Enhancing Psychotherapy for Veterans and Service Members with PTSD and Anxiety
NCT ID: NCT05843695
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
306 participants
INTERVENTIONAL
2023-09-22
2026-09-30
Brief Summary
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* Is iTCBT delivered in individual and group formats more effective than TAU in improving anxiety symptoms and quality of life?
* For treatment non-responders, is iTCBT-Enhanced more effective than TAU improving anxiety symptoms and quality of life?
* Does iTCBT-Individual produce a larger improvement in anxiety and quality of life compared with iTCBT-Group?
Participants will undergo several assessments throughout the course of the study. Based on randomization, they will receive: (1) iTCBT in an individual format over a 2-week period, (2) iTCBT in a group format over a 2-day period, or (3) usual care. Those who do not show a response to treatment will receive 4 additional individual therapy sessions.
Detailed Description
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Despite the debilitating nature of posttraumatic stress and anxiety, these disorders can be successfully treated with CBT. However, relatively few Veterans take advantage of these treatments. One explanation is that individual- and systemic- level barriers to treatment engagement are inherent in the structure of standard CBT delivery formats, which require weekly appointments over a 3 to 4-month period. Furthermore, because current CBTs are disorder-specific and often do not directly address psychiatric comorbidity, individuals frequently need to seek additional treatment after completing one course of CBT. These collective barriers point to the need for improved treatment delivery methods.
Transdiagnostic treatment approaches hold potential in addressing the many barriers associated with treatment engagement. Transdiagnostic approaches distill the same treatment principles embedded across different protocols for anxiety disorders and PTSD into a single protocol without targeting a specific disorder. Fear is a common element across these disorders but the source of fear and how symptoms manifest differentiates one disorder from another.
Although transdiagnostic approaches show excellent potential as a single treatment for multiple disorders, few studies to date have systematically examined the effectiveness of transdiagnostic treatment with a military population. Research also indicates that service members with anxiety disorders often prefer treatment in an individual therapy format. Group treatments typically show higher rates of dropout, which supports the importance of treating anxiety using individual formats. Similarly, given the many barriers associated with the structure of traditional psychotherapy delivery, more attention in recent years has been directed at examining intensive or massed treatment approaches in delivering trauma-focused treatment. Such approaches seek to shorten the overall length of treatment by providing psychotherapy in longer and stronger doses.
The proposed clinical trial tests two different delivery formats of iTCBT (Individual vs. Group) and the enhancement of iTCBT for participants who do now show significant improvement following a course of iTCBT. Veterans and service members with PTSD and anxiety will be recruited for the study. The extended version of iTCBT (iTCBT-E) will provide 6 additional hours of individual treatment over 2 weeks. Differences in outcomes between participants who receive the intervention in individual versus group formats will also be examined.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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iTCBT-I (Intensive Transdiagnostic Cognitive Behavioral Therapy-Individual)
Patients in this arm will receive transdiagnostic CBT delivered in an intensive individual format over 2 weeks. Intensive Transdiagnostic Cognitive Behavior Therapy-Individual (iTCBT-I): Participants randomized to this condition will receive 12 hours of treatment in four 3 hour sessions, over a 2-week period. Treatment consists of psychoeducation, cognitive restructuring, and exposure exercises.
For treatment non-responders (i.e., BAI score decrease \< 10), patients will receive 4 additional 90 minute sessions of individual therapy over a 2-week period (iTCBT-Enhanced). These sessions will identify areas where participants might benefit from more in-depth focus on specific concepts taught in the treatment.
iTCBT-I
Individual format over 2 weeks
iTCBT-G (Intensive Transdiagnostic Cognitive Behavioral Therapy-Group)
Patients in this arm will receive transdiagnostic CBT delivered in an intensive group format over 2 weeks. Intensive Transdiagnostic Cognitive Behavior Therapy-Group (iTCBT-G): Participants randomized to this condition will receive 12 hours of treatment over a 2-day period (6 hrs each day). Treatment consists of psychoeducation, cognitive restructuring, and exposure exercises.
For treatment non-responders (i.e., BAI score decrease \< 10), patients will receive 4 additional 90 minute sessions of individual therapy over a 2-week period (iTCBT-Enhanced). These sessions will identify areas where participants might benefit from more in-depth focus on specific concepts taught in the treatment.
iTCBT-G
Group format over 2 days
Treatment as Usual (TAU)
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual, which may include other forms of psychotherapy and/or medication.
TAU
Standard care
Interventions
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iTCBT-I
Individual format over 2 weeks
iTCBT-G
Group format over 2 days
TAU
Standard care
Eligibility Criteria
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Inclusion Criteria
* Current diagnosis of at least one anxiety-based disorder: Posttraumatic Stress Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, Other Specified Trauma- and Stressor-Related Disorder, Other Specified Anxiety Disorder, and Unspecified Anxiety Disorder (based on ADIS-5)
* Moderate-to-poor life enjoyment and satisfaction as indicated by a score of 47 or lower on the QLES-Q-SF
* Stable on psychotropic medication for 4 weeks before study participation
* Willing to be randomized to treatment condition
Exclusion Criteria
* Depression with active suicidal ideation and intent that would preclude treatment (based on ADIS-5 \& BDI-II)
* Moderate-to-severe cognitive impairment as indicated by the SLUMS (a score below 20)
* Veterans/Service Members with comorbid substance/alcohol use or dependence are study eligible but must agree to reduce and limit their use of substances during the active course of treatment