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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Treatment as Usual | No Intervention | Veterans will continue receiving care as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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.,:
A diagnosis of substance dependence in the year prior to enrollment in the study
Active suicidal ideation
Homicidal ideation
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| Name | Affiliation | Role |
|---|---|---|
| Lilian N. Dindo, PhD | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32032736 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Treatment as Usual | Veterans will continue receiving care as usual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of note, initially 27 participants were assigned to the ACT on Life Condition. However, only 19 of those were eligible, with valid data, and actually began the workshop.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop. | Posted | Mean | Standard Error | units on a scale | Through study completion, an average of 3 months following workshop attendance |
|
Through study completion, up to 3 months following workshop attendance.
This is a low-risk study. The investigators are simply providing a workshop to Veterans to teach them more about their difficulties and new ways they may cope. However, if at any time during the study we obtained information about significant and imminent suicidality, we would follow-up by doing a suicide risk assessment and making immediate referrals.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lilian Dindo | Baylor College of Medicine | 713-440-4637 | lilian.dindo@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2018 | Jun 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D059350 | Chronic Pain |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| 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. | 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. | Through study completion, an average of 3 months following workshop attendance |
| BG001 | Treatment as Usual | Veterans will continue receiving care as usual. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| World Health Organization-Quality of Life (WHO-QOL) | 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. | Mean | Standard Deviation | units on a scale |
|
| The Depression Anxiety and Stress Scale (DASS-21) | 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. | Mean | Standard Deviation | units on a scale |
|
| The Brief Pain Inventory (BPI) Severity | 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). | Mean | Standard Deviation | units on a scale |
|
| World Health Organization Disability Assessment Schedule II (WHODAS-II) | 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). | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Treatment as Usual | Veterans will continue receiving care as usual. |
|
|
| Primary | 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. | 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop. | Posted | Mean | Standard Error | units on a scale | Through study completion, an average of 3 months following workshop attendance |
|
|
|
| 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). | 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop. | Posted | Mean | Standard Deviation | units on a scale | Through study completion, an average of 3 months following workshop attendance |
|
|
|
| Primary | 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). | 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop. | Posted | Mean | Standard Error | units on a scale | Through study completion, an average of 3 months following workshop attendance |
|
|
|
| Secondary | 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. | 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop. | Posted | Mean | Standard Error | units on a scale | Through study completion, an average of 3 months following workshop attendance |
|
|
|
| Secondary | 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. | 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop. | Posted | Mean | Standard Error | units on a scale | Through study completion, an average of 3 months following workshop attendance |
|
|
|
| Secondary | 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. | 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop. | Posted | Mean | Standard Error | units on a scale | Through study completion, an average of 3 months following workshop attendance |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Treatment as Usual | Veterans will continue receiving care as usual. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |