Chronic PainNCT04236284
Management of Chronic Pain and PTSD in Gulf War Veterans With tDCS+Prolonged Exposure
A study testing Home-based tDCS and Prolonged Exposure Therapy in people with Chronic Pain and PTSD, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, PTSD
- What is being tested?
- Home-based tDCS and Prolonged Exposure Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 23 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
Read the 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
- Being tested
- Home-based tDCS, Prolonged Exposure Therapy
- Medical subject headings
- Chronic Pain, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based tDCSDevice
Also called Soterix 1x1 tDCS mini-CT Stimulator
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 TherapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Home-based tDCS; Behavioral: Prolonged Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study
Measured: Week 0
Feasibility of Biomarker Collection as Assessed by Number of Planned Saliva Samples Divided by Number of Planned Saliva Samples Collected
Measured: Week 12
Feasibility of Biomarker Viability as Assessed by Percent of Viable Saliva Samples
Measured: Week 12
Feasibility of Retention as Assessed by Number of Participants Who Complete at Least 8 Sessions
Measured: Week 12
Feasibility of Data Collection as Assessed by Percent of Missing Data
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12
Secondary outcomes (21)
PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
PCL-5 score ranges from 0 to 80, with a higher score indicating greater PTSD.
Measured: Week 0
PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
PCL-5 score ranges from 0 to 80, with a higher score indicating greater PTSD.
Measured: Week 6
PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
PCL-5 score ranges from 0 to 80, with a higher score indicating greater PTSD.
Measured: Week 12
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 score ranges from 0 to 27, with a higher score indicating greater depression.
Measured: Week 0
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 score ranges from 0 to 27, with a higher score indicating greater depression.
Measured: Week 6
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 score ranges from 0 to 27, with a higher score indicating greater depression.
Measured: Week 12
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
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
Measured: Week 0
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
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
Measured: Week 6
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
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
Measured: Week 12
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
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.
Measured: Week 0
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
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.
Measured: Week 6
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
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.
Measured: Week 12
Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
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.
Measured: Week 0
Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
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.
Measured: Week 6
Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
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.
Measured: Week 12
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
Total scores ranges from 0 to 52, with a higher score indicating greater Pain Catastrophizing.
Measured: Week 0
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
Total scores ranges from 0 to 52, with a higher score indicating greater Pain Catastrophizing.
Measured: Week 6
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
Total scores ranges from 0 to 52, with a higher score indicating greater Pain Catastrophizing.
Measured: Week 12
Salivary Biomarker Measurement
Salivary levels of the biomarker panel (cortisol, substance P, DHEA, IL-1, and IL-6) using enzyme-linked immunosorbent assays (ELISA).
Measured: Week 0
Salivary Biomarker Measurement
Salivary levels of the biomarker panel (cortisol, substance P, DHEA, IL-1, and IL-6) using enzyme-linked immunosorbent assays (ELISA).
Measured: Week 6
Salivary Biomarker Measurement
Salivary levels of the biomarker panel (cortisol, substance P, DHEA, IL-1, and IL-6) using enzyme-linked immunosorbent assays (ELISA).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start15 Jan 2020
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melba Hernandez-Tejada, PhD, DHA, The University of Texas Health Science Center, Houston
- Investigators
- Melba Hernandez Tejada, PhD, DHA, Principal investigator, UTHealth at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236284
- Sponsor's protocol ID
- HSC-MS-19-0960
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2020
- Last updated
- 3 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35808998
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Chronic Pain and PTSD in Gulf War Veterans With tDCS+Prolonged Exposure
- ClinicalTrials.gov ID
- NCT04236284
- Acronym / sponsor ID
- HSC-MS-19-0960
- Conditions
- Chronic Pain, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Posted 3 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Experimental | Device: Home-based tDCS, Behavioral: Prolonged Exposure TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based tDCSAlso: Soterix 1x1 tDCS mini-CT StimulatortDCS 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. | Device | Home-based tDCS + Prolonged Exposure Therapy |
| Prolonged Exposure TherapyProlonged 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). | Behavioural | Home-based tDCS + Prolonged Exposure Therapy |
Primary outcome
Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study
Time frame: Week 0
Feasibility of Biomarker Collection as Assessed by Number of Planned Saliva Samples Divided by Number of Planned Saliva Samples Collected
Time frame: Week 12
Feasibility of Biomarker Viability as Assessed by Percent of Viable Saliva Samples
Time frame: Week 12
Feasibility of Retention as Assessed by Number of Participants Who Complete at Least 8 Sessions
Time frame: Week 12
Feasibility of Data Collection as Assessed by Percent of Missing Data
Time frame: Week 12
Feasibility as Indicated by Satisfaction as Assessed by the Charleston Psychiatric Outpatient Satisfaction Scale
Time frame: 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
Time frame: 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."
Feasibility as Indicated by Treatment Acceptability as Assessed by an Acceptability Scale
Time frame: 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."
Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
Time frame: Week 0
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 Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
Time frame: Week 6
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 Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
Time frame: 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
Time frame: Week 0
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.
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
Time frame: Week 6
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.
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
Time frame: 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)
Time frame: Week 0
Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.
PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
Time frame: Week 6
Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.
PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
Time frame: Week 12
Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.
21 secondary outcomes
PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
Time frame: Week 0
PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
Time frame: Week 6
PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
Time frame: Week 12
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Week 0
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Week 6
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Week 12
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
Time frame: Week 0
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
Time frame: Week 6
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
Time frame: Week 12
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Time frame: Week 0
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Time frame: Week 6
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Time frame: Week 12
Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
Time frame: Week 0
Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
Time frame: Week 6
Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
Time frame: Week 12
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
Time frame: Week 0
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
Time frame: Week 6
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
Time frame: Week 12
Salivary Biomarker Measurement
Time frame: Week 0
Salivary Biomarker Measurement
Time frame: Week 6
Salivary Biomarker Measurement
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35808998Hernandez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melba Hernandez Tejada, PhD, DHA principal investigator
UTHealth at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based tDCS and Prolonged Exposure Therapy in people with Chronic Pain and PTSD, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study (time frame: Week 0). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.