CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Acceptance and Commitment Therapybehavioral
Likely dose
Not stated in record
Key inclusion· 5
  • Age 18-75 years
  • Clinically significant psychological distress with diagnosis of MDD, GAD, or PTSD
  • Lifetime history of mild TBI (LOC <30 min, post-traumatic amnesia <24 hours, or GCS 13-15)
  • Documented chronic pain (headache, musculoskeletal, or neuropathic)
Key exclusion· 4
  • History of primary psychotic disorder (schizophrenia, schizoaffective disorder)
  • Substance dependence in the year prior to enrollment
  • Active suicidal ideation
  • Homicidal ideation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02844946
NCT02844946N/ACompleted

One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology

VA Office of Research and Development·interventional·Posted Jul 26, 2016·Updated Dec 2, 2021

In Brief

A clinical study evaluating Acceptance and Commitment Therapy for Mild Traumatic Brain Injury and 2 related conditions. Completed, enrolled 39 participants across 1 site.

Detailed Summary

Traumatic brain injury (TBI) is the signature wound of Veterans returning from the recent operations in Iraq and Afghanistan (i.e OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Among Veterans with mild TBI, the majority also experience significant distress, including depression and post-traumatic stress disorder, as well as persistent pain. Importantly, significant stigma is associated with seeking mental health care among Veterans; and poor management of multiple conditions results in increased morbidity and mortality, increased risk for suicide, and significantly decreased quality of life. Thus the challenge for treatment providers is to provide a unified and acceptable intervention for Veterans with these interdependent systemic comorbid concerns. The aim of this proposal is to develop, refine, and evaluate a 1-day trans-diagnostic (i.e., applies to more than one diagnosis) "life skills workshop" to help Veterans develop skills needed to pursue valued goals in the face of life's challenges.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 26, 2016
Enrollment StartOct 3, 2016
Primary CompletionSep 3, 2018
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.9 years ago

Interventions

Acceptance and Commitment Therapybehavioral

Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.