CompletedNot Applicable

One-day Life Skills Workshop for Veterans With TBI, Pain, and Psychopathology: Evaluating Efficacy and Mechanism of Change

United States176 participantsStarted 2020-07-01

Plain-language summary

Mild traumatic brain injury (mTBI) is the signature wound of Veterans returning from the operations in Iraq and Afghanistan (i.e., OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Among Veterans with mTBI, the majority also experience stress-based psychopathology (e.g., depression, post-traumatic stress disorder, and/or generalized anxiety disorder) and chronic pain. To cope with distress, pain, and other difficulties, Veterans often turn to maladaptive avoidant coping strategies which offer short term relief but exacerbate/maintain mental health problems and have detrimental long-term effects on social, occupational, and community reintegration. Unfortunately, Veterans face important barriers to seeking mental health treatment, including stigma and logistical issues. This proposal aims to examine 1) the impact of a Veteran-centered, non-stigmatizing, 1-day "life skills group workshop" on overall distress and reintegration; and 2) the mechanisms by which this treatment might work as well as possible influences on treatment efficacy.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * OIF/OEF/OND Veteran * Stress-based psychopathology, as operationalized by a diagnosis of major depressive disorder, generalized anxiety disorder, or PTSD on the M.I.N.I. International Neuropsychiatric interview (M.I.N.I.) * Deployment-related mild TBI according to the definition of VA/DOD Clinical Practice Guidelines and determined by interview on the Boston Assessment of TBI-Lifetime (BAT-L) * Pain intensity and level of interference reported to be 5 (moderate) on the Defense and Veterans Pain Rating Scale (DVPRS) Exclusion Criteria: * History of bipolar disorder or primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder) on the M.I.N.I. * A current diagnosis of severe substance use disorder on the M.I.N.I. * Moderate to severe suicide risk on the suicidality scale on the M.I.N.I. * History of neurological illness not related to TBI (self-reported and confirmed by Dr. Jorge) * Severe medical illness (e.g. liver failure, severe coronary artery disease and /or heart failure) posing a new and significant stress burden and requiring intensive treatment (self-reported and confirmed by Dr. Jorge)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Depression Anxiety and Stress Scale (DASS-21) -TOTAL Score

Timeframe: Through study completion, an average of 6 months following workshop/intervention attendance.

Military to Civilian Questionnaire (M2C-Q)

Timeframe: Through study completion, an average of 6 months following workshop/intervention attendance.

Trial details

NCT IDNCT04143243

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-08-03

Results submitted2025-08-01

View on ClinicalTrials.gov More Traumatic Brain Injury trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The Depression Anxiety and Stress Scale (DASS-21) -TOTAL Score

Timeframe: Through study completion, an average of 6 months following workshop/intervention attendance.

Military to Civilian Questionnaire (M2C-Q)

Timeframe: Through study completion, an average of 6 months following workshop/intervention attendance.