Neuromodulation for Dysphoria

Launched by FLORIDA STATE UNIVERSITY · Sep 27, 2021

Keywords

ClinConnect Summary

This clinical trial, titled "Neuromodulation for Dysphoria," is exploring new treatments for dysphoria, which is a feeling of unease or dissatisfaction that can occur with various mental health conditions, including mood disorders and chronic pain. The study is testing two non-invasive therapies: Guided Meditation using Virtual Reality (VR) and Accelerated Transcranial Magnetic Stimulation (TMS). These treatments aim to provide relief without the need for medications, and they are designed to be more accessible and quicker to administer than traditional therapies.

To participate in the trial, you need to be an adult aged 18 or older and have symptoms of dysphoria, which may include feelings of sadness, anxiety, or chronic pain that have lasted for more than three months. Participants should not have made any changes to their psychiatric medications or therapy for at least a month before joining the study. During the trial, you can expect to receive the treatment over six weeks, and the researchers will monitor your progress to see how well these therapies work and how comfortable they are for you. It's important to note that certain medical conditions and concerns, such as severe brain injuries or active substance use disorders, would prevent someone from participating in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for Arm 1:
• • 1. Adults age 18 years and above
• • 2. Reported symptoms of dysphoria: PHQ-9 ≥ 10; GAD-7 ≥ 10; PCL-5 ≥ 45 or Average Pain Intensity ≥ 4/10 for \> 3 months - this will ensure at least moderate level of reported difficulty with mood, anxiety, trauma, or pain
• • 3. No changes in psychotropic medication (if taking psychotropic medication) and/or supportive psychotherapy for 1 month prior to baseline visit; and clinically appropriate to maintain stable treatment regimen for duration of trial.
• • 4. Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study
• Exclusion Criteria for Arm 1:
• • 1. Significant auditory or visual impairment that prevents participants from using Virtual Reality headset.
• • 2. Neurologic conditions or devices impacting brain circuitry (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)
• • 3. Active substance use disorder or hallucinogen use in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
• • 4. Dementia or other cognitive disorder making unable to engage in treatment
• • 5. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness that precludes safe participation in trial.
• • 6. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.
• • 7. OCD cannot be the primary disorder but can have OCD symptoms
• • 8. Inability to stop taking any medication that significantly increases cortical excitability (e.g., tricyclic antidepressants, stimulants, clozapine, etc.)
• • 9. Unstable medical conditions or any current medical condition that could preclude being able to safely participate in this phase of the study (e.g., unstable metabolic abnormality, unstable angina, etc.)
• • 10. Severe Traumatic Brain Injury
• • 11. We will exclude non-English speakers because of the need for rapid communication before and during the use of technology.
• • 12. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).
• • 13. The following groups will NOT be included.
• • Adults unable to consent
• • Individuals who are not yet adults (infants, children, teenagers)
• • Prisoners
• Inclusion for Arms 2 and 3:
• • 1. Adults age 18 years and above
• • 2. Reported symptom of dysphoria: PHQ-9 ≥ 10; GAD-7 ≥ 10; PCL-5 ≥ 45 or Average Pain ≥ 4/10 for \> 3 months - this will ensure at least moderate level of reported difficulty with mood, anxiety, trauma, or pain
• • 3. No changes in psychotropic medication (if taking psychotropic medication) and/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of trial
• • 4. Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study
• Exclusion for Arms 2 and 3 :
• • 1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)
• • 2. Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
• • 3. Dementia or other cognitive disorder making unable to engage in treatment
• • 4. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, delusional Disorder or other psychotic illness that precludes safe participation in trial
• • 5. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide
• • 6. OCD cannot be the primary disorder but can have OCD symptoms
• • 7. Inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
• • 8. Current, planned, or suspected pregnancy
• • 9. Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.)
• • 10. Severe Traumatic Brain Injury
• • 11. We will exclude non-English speakers because of the need for rapid communication during the delivery of treatments
• • 12. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).
• • 13. The following groups will NOT be included.
• • Adults unable to consent
• • Individuals who are not yet adults (infants, children, teenagers)
• • Pregnant women
• • Prisoners