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The primary objective of this study is to evaluate the effects of cognitive-behavioral therapy in combination with transcranial direct current stimulation in (1) improving pain and functionality, (2) reducing severity of opioid use disorders, and (3) reducing impairment in associated mental health areas (e.g., depression, anxiety, PTSD, sleep). The investigators will also determine the effects of treatment on neural activity in cognitive and limbic brain regions involved in pain regulation using functional magnetic resonance imaging (fMRI), and examine its relationship to opioid use severity.
As a result of sustained operations in Afghanistan and Iraq, an increasing number of U.S. military personnel and Veterans are in need of effective pain management treatment. Chronic low back pain (CLBP) is the most common pain condition among returning Veterans and is associated with high levels of opioid analgesic prescribing in VA clinics. Although opioids are effective for acute pain, they are not very effective as a long-term treatment strategy. Furthermore, opioids are associated with significantly increased risk of misuse, addiction, diversion, overdose and death. Consequently, there is a critical need for the development of alternative, effective treatments for CLBP that can be implemented in VA-based healthcare settings. The proposed study will answer critical questions regarding the ability of Transcranial Direct Current Stimulation (tDCS) to augment the effects of cognitive behavioral therapy (CBT) for pain, and elucidate possible mechanisms underlying improved outcomes. tDCS is inexpensive and highly portable, making it a very scalable tool to add to current CBT interventions within the VA healthcare system. This study has the particular advantages of building directly on positive preliminary findings among civilians and is being led by a multi-disciplinary team of experts who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation. The primary objective of the proposed Stage II study is to evaluate the effects of CBT in combination with tDCS in (1) improving pain and functionality, (2) reducing severity of opioid use disorders, and (3) reducing impairment in associated mental health areas (e.g., depression, anxiety, PTSD, sleep). The investigators will also determine the effects of treatment on neural activity in cognitive and limbic brain regions involved in pain regulation using functional magnetic resonance imaging (fMRI), and examine its relationship to opioid use severity. Secondary objectives are to evaluate acute lab-based pain markers and neural correlates of improvement in chronic pain using quantitative sensory testing. In order to accomplish this the investigators are: using a manualized, evidence-based CBT intervention that is already widely-disseminated within the VA system; employing a randomized, between-groups, double-blind experimental design; and examining standardized, repeated, dependent measures of change in: (a) clinical outcomes such as pain, opioid and other substance use disorders (e.g., alcohol, illicit drugs, other prescription drugs), depression, anxiety, sleep and PTSD symptomatology; and (b) process variables such as participant satisfaction, quality of life and treatment retention. The results of this study will provide important information regarding two non-pharmacologic, evidence-based interventions (CBT and tDCS), and will help inform policies and programs to better serve the needs of U.S. military personnel, Veterans, and their families. The findings from this study may help reduce public health costs and morbidity/mortality associated with chronic pain and co-morbid prescription opiate use disorders among our nation's Veterans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS | Experimental | Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current |
|
| tDCS (sham) | Sham Comparator | Inactive (sham) Transcranial Direct Current Stimulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Pain | Behavioral | Cognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Pain | Average daily pain defined by item #5 on the Brief Pain Inventory (BPI). Scale on scale of 0-10; anchored with "0-no pain" and "10- pain as bad as you can imagine." | 3 months |
| Pain Interference | Pain interference defined by the mean of items 9.a ---9.i; the measure is scored on a scale of 0--10, anchored by "0-does not interfere" and "10- completely interferes" | 3 months |
| Pain Catastrophizing | Pain catastrophizing defined by total score of 13 items pain catastrophizing scale. This measure has a total score range of 0-52 where for each item is anchored by "0-not at all" and "4-all the time." Larger total score indicates more catastrophizing. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Misuse | Current Opioid Misuse Measure scores. 17-item Likert-type scale (For each opioid misuse risk behavior item, 0="Never and 4="Very often"). Possible range is 0 to 68. Higher scores indicate more opioid misuse concerns. | 3 months |
| Psychiatric Functioning (Depression) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey J Borckardt, Ph.D. | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | tDCS (Active) | Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current Cognitive Behavioral Therapy for Pain: Cognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities. Transcranial Direct Current Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2020 |
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| Transcranial Direct Current Stimulation | Device | Electrical stimulation of the prefrontal cortex using 2mA of direct current |
|
