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

NCT02844946 | Completed Results

• 1 other identifier: D2209-P
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Traumatic Brain Injury; Distress-based Psychopathology; Chronic Pain

Keywords

Acceptance and Commitment Therapy; mild Traumatic Brain Injury; Veterans; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (4)

• World Health Organization-Quality of Life (WHO-QOL)

  Quality of Life. The general Quality of Life scale includes 2 items that measure overall QOL and general health. Items scored are scored from 1-5 so the range for the this scale is 2-10 with higher scores representing higher quality of life.

  Through study completion, an average of 3 months following workshop attendance

• Depression Anxiety and Stress Scale (DASS-21)

  Consists of three self-report scales that measure current depression, anxiety, and stress. This 21-item measure consists of three self-report scales that measure current symptoms of depression, anxiety, and stress and a total score. It has been used extensively in clinical trials, including those with military populations. Higher scores represent greater distress and scores range from 0-126.

  Through study completion, an average of 3 months following workshop attendance

• Brief Pain Inventory (BPI)

  Assesses the severity of pain and the impact of pain on daily functions. The BPI severity scale assesses pain at its "worst," "least," "average," and "now" (current pain). A composite of the four pain items (a mean severity score) is used here as recommended for assessing pain in clinical trials. Higher scores represent greater severity (0-10).

  Through study completion, an average of 3 months following workshop attendance

• World Health Organization Disability Assessment Schedule II (WHODAS-II)

  Assesses functioning and disability due to health conditions. Six domains are covered: understanding and communicating, getting around, self-care, getting along with people, life act. This is a self-report measure that assesses behavioral and functional impairments as a separate domain from disease symptoms. Higher scores indicate higher disability (from 0-100).

  Through study completion, an average of 3 months following workshop attendance

Secondary Outcomes (3)

• Military to Civilian Questionnaire (M2C-Q)

  Through study completion, an average of 3 months following workshop attendance

• PTSD Checklist-Civilian Version (PCL-C)

  Through study completion, an average of 3 months following workshop attendance

• Acceptance and Action Questionnaire-II (AAQ-II)

  Through study completion, an average of 3 months following workshop attendance

Study Arms (2)

ACT on Life

EXPERIMENTAL

One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life's challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.

Behavioral: Acceptance and Commitment Therapy

Treatment as Usual

NO INTERVENTION

Veterans will continue receiving care as usual.

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

ACT on Life

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Clinically significant psychological distress as operationalized by a diagnosis of major depressive disorder, generalized anxiety disorder, or PTSD
• Life time history of Mild TBI
• the Department of Veterans Affairs and the Department of Defense define TBI as a traumatically induced structural injury and/or physiological disruption of brain function that is associated with any period of loss of or a decreased level of consciousness
• any loss of memory for events immediately before or after the injury
• any alteration in mental state at the time of the injury
• neurological deficits that may or may not be transient
• or an intracranial lesion
• Mild TBI is characterized by loss of consciousness less than 30 minutes, a period of post-traumatic amnesia less than 24 hours or, if available, a Glasgow Coma Scale score of 13 to 15
• Presence in medical chart of chronic pain including headache, musculoskeletal pain or neuropathic pain
• Stable dose of psychiatric medications for the past 8 weeks

You may not qualify if:

• History of primary psychotic disorder, e.g.,:
• schizophrenia
• schizoaffective disorder
• A diagnosis of substance dependence in the year prior to enrollment in the study
• Active suicidal ideation
• Homicidal ideation

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Dindo L, Johnson AL, Lang B, Rodrigues M, Martin L, Jorge R. Development and evaluation of an 1-day Acceptance and Commitment Therapy workshop for Veterans with comorbid chronic pain, TBI, and psychological distress: Outcomes from a pilot study. Contemp Clin Trials. 2020 Mar;90:105954. doi: 10.1016/j.cct.2020.105954. Epub 2020 Feb 4.

  PMID: 32032736 RESULT

MeSH Terms

Conditions

Brain Concussion; Chronic Pain; Stress Disorders, Post-Traumatic

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Lilian Dindo
• Organization: Baylor College of Medicine

lilian.dindo@bcm.edu

713-440-4637

Study Officials

• Lilian N. Dindo, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 26, 2016
• Study Start: October 3, 2016
• Primary Completion: September 3, 2018
• Study Completion: December 31, 2018
• Last Updated: December 2, 2021
• Results First Posted: August 28, 2019

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)