Carl R Darnall Army Medical Center
Fort Hood, Texas, 76544, United States
Location status: Recruiting
NCT Number: NCT07351305
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Fort Hood, Texas, 76544, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The treatment includes 8 sessions with each session lasting approximately 60 minutes. Sessions will cover relaxation training, identifying stress, stress management, and problem solving.
Other names: T3 PTSD
Time frame: Baseline to 6 months post treatment (approximately 8 months)
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.
Time frame: Baseline to 2 weeks post treatment (approximately 10 weeks)
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.
Time frame: Baseline to 6 months post treatment (approximately 8 months)
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.
Time frame: Baseline to 6 months post treatment (approximately 8 months)
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.
Time frame: 2 weeks post treatment to 6 months post treatment
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
Time frame: Baseline to 6 months post treatment (approximately 8 months)
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.
Time frame: Baseline to 6 months post treatment (approximately 8 months)
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
Time frame: Baseline to 6 months post treatment (approximately 8 months)
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.
Time frame: Baseline to 6 months post treatment (approximately 8 months)
A 7 item scale scored from 0-4 for each item. Total scores range from 0-28 with a higher score indicating worse insomnia.
Time frame: Baseline to 6 months post treatment (approximately 8 months)
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.
Time frame: 2 weeks post treatment (approximately 10 weeks after the first treatment)
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.
Contact information is provided by the study sponsor or research team.
The University of Texas Health Science Center at San Antonio
Other
Non-Trauma Intervention to Treat Posttraumatic Stress Disorder (PTSD) for Veterans and Service Members Suffering From a Traumatic Brain Injury (TBI)
Acronym: T3 for PTSD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07473505
Anxiety, Anxiety Disorders
Strongsville, Ohio, United States
View Trial DetailsNCT06494319
Brain Diseases, Brain Injuries
Houston, Texas, United States
View Trial DetailsNCT03615222
Alcohol Use Disorder, Alcohol-Related Disorders
Temple, Texas, United States
View Trial DetailsNCT03539068
Behavior, Behavioral Symptoms
Iowa City, Iowa, United States
View Trial Details