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| Sham Transcranial Direct Current Stimulation | Device | Sham stimulation of the left dorsolateral prefrontal cortex |
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Depression: Beck Depression Inventory-II (BDI-II): The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Possible range is 0 to 63 points. Higher scores mean more depression symptoms. |
| 3 months |
| Psychiatric Functioning (Anxiety) | Beck Anxiety Inventory (BAI): 21-item self-report inventory used to assess anxiety levels in adults and adolescents. The score range is 0-63. Higher scores mean more anxiety symptoms. | 3 Months |
| Psychiatric Functioning (PTSD) | PTSD Checklist (PCL) 20-item self-report measure of the DSM-5 symptoms of PTSD: Score range: 0-80. Higher scores mean more post-traumatic stress symptoms. | 3 Months |
| Psychiatric Functioning (Sleep) | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated. questionnaire which assesses sleep quality and disturbances. Range of scores: 0-21. Higher scores mean more sleep disturbance. | 3 Months |
| FG001 | tDCS (Sham) | Inactive (sham) Transcranial Direct Current Stimulation Cognitive Behavioral Therapy for Pain: Cognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities. Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex |
| COMPLETED | completed defined as followed up to 3 months |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | tDCS | Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current Cognitive Behavioral Therapy for Pain: Cognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities. Transcranial Direct Current Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current |
| BG001 | tDCS (Sham) | Inactive (sham) Transcranial Direct Current Stimulation Cognitive Behavioral Therapy for Pain: Cognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities. Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Daily Pain | Average daily pain defined by item #5 on the Brief Pain Inventory (BPI). Scale on scale of 0-10; anchored with "0-no pain" and "10- pain as bad as you can imagine." | Posted | Mean | Standard Error | score on a scale | 3 months |
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| |||||||||||||||||||||||||||||
| Primary | Pain Interference | Pain interference defined by the mean of items 9.a ---9.i; the measure is scored on a scale of 0--10, anchored by "0-does not interfere" and "10- completely interferes" | Posted | Mean | Standard Error | score on a scale | 3 months |
| |||||||||||||||||||||||||||||||
| Primary | Pain Catastrophizing | Pain catastrophizing defined by total score of 13 items pain catastrophizing scale. This measure has a total score range of 0-52 where for each item is anchored by "0-not at all" and "4-all the time." Larger total score indicates more catastrophizing. | Posted | Mean | Standard Error | score on a scale | 3 months |
| |||||||||||||||||||||||||||||||
| Secondary | Opioid Misuse | Current Opioid Misuse Measure scores. 17-item Likert-type scale (For each opioid misuse risk behavior item, 0="Never and 4="Very often"). Possible range is 0 to 68. Higher scores indicate more opioid misuse concerns. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
| |||||||||||||||||||||||||||||||
| Secondary | Psychiatric Functioning (Depression) | Depression: Beck Depression Inventory-II (BDI-II): The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Possible range is 0 to 63 points. Higher scores mean more depression symptoms. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
| |||||||||||||||||||||||||||||||
| Secondary | Psychiatric Functioning (Anxiety) | Beck Anxiety Inventory (BAI): 21-item self-report inventory used to assess anxiety levels in adults and adolescents. The score range is 0-63. Higher scores mean more anxiety symptoms. | Posted | Mean | Standard Deviation | score on a scale | 3 Months |
| |||||||||||||||||||||||||||||||
| Secondary | Psychiatric Functioning (PTSD) | PTSD Checklist (PCL) 20-item self-report measure of the DSM-5 symptoms of PTSD: Score range: 0-80. Higher scores mean more post-traumatic stress symptoms. | Posted | Mean | Standard Deviation | score on a scale | 3 Months |
| |||||||||||||||||||||||||||||||
| Secondary | Psychiatric Functioning (Sleep) | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated. questionnaire which assesses sleep quality and disturbances. Range of scores: 0-21. Higher scores mean more sleep disturbance. | Posted | Mean | Standard Deviation | score on a scale | 3 Months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | tDCS (Active) | Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current Cognitive Behavioral Therapy for Pain: Cognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities. Transcranial Direct Current Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current | 1 | 65 | 0 | 65 | 2 | 65 |
| EG001 | tDCS (Sham) | Inactive (sham) Transcranial Direct Current Stimulation Cognitive Behavioral Therapy for Pain: Cognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities. Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex | 0 | 51 | 0 | 51 | 0 | 51 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin irritation as a result of wearing actigraphy wrist device |
| |
| Car accident | Social circumstances | Non-systematic Assessment | car accident unrelated to study procedures. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey J Borckardt, PhD | Ralph H. Johnson VA Medical Center, Charleston, SC & Medical University of South Carolina | 843.792.3295 | borckard@musc.edu |
| Aug 24, 2022 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 11, 2015 | Mar 26, 2021 | ICF_000.pdf |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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