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Behavioral Intervention
rTMS + ACT for Chronic Pain and Depression
N/A
Recruiting
Led By Matthew Herbert, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weekly during act intervention, 9 weeks
Awards & highlights
Study Summary
This trial will explore whether a novel approach that combines transcranial magnetic stimulation and acceptance and commitment therapy can help improve the quality of life for veterans with chronic pain and depression.
Who is the study for?
This trial is for veterans with chronic pain (pain most days for at least 6 months) and major depression. Participants must have a pain intensity >4/10, not be undergoing unstable medical treatments or substance abuse, and cannot have tried rTMS before or had no response to electroconvulsive therapy.Check my eligibility
What is being tested?
The study tests combining repetitive Transcranial Magnetic Stimulation (rTMS) with Acceptance and Commitment Therapy to improve function in veterans suffering from chronic pain and depression. It's a preliminary step towards a larger efficacy trial.See study design
What are the potential side effects?
Potential side effects of rTMS may include discomfort at the treatment site, headache, lightheadedness, seizures (rare), or hearing loss if ear protection isn't used during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pain has been over 4/10 and affects my life and activities.
Select...
I have been diagnosed with major depression according to DSM5.
Select...
I have been in pain most days for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weekly during act intervention, 9 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weekly during act intervention, 9 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PROMIS Pain Interference change
Secondary outcome measures
PROMIS Pain Intensity change
Patient Health Questionnaire-9 (PHQ-9) change
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DLPFC-rTMS + ACTExperimental Treatment2 Interventions
Active DLPFC-rTMS with ACT treatment
Group II: Sham-rTMS + ACTActive Control1 Intervention
Sham delivered rTMS with ACT treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acceptance and Commitment Therapy
2010
Completed Phase 1
~1490
Repetitive Transcranial Magnetic Stimulation
2013
Completed Phase 3
~1170
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,260 Total Patients Enrolled
76 Trials studying Depression
20,665 Patients Enrolled for Depression
Matthew Herbert, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
126 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't changed my pain or mood treatment in the last month.My pain has been over 4/10 and affects my life and activities.I don't have metal implants above the neck, electrical devices like pacemakers, or am not pregnant.I have been diagnosed with major depression according to DSM5.You have had a serious mental health condition like schizophrenia, bipolar disorder, or obsessive-compulsive disorder at any point in your life.I have been in pain most days for at least 6 months.I do not have any serious or unstable illnesses like heart disease.I have tried rTMS or did not respond to electroconvulsive therapy.I have a significant neurological disorder or a history of seizures.
Research Study Groups:
This trial has the following groups:- Group 1: DLPFC-rTMS + ACT
- Group 2: Sham-rTMS + ACT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for participants in this research study?
"As reported on clinicaltrials.gov, this trial is not presently accepting applicants. The research was initially advertised on September 1st 2023 and has since been revised as recently as November 4th 2022. Although no longer recruiting patients for the study, 1674 other trials are open to participants currently."
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