Mild Traumatic Brain InjuryNCT02844946
One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology
A study testing Acceptance and Commitment Therapy in people with Mild Traumatic Brain Injury and Distress-based Psychopathology, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Distress-based Psychopathology, Chronic Pain
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
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.
Read the 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:
- 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;
- 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.
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Acceptance and Commitment Therapy, mild Traumatic Brain Injury, Veterans, Post Traumatic Stress Disorder
- Medical subject headings
- Brain Concussion, Chronic Pain, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Acceptance and Commitment Therapy |
| Treatment as Usual | No intervention | Veterans will continue receiving care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Through study completion, an average of 3 months following workshop attendance
Secondary outcomes (3)
Military to Civilian Questionnaire (M2C-Q)
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.
Measured: Through study completion, an average of 3 months following workshop attendance
PTSD Checklist-Civilian Version (PCL-C)
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.
Measured: Through study completion, an average of 3 months following workshop attendance
Acceptance and Action Questionnaire-II (AAQ-II)
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.
Measured: Through study completion, an average of 3 months following workshop attendance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start3 Oct 2016
- Primary completion3 Sep 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lilian N. Dindo, PhD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844946
- Sponsor's protocol ID
- D2209-P
- Status last verified
- Nov 2021
- First submitted
- 22 Jul 2016
- Last updated
- 2 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32032736
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology
- ClinicalTrials.gov ID
- NCT02844946
- Acronym / sponsor ID
- D2209-P
- Keywords
- Acceptance and Commitment Therapy, mild Traumatic Brain Injury, Veterans, Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 3 Sep 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT on Life | Experimental | Behavioral: Acceptance and Commitment TherapyOne 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. |
| Treatment as Usual | No intervention | –Veterans will continue receiving care as usual. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- 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
Key exclusion criteria (6 listed)
- History of primary psychotic disorder, e.g.,:
- A diagnosis of substance dependence in the year prior to enrollment in the study
- Active suicidal ideation
- Homicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyContextually 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. | Behavioural | ACT on Life |
Primary outcome
World Health Organization-Quality of Life (WHO-QOL)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
3 secondary outcomes
Military to Civilian Questionnaire (M2C-Q)
Time frame: Through study completion, an average of 3 months following workshop attendance
PTSD Checklist-Civilian Version (PCL-C)
Time frame: Through study completion, an average of 3 months following workshop attendance
Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: Through study completion, an average of 3 months following workshop attendance
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32032736Dindo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilian N. Dindo, PhD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Mild Traumatic Brain Injury and Distress-based Psychopathology, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization-Quality of Life (WHO-QOL) (time frame: Through study completion, an average of 3 months following workshop attendance). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02844946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.