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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02844946

Enrollment

Registered

2016-07-26

Start date

2016-10-03

Completion date

2018-12-31

Last updated

2021-12-02

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

Conditions

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

Keywords

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

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.

Detailed description

Traumatic brain injury (TBI) is the signature wound of Veterans returning from Operations Iraqi Freedom, Enduring Freedom and Operation New Dawn (OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Among those with a mild TBI (mTBI) diagnosis, the majority also suffers from stress-based psychopathology, including depression, post-traumatic stress disorder, and other anxiety disorders, as well as persistent pain. Poor management of multiple conditions results in increased morbidity and mortality, increased risk for suicide, and significantly decreased quality of life. Importantly, the association between seeking mental health care and stigma among Veterans is high. Veterans are often unwilling to seek mental health services due to concern that receiving such care would negatively impact their careers and the belief that they should be able to overcome psychological difficulties on their own. Furthermore availability of specialty services is limited for Veterans living in rural settings. Thus the challenge for treatment providers is to provide a unified, efficient, accessible, and acceptable intervention for Veterans with these interdependent systemic comorbid concerns. Acceptance and Commitment Therapy (ACT) is a trans-diagnostic (i.e., applies to more than one diagnosis) behavioral intervention aimed at helping individuals develop the skills needed to pursue valued goals and directions in the face of life's challenges. It provides a unified model of behavior change that has shown promise in treating depression and anxiety, as well as chronic medical conditions. Importantly, ACT has been effectively implemented in various treatment-delivery formats, including 1-day workshops. This flexibility in delivery format allows focus to be placed on how best to package and deliver the intervention to meet the needs of this Veteran patient population, to ensure treatment adherence, and also to increase chances of dissemination into clinical settings. Providing a 1-day ACT workshop for Veterans with mTBI, pain, and mental health problems will allow unitary comprehensive care for the range of emotional, physical, and cognitive symptoms experienced by these Veterans. Presenting the treatment as a workshop rather than therapy will also be better suited for the Veterans who may not be explicitly seeking specialized mental health care. Finally, a 1-day workshop ensures treatment adherence and completion, the lack of which is often the greatest obstacle to effective delivery of mental health services. The aims of this study are to: 1. develop a 1-day (5-hour) ACT on Life workshop tailored specifically for Veterans with mTBI, stress-based psychopathology, and pain; a multi-disciplinary team of a clinical psychologist, neuropsychiatrist, cognitive psychologist, and anthropologist will provide expert input for use in producing the therapist intervention and patient manual; 2. enroll 10 Veterans with mTBI, stress-based psychopathology, and pain in the ACT on Life workshop to obtain qualitative and quantitative feedback from Veterans about the intervention; use Veteran feedback to refine the treatment procedures and manuals; and examine feasibility and acceptability of the intervention; (this is called Pilot 1 and is the first time we recruited participants to obtain feedback on the intervention); and 3) randomize 30 Veterans with mTBI, pain, and stress-based psychopathology to the refined ACT on Life workshop or to Treatment as usual (TAU) to examine the preliminary efficacy of the intervention on quality of life and functioning, stress-based symptoms of psychopathology, and pain interference (this is called Pilot 2 and quantitative feedback was obtained). The results section will reflect data from Pilot 2.

Interventions

BEHAVIORALAcceptance and Commitment Therapy

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 18-75 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
World Health Organization-Quality of Life (WHO-QOL)	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.
Depression Anxiety and Stress Scale (DASS-21)	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.
Brief Pain Inventory (BPI)	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).
World Health Organization Disability Assessment Schedule II (WHODAS-II)	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).

Secondary

Measure	Time frame	Description
PTSD Checklist-Civilian Version (PCL-C)	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.
Acceptance and Action Questionnaire-II (AAQ-II)	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.
Military to Civilian Questionnaire (M2C-Q)	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
ACT on Life 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. Acceptance and Commitment Therapy: 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.	19
Treatment as Usual Veterans will continue receiving care as usual.	12
Total	31

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	7	0

Baseline characteristics

Characteristic	Total	Treatment as Usual	ACT on Life
Acceptance and Action Questionnaire-II (AAQ-II)	28.4 units on a scale STANDARD_DEVIATION 3.2	29.5 units on a scale STANDARD_DEVIATION 3.7	27.3 units on a scale STANDARD_DEVIATION 2.8
Age, Continuous	37.2 years STANDARD_DEVIATION 6.1	34.7 years STANDARD_DEVIATION 5.8	37.7 years STANDARD_DEVIATION 6.3
Military to Civilian Questionnaire (M2C-Q)	2.0 units on a scale STANDARD_DEVIATION 0.23	2.0 units on a scale STANDARD_DEVIATION 0.27	2.0 units on a scale STANDARD_DEVIATION 0.21
PTSD Checklist-Civilian Version (PCL-C)	56.2 units on a scale STANDARD_DEVIATION 4.6	56.2 units on a scale STANDARD_DEVIATION 5.4	56.3 units on a scale STANDARD_DEVIATION 4.3
Race/Ethnicity, Customized African American	6 Participants	2 Participants	4 Participants
Race/Ethnicity, Customized Hispanic/Latino	7 Participants	3 Participants	4 Participants
Race/Ethnicity, Customized Other	5 Participants	2 Participants	3 Participants
Race/Ethnicity, Customized White	13 Participants	5 Participants	8 Participants
Region of Enrollment United States	31 Participants	12 Participants	19 Participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	31 Participants	12 Participants	19 Participants
The Brief Pain Inventory (BPI) Severity	5.0 units on a scale STANDARD_DEVIATION 0.4	4.5 units on a scale STANDARD_DEVIATION 0.5	5.5 units on a scale STANDARD_DEVIATION 0.4
The Depression Anxiety and Stress Scale (DASS-21)	55.1 units on a scale STANDARD_DEVIATION 7.2	59.7 units on a scale STANDARD_DEVIATION 8	53.4 units on a scale STANDARD_DEVIATION 6.3
World Health Organization Disability Assessment Schedule II (WHODAS-II)	40.9 units on a scale STANDARD_DEVIATION 6	40.8 units on a scale STANDARD_DEVIATION 7.1	40.9 units on a scale STANDARD_DEVIATION 5.2
World Health Organization-Quality of Life (WHO-QOL)	5.7 units on a scale STANDARD_DEVIATION 1.9	5.17 units on a scale STANDARD_DEVIATION 1.9	6.11 units on a scale STANDARD_DEVIATION 1.97

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 19	0 / 12
other Total, other adverse events	0 / 19	0 / 12
serious Total, serious adverse events	0 / 19	0 / 12

Outcome results

Primary

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).

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