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

NCT04236284 | Completed Results FDA Device

• 1 other identifier: HSC-MS-19-0960
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; PTSD

Outcome Measures

Primary Outcomes (17)

• Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study

  Week 0

• 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 of Data Collection as Assessed by Percent of Missing Data

  Week 12

• Feasibility as Indicated by Satisfaction as Assessed by the Charleston Psychiatric Outpatient Satisfaction Scale

  The Charleston Psychiatric Outpatient Satisfaction Scale total score ranges from 13 to 65, with a higher score indicating higher satisfaction.

  Week 12

• Feasibility as Indicated by Treatment Credibility as Assessed by a Credibility Scale

  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."

  Week 12

• Feasibility as Indicated by Treatment Acceptability as Assessed by an Acceptability Scale

  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."

  Week 12

• Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale

  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.

  Week 0

• Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale

  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.

  Week 6

• Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale

  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.

  Week 12

• Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale

  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.

  Week 0

• Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale

  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.

  Week 6

• Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale

  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.

  Week 12

• PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)

  Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.

  Week 0

• PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)

  Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.

  Week 6

• PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)

  Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.

  Week 12

Secondary Outcomes (21)

• PTSD as Assessed by the PTSD Checklist-5 (PCL-5)

  Week 0

• PTSD as Assessed by the PTSD Checklist-5 (PCL-5)

  Week 6

• PTSD as Assessed by the PTSD Checklist-5 (PCL-5)

  Week 12

• Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)

  Week 0

• Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)

  Week 6

Study Arms (1)

Home-based tDCS + Prolonged Exposure Therapy

EXPERIMENTAL

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.

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

Interventions

Home-based tDCS DEVICE

tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.

Also known as: Soterix 1x1 tDCS mini-CT Stimulator

Home-based tDCS + Prolonged Exposure Therapy

Prolonged Exposure Therapy BEHAVIORAL

Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education 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 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).

Home-based tDCS + Prolonged Exposure Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Hernandez-Tejada MA, Cherry KE, Rauch SAM, Acierno R, Fries GR, Muzzy W, Teng EJ, Wangelin B, Ahn H. Management of Chronic Pain and PTSD in Veterans With tDCS+Prolonged Exposure: A Pilot Study. Mil Med. 2023 Nov 3;188(11-12):3316-3321. doi: 10.1093/milmed/usac200.

  PMID: 35808998 DERIVED

MeSH Terms

Conditions

Chronic Pain; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Melba Hernandez Tejada, PhD, DHA
• Organization: The University of Texas Health Science Center at Houston

Melba.A.HernandezTejada@uth.tmc.edu

7134862729

Study Officials

• Melba Hernandez Tejada, PhD, DHA

  UTHealth at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 22, 2020
• Study Start: January 15, 2020
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: February 3, 2023
• Results First Posted: February 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)