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| ID | Type | Description | Link |
|---|---|---|---|
| HT94252411015 | Other Identifier | Department of Defense Traumatic Brain Injury and Psychological Health Research Program |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The investigators want to test a treatment for posttraumatic stress disorder (PTSD) especially designed for military veterans and service members with mild or moderate traumatic brain injuries (TBI) and PTSD. The treatment will include individual psychotherapy sessions to manage PTSD.
The objective of this study is to test a non-trauma intervention for PTSD tailored to military veterans and service members with TBI called Non-Trauma Treatment for TBI and comorbid PTSD (T3 PTSD).
Aim1:
Conduct a pilot study of the non-trauma intervention for comorbid TBI and PTSD in a sample of n = 20 veterans and service members seeking treatment at Fort Hood, Texas.
Aim2:
Establish the acceptability and feasibility of the non-trauma intervention in service members and veterans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active duty service members and veterans seeking clinical care for TBI | Experimental | Male and female active duty service members and veterans at least 18 years of age who are seeking clinical care for mild or moderate Traumatic Brain Injury (TBI) symptoms at the Intrepid Spirit Center located on Fort Hood who also have a co-occurring diagnosis of PTSD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Trauma Treatment for TBI and PTSD | Behavioral | The treatment includes 8 sessions with each session lasting approximately 60 minutes. Sessions will cover relaxation training, identifying stress, stress management, and problem solving. |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist-DSM-5 (PCL-5) | The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. The scoring involves summing the responses to 20 items (0 to 80) with higher scores indicating more severe PTSD. | Baseline to 6 months post treatment (approximately 8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Credibility and Expectancy Questionnaire | A 6-item measure that was designed to assess treatment expectancy and rationale credibility for use in clinical outcomes studies. The measure is scored on an 8-point scale with higher scores indicating higher credibility and expectancy. | Baseline to 2 weeks post treatment (approximately 10 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cindy McGeary, PhD | Contact | 210-567-5497 | mcgearyc@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cindy McGeary, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl R Darnall Army Medical Center | Recruiting | Fort Hood | Texas | 76544 | United States |
Individual Participant data may be shared with the research study team, the IRB, the Department of Defense representatives and state or Federal Government officials where required by law. Only deidentified data will be shared in a peer reviewed journal or in the summary results in ClinicalTrials.gov.
Public data will be shared at the end of the study after the data is analyzed.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
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| ID | Term |
|---|---|
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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This study is a single group pilot test
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| Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders Version 5 (DSM-5) |
The CAPS-5 contains 20-items measuring PTSD symptoms, scored on a 5-point scale with scores ranging from 0-80. Higher scores indicate greater PTSD severity. |
| Baseline to 6 months post treatment (approximately 8 months) |
| Generalized Anxiety Disorder-7 (GAD-7) | This 7-item measure asks participants to rate the frequency with which they have been bothered by anxiety symptoms within the past 2 weeks. Scores range from 0=not at all to 3=nearly every day, with totals from 0-21, with a higher score indicating greater anxiety. | Baseline to 6 months post treatment (approximately 8 months) |
| Patient Global Impressions (PGI) Scale | A 2-item survey where each item is scored out of 7. Total score is 0-14, where a lower score indicates less feeling of illness and greater improvement | 2 weeks post treatment to 6 months post treatment |
| Alcohol Use Disorders Identification Test (AUDIT) | A self report, 10-item survey with items scored from 0-4. Total scores range from 0-40, with a higher score indication greater alcohol consumption. | Baseline to 6 months post treatment (approximately 8 months) |
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a widely used and well-validated 9-item instrument for measuring the severity of depressive symptoms. Each item is scored from 0=not at all to 3=nearly every day giving a possible range of score from 0-27. A lower score indicates better health and well-being | Baseline to 6 months post treatment (approximately 8 months) |
| Depressive Symptom Index-Suicide Subscale (DSI-SS) | This 4-item self-report measure of suicidal ideation has excellent internal consistency and concurrent validity. Items are scored 0-3, giving a total range of 0-12, with a higher score indicating more severe suicidal ideation. | Baseline to 6 months post treatment (approximately 8 months) |
| Insomnia Severity Index (ISI) | A 7 item scale scored from 0-4 for each item. Total scores range from 0-28 with a higher score indicating worse insomnia. | Baseline to 6 months post treatment (approximately 8 months) |
| Life Events Checklist-5 (LEC-5) | The LEC-5 includes a list of 16 potentially traumatic life events commonly associated with PTSD symptoms, along with an additional item (17) that allows respondents to describe any other stressful events or experience. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3= learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). Total scores range from 6-102, with a higher score indicating less traumatic events. | Baseline to 6 months post treatment (approximately 8 months) |
| Satisfaction with Therapy and Therapist Scale (STTS) | A 12-item self-report measure with strong psychometric properties used to assess the patient's satisfaction with the therapy provided and the therapist. Even number items assess satisfaction with therapy and odd number items assess satisfaction with therapist. Scores range between 5-60 with higher scores reflective of greater satisfaction. Items are on a 5-point Likert scale that ranges from 1 = "Strong disagree" to 5 = "Strongly Agree'. Additionally, a 13th item provides an independent assessment of the patient's global improvement. | 2 weeks post treatment (approximately 10 weeks after the first treatment) |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |