Status:
COMPLETED
Repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy
Lead Sponsor:
VA Office of Research and Development
Conditions:
Chronic Pain
Depression
Eligibility:
All Genders
Phase:
NA
Brief Summary
Veterans with comorbid chronic pain and depression are highly prevalent, have poor functional status and low quality of life, are at increased risk of suicide and lack access to effective treatments. ...
Detailed Description
Comorbid depression is highly prevalent in Veterans with chronic pain and contributes to greater pain severity, functional impairment, and suicide risk relative to those with chronic pain alone. Despi...
Eligibility Criteria
Inclusion
- Diagnosis of a chronic, non-terminal pain condition (pain most days for at least 6 months)
- Average pain intensity and interference with enjoyment of life and/or general activity rated \> 4/10 over the past week, as measured by the PEG
- Meet clinical criteria for major depression via DSM5 criteria, as assessed by the Mini International Neuropsychiatric Interview (MINI)
Exclusion
- Serious or unstable medical illness (e.g., cardiovascular disease)
- Lifetime history of psychotic disorder, bipolar disorder, obsessive-compulsive disorder
- Active substance abuse or psychosocial instability (e.g., homelessness) that could compromise study participation
- Changes to professionally delivered pain or mood treatment (e.g., no discontinuation of a treatment; no increasing the dose of medication) one month preceding the baseline assessment
- Significant neurologic disorder, increased risk of seizure for any reason or family/personal history of seizure
- Contraindications to rTMS treatment as outlined by the Safety of TMS Consensus group, which includes implanted metallic objects above the neck, implanted electrical devices (pacemakers/spinal cord stimulators), and pregnancy
- Prior trial of rTMS for any condition and/or lack of responsiveness to electroconvulsive therapy
Key Trial Info
Start Date :
May 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05427201
Start Date
May 22 2023
End Date
May 30 2025
Last Update
June 8 2025
Active Locations (1)
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1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002