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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04143243

Enrollment

176

Registered

2019-10-29

Start date

2020-07-01

Completion date

2024-08-03

Last updated

2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Chronic Pain, Depression, Post Traumatic Stress Disorder, Traumatic Brain Injury

Keywords

Acceptance and Commitment Therapy, Veterans, polytrauma, traumatic brain injury, chronic pain, Post Traumatic Stress Disorder, depression, Anxiety

Brief 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.

Detailed description

Traumatic brain injury (TBI) is the signature wound of Veterans returning from Operations Iraqi Freedom, Operation Enduring Freedom and Operation New Dawn (OIF/OEF/OND), with up to 20 percent exposed to a mild TBI (mTBI) and experiencing persistent post-concussive symptoms. Among those with a mTBI diagnosis, the majority also suffers from stress-based psychopathology (e.g., depression, post-traumatic stress disorder, generalized anxiety disorder), as well as 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 significant barriers to engaging in mental health treatment, including stigma, the belief that one should overcome psychological difficulties on his/her own, and concern that receiving such care would negatively impact their careers. Practical barriers, including time constraints, distance from a treatment facility, and competing priorities (e.g., work and family demands), are also barriers to care. Even among Veterans who start mental health treatment, only a small minority complete a recommended course of evidence-based therapy. Acceptance and Commitment Therapy (ACT) is a trans-diagnostic treatment model that helps patients to overcome avoidance by promoting acceptance-based coping and engagement in meaningful life activities. In this context, Veterans are asked to think about their new mission(s) after leaving the military and the importance of engaging in actions that fulfill their mission even when it may be difficult. ACT has established efficacy in the treatment of depression, anxiety, and chronic pain, and has been effectively implemented in various treatment-delivery formats, including 1-day group workshops. A 1-day ACT workshop addresses specific needs of Veterans with mTBI, stress-based psychopathology, and chronic pain (polytrauma triad) and important barriers to treatment. It 1) is trans-diagnostic (i.e., applies to more than one condition); 2) targets avoidance-based coping; 3) cultivates acceptance-based coping and builds on Veteran's values and goals to motivate them to make difficult decisions; 4) is delivered efficiently and thus more accessible; 5) is less stigmatizing and thus acceptable; and 6) address problems with treatment adherence and completion. With the support of an RR&D SPiRE pilot grant, the PIs developed a 1-day 'ACT on Life' workshop tailored specifically for the needs of Veterans with mTBI, stress-based psychopathology, and chronic pain. Veterans with this polytrauma were then randomly assigned to the 'ACT on Life' workshop (N=20) or to Treatment as Usual (TAU; N=12). All Veterans attending the 1-day ACT workshop completed it, and relative to TAU, exhibited greater improvements in distress and reintegration at the 3-month follow-up (effect sizes .68 and .47, respectively). Building on these promising preliminary findings, the investigators now propose to conduct a more rigorous randomized controlled trial with 212 Veterans to compare the efficacy of the 1-day ACT workshop to an active treatment comparison (Education, Resources, and Support; ERS) on symptoms of distress and social, occupational, and community reintegration. The investigators will also examine mediators and moderators of treatment response to identify which ACT components are directly responsible for treatment effectiveness and whether treatment benefits are constrained by various personal factors. Establishing the efficacy of a 1-day ACT workshop for OEF/OEF/OND Veterans with mTBI and multiple coexistent conditions addresses key priorities of VHA RR&D: 1. developing interventions which will improve the psychological health status of Veterans who have specific needs; and 2. enhancing the community, social, and occupational reintegration and functioning of post-deployment Veterans so that they may function more fully in society.

Interventions

BEHAVIORALACT on Life

1 day group workshop of ACT plus ERS

BEHAVIORALEducation, Resources, and Support

1 day group workshop of Education, Resources, and Support

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Patients will not be told which group they are being allocated to. Follow-up assessments will be administered by anl interviewer blinded to patient assignment.

Intervention model description

ACT plus Education, Resources and Support ('ACT on Life') workshop compared to Education, Resources, & Support only workshop (ERS)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
The Depression Anxiety and Stress Scale (DASS-21) -TOTAL Score	Through study completion, an average of 6 months following workshop/intervention attendance.	The Depression Anxiety and Stress Scale (DASS-21) measure consists of 21 items that measure current symptoms of depression, anxiety, and stress with a total score. It has been used extensively in clinical trials, including those with military populations. Participants are asked to rate the extent to which they have experienced each state over the past week with a 4-point scale (from 0 = did not apply to me at all to 3 = applied to me very much). For total score, scores are summed and range from 0 to 63. Higher total scores indicate more severe symptoms of depression, anxiety and stress.
Military to Civilian Questionnaire (M2C-Q)	Through study completion, an average of 6 months following workshop/intervention attendance.	The Military to Civilian Questionnaire (M2CQ) is a 16-item self-report measure used to assess the difficulty veterans experience during the post-deployment reintegration process. A total score is calculated by dividing the sum of the item scores by the number of items the veteran completed (excluding those marked Does not apply).The Minimum possible score is 0 (if all items are answered as no difficulty or does not apply). Maximum possible score is 4 (if all items are answered as extreme difficulty). Higher scores on the M2CQ indicate greater difficulty with reintegration into civilian life.

Secondary

Measure	Time frame	Description
The PTSD Checklist for DSM-5 (PCL-5)	Through study completion, an average of 6 months following workshop/intervention attendance.	The PCL-5 is a 20-item self-report questionnaire to assess post-traumatic stress disorder (PTSD) based on criteria of the Diagnostic and Statistical Manual for Mental Disorders - Version 5 (DSM-5). This scale is available from the National Center for PTSD and is extensively used in Veteran populations. Each item is rated on a 5-point scale with anchors from not at all to extremely indicating how much the participant has been bothered by the PTSD symptoms in the past month. A total symptom severity score can be obtained by summing the scores for a range of scores from 0 to 80. A higher total score demonstrates more severe PTSD symptoms.
Defense and Veterans Pain Rating Scale (Pain Severity)	Through study completion, an average of 6 months following workshop/intervention attendance.	The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool that assesses severity of pain. It uses a numerical scale ranging from 0 to 10 to assess pain intensity. Minimum Score: 0, representing No pain. Maximum Score: 10, representing As bad as pain can be, nothing else matters. It is a reliable and valid instrument developed for use in military populations.

Other

Measure	Time frame	Description
Valued Living Questionnaire (VLQ) - Success	Through study completion, an average of 6 months following workshop/intervention attendance.	Valued Living Questionnaire (VLQ) is a self-report measure that assesses engagement in valued areas of life. Participants first rate the importance of 10 life domains (e.g., family, work, friends etc.) on a 10-point Likert scale (1 = not at all important to 10 = extremely important). They then rate the degree to which their actions over the past week were consistent with each value, from 1 (not at all consistent) to 10 (extremely consistent). The success score is the VLQ Composite Score and refers to the composite score that measures how consistently a person is living in accordance with their stated personal values. The Valued Living composite is calculated by multiplying the Importance and Consistency responses for each domain and then calculating the mean of those scores. The resulting Valued Living Composite scores can range from 10-100. A higher score indicates greater alignment between actions and values, which is associated with positive psychological outcomes.
Self-reported Service Utilization (Emotional Problems)	Through study completion, an average of 6 months following workshop/intervention attendance.	The outcome measure is either Yes or No and then we computed the percentage of study participants that responded 'yes' on having utilized services for emotional problems from any of the following, medical provider, spiritual provider(priest/minister), psychiatric help or had hospital admission(in or outpatient) or ER admission.
Acceptance and Action Questionnaire-II	Through study completion, an average of 6 months following workshop/intervention attendance.	The Acceptance and Action Questionnaire-II (AAQ-II) is an ACT-specific self-report measure of psychological inflexibility. The AAQ was designed to measure mechanisms hypothesized to be at work in ACT treatments and has been found to mediate behavioral outcomes in ACT interventions. Seven items are rated on a 7-point scale, ranging from 1 (never true) to 7 (always true), with higher scores reflecting greater levels of psychological inflexibility. The total score is calculated by summing the ratings for each of the seven items. The minimum possible score is 7 (7 items x 1 point each).The maximum possible score is 49 (7 items x 7 points each). Higher total scores indicate greater levels of psychological inflexibility and experiential avoidance.

Countries

United States

Participant flow

Recruitment details

OIF/OEF/OND Veterans with deployment-related mTBI, stress-based psychopathology, and pain (polytrauma clinical triad) were recruited from VAMC, outpatient clinics and Veteran Community Organizations.

Pre-assignment details

Eligible participants were randomized at their enrollment following phone screening. They were excluded if imminent risk of suicide.

Participants by arm

Arm	Count
ACT on Life Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life'). The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour).	90
Education, Resources, and Support Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered	86
Total	176

Baseline characteristics

Characteristic	Total	Education, Resources, and Support	ACT on Life
Acceptance and Action Questionnaire-II (AAQ-II)	33.5 units on a scale STANDARD_DEVIATION 9.3	33.3 units on a scale STANDARD_DEVIATION 9.5	33.8 units on a scale STANDARD_DEVIATION 9.1
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	176 Participants	86 Participants	90 Participants
Age, Continuous	40.6 years STANDARD_DEVIATION 7.7	40.7 years STANDARD_DEVIATION 7.7	40.6 years STANDARD_DEVIATION 7.8
Defense and Veterans Pain Rating Scale (DVPRS)-Severity	6.2 units on a scale STANDARD_DEVIATION 1.4	6.3 units on a scale STANDARD_DEVIATION 1.5	6.1 units on a scale STANDARD_DEVIATION 1.4
Depression, Anxiety, and Stress Symptoms (DASS-21) -TOTAL Score	34.3 units on a scale STANDARD_DEVIATION 11.3	34.9 units on a scale STANDARD_DEVIATION 12	33.6 units on a scale STANDARD_DEVIATION 10.5
Ethnicity (NIH/OMB) Hispanic or Latino	43 Participants	24 Participants	19 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	120 Participants	55 Participants	65 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants	7 Participants	6 Participants
Military to Civilian Questionnaire (M2C-Q)	2.54 units on a scale STANDARD_DEVIATION 0.7	2.53 units on a scale STANDARD_DEVIATION 0.78	2.55 units on a scale STANDARD_DEVIATION 0.62
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	0 Participants	2 Participants
Race (NIH/OMB) Black or African American	53 Participants	25 Participants	28 Participants
Race (NIH/OMB) More than one race	8 Participants	6 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	45 Participants	24 Participants	21 Participants
Race (NIH/OMB) White	67 Participants	30 Participants	37 Participants
Region of Enrollment United States	176 Participants	86 Participants	90 Participants
Sex: Female, Male Female	26 Participants	13 Participants	13 Participants
Sex: Female, Male Male	150 Participants	73 Participants	77 Participants
The PTSD Checklist for DSM-5 (PCL-5)	50.8 units on a scale STANDARD_DEVIATION 14.8	51.9 units on a scale STANDARD_DEVIATION 15.4	49.7 units on a scale STANDARD_DEVIATION 14.2
Valued Living Questionnaire (VLQ)-Success	51.0 units on a scale STANDARD_DEVIATION 21.3	52.1 units on a scale STANDARD_DEVIATION 20.9	50.0 units on a scale STANDARD_DEVIATION 21.7

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 90	0 / 86
other Total, other adverse events	2 / 90	2 / 86
serious Total, serious adverse events	0 / 90	0 / 86

Outcome results

Primary

Military to Civilian Questionnaire (M2C-Q)

The Military to Civilian Questionnaire (M2CQ) is a 16-item self-report measure used to assess the difficulty veterans experience during the post-deployment reintegration process. A total score is calculated by dividing the sum of the item scores by the number of items the veteran completed (excluding those marked Does not apply).The Minimum possible score is 0 (if all items are answered as no difficulty or does not apply). Maximum possible score is 4 (if all items are answered as extreme difficulty). Higher scores on the M2CQ indicate greater difficulty with reintegration into civilian life.