliva Samples	Week 12
Feasibility of Retention as Assessed by Number of Participants Who Complete at Least 8 Sessions	Week 12
Feasibility as Indicated by Satisfaction as Assessed by the Charleston Psychiatric Outpatient Satisfaction Scale	Week 12	The Charleston Psychiatric Outpatient Satisfaction Scale total score ranges from 13 to 65, with a higher score indicating higher satisfaction.
Feasibility as Indicated by Treatment Credibility as Assessed by a Credibility Scale	Week 12	Treatment credibility will be assessed by a scale, with a total score ranging from 0 to 10, with 0 being "not credible, I did not think this treatment would help either my PTSD or Pain symptoms" to 10 being "completely credible, I was very sure this treatment would help both my PTSD and Pain symptoms."
Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale	Week 12	PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days. The measure includes 8-items rating pain from "Not at all" = 1 to "Very much" = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference.
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale	Week 12	PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Raw scores are reported.
PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)	Week 12	Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.

Secondary Outcome Measures

Name	Time	Method
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)	Week 12	There are 4 domains on the WHOQOL-BREF, listed below, and for all domains a higher score indicates a greater quality of life. * physical health domain (7 items) - total score ranges from 7 to 35 * psychological health domain (6 items) - total score ranges from 6 to 30 * social relationships domain (3 items) 3 - total score ranges from 3 to 15 * environmental health domain (8 items) - total score ranges 8 to 40
PTSD as Assessed by the PTSD Checklist-5 (PCL-5)	Week 12	PCL-5 score ranges from 0 to 80, with a higher score indicating greater PTSD.
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)	Week 12	There are 13 subscales of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI), with each subscale ranging in score from 0 to 6, with a higher score indicating a greater degree of the domain assessed by the subscale.
Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)	Week 12	Total score ranges from 17 - 68. A score of 17 is the lowest possible score, and indicates no kinesiophobia (that is, fear of pain with movement) or negligible kinesiophobia. A score of 68 is the highest possible score and indicates extreme kinesiophobia.
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)	Week 12	Total scores ranges from 0 to 52, with a higher score indicating greater Pain Catastrophizing.
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)	Week 12	The PHQ-9 score ranges from 0 to 27, with a higher score indicating greater depression.
Salivary Biomarker Measurement	Week 12	Salivary levels of the biomarker panel (cortisol, substance P, DHEA, IL-1, and IL-6) using enzyme-linked immunosorbent assays (ELISA).