NCT02844946

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

Completed NA Results posted Last updated 2 December 2021

What this trial tests

NA trial testing Acceptance and Commitment Therapy in Mild Traumatic Brain Injury in 39 participants. Completed in 31 December 2018.

Timeline

3 October 2016

Primary endpoint
3 September 2018

31 December 2018

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	39
Start date	3 October 2016
Primary completion	3 September 2018
Estimated completion	31 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Acceptance and Commitment Therapy

Conditions studied

• Mild Traumatic Brain Injury — all drugs for Mild Traumatic Brain Injury →
• Distress-based Psychopathology — all drugs for Distress-based Psychopathology →
• Chronic Pain — all drugs for Chronic Pain →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 75, any sex, with Mild Traumatic Brain Injury or Distress-based Psychopathology. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

World Health Organization-Quality of Life (WHO-QOL) Primary · Through study completion, an average of 3 months following workshop attendance

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.

Group	Value	95% CI
ACT on Life	6.11	± 1.94
Treatment as Usual	5.20	± 1.55

Depression Anxiety and Stress Scale (DASS-21) Primary · Through study completion, an average of 3 months following workshop attendance

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.

Group	Value	95% CI
ACT on Life	42.7	± 6.3
Treatment as Usual	65.6	± 8.3

Brief Pain Inventory (BPI) Primary · Through study completion, an average of 3 months following workshop attendance

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).

Group	Value	95% CI
ACT on Life	5.3	± .5
Treatment as Usual	4.2	± .7

World Health Organization Disability Assessment Schedule II (WHODAS-II) Primary · Through study completion, an average of 3 months following workshop attendance

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).

Group	Value	95% CI
ACT on Life	38.3	± 5.6
Treatment as Usual	41.7	± 7.7

Military to Civilian Questionnaire (M2C-Q) Secondary · Through study completion, an average of 3 months following workshop attendance

This 16-item self-report measure assesses post-deployment difficulties with reintegration during the previous month. Respondents rate the level of difficulty on a 5-point scale from No Difficulty to Extreme Difficulty (0-4). The following domains are covered by the M2C-Q: Social relations, community engagement, perceived meaning in life, self-care and leisure, and parenting. The total score is the average of the 16 items. Higher scores reflecting greater difficulty with reintegration.

Group	Value	95% CI
ACT on Life	1.81	± .22
Treatment as Usual	2.14	± .30

PTSD Checklist-Civilian Version (PCL-C) Secondary · Through study completion, an average of 3 months following workshop attendance

PCL-C is a 17-item self-report questionnaire assessing the presence and severity of DSM-IV symptoms of PTSD during the past month. All items are added for a total severity score. Higher scores represent greater severity of PTSD symptoms. Scores range from 1-85.

Group	Value	95% CI
ACT on Life	49.2	± 3.8
Treatment as Usual	54.4	± 4.8

Acceptance and Action Questionnaire-II (AAQ-II) Secondary · Through study completion, an average of 3 months following workshop attendance

The AAQ-II is an ACT-specific self-report measure of psychological inflexibility. Seven items are rated on a 7-point scale, ranging from 1 ("never true") to 7 ("always true"), with higher scores reflecting greater inflexibility. Scores range from 1-49. Example items include, "Emotions cause problems in my life," and "My painful memories prevent me from having a fulfilling life." It has been shown to have good internal consistency and validity and also to mediate behavioral outcomes in ACT interventions.

Group	Value	95% CI
ACT on Life	22.8	± 2.8
Treatment as Usual	30.3	± 3.8

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Dindo L, Johnson AL, Lang B, Rodrigues M, et al · · 2020 · cited 26× · PMID 32032736 · DOI 10.1016/j.cct.2020.105954