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

NCT ID: NCT04236284

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2021-11-23

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%)

Conditions

Chronic Pain; PTSD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home-based tDCS + 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.

Group Type: EXPERIMENTAL

Home-based tDCS

Intervention Type: 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.

Prolonged Exposure Therapy

Intervention Type: 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).

Interventions

Home-based tDCS

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.

Intervention Type: DEVICE

Prolonged Exposure Therapy

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Soterix 1x1 tDCS mini-CT Stimulator

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Melba Hernandez-Tejada, PhD, DHA

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melba Hernandez Tejada, PhD, DHA

Role: PRINCIPAL_INVESTIGATOR

UTHealth at Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35808998 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-19-0960

Identifier Type: -

Identifier Source: org_study_id