Repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy
Integrated Repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy for Veterans With Chronic Pain and Depression
2 other identifiers
interventional
31
1 country
1
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. To address this problem, the proposed research will examine the feasibility of a novel approach that integrates repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy with the overall goal of maximizing functional improvement in Veterans with chronic pain and depression. This is an important first-step in preparation for a future randomized efficacy trial. The investigators will also include two cognitive control tasks with concurrent electroencephalography to explore as a potential objective indicator of treatment response. This application addresses a critical need within the Veterans Health Administration and is closely aligned with the focus area of developing suicide prevention treatments that influence participation in life roles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable chronic-pain
Started May 2023
Typical duration for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2022
CompletedFirst Posted
Study publicly available on registry
June 22, 2022
CompletedStudy Start
First participant enrolled
May 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedJune 8, 2025
June 1, 2025
2 years
June 15, 2022
June 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PROMIS Pain Interference change
The PROMIS Pain Interference questionnaire consists of 8-items that assess the degree to which pain interferes with various aspects of life, including mobility, social activity, and mood. Items are scored on a 1 ("Not at all") to 5 ("Very much") scale with a range of 8 - 40. Higher scores indicate greater pain interference.
Baseline, weekly during ACT intervention, 9 weeks
Secondary Outcomes (2)
Patient Health Questionnaire-9 (PHQ-9) change
Baseline, weekly during ACT intervention, 9 weeks
PROMIS Pain Intensity change
Baseline, weekly during ACT intervention, 9 weeks
Study Arms (2)
DLPFC-rTMS + ACT
EXPERIMENTALActive DLPFC-rTMS with ACT treatment
Sham-rTMS + ACT
ACTIVE COMPARATORSham delivered rTMS with ACT treatment
Interventions
rTMS is a non-invasive brain stimulation technique designed to alter network function
ACT is a mindfulness-based cognitive behavioral intervention that has demonstrated efficacy for chronic pain.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Herbert, PhD
VA San Diego Healthcare System, San Diego, CA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2022
First Posted
June 22, 2022
Study Start
May 22, 2023
Primary Completion
May 30, 2025
Study Completion
May 30, 2025
Last Updated
June 8, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Indefinitely
- Access Criteria
- January, 2025
A data repository will be created upon completion of the study. Data obtained in this study that has scientific value to other qualified researchers will made available upon request. Interested researches will be able to access de-identified data through a Data Use Agreement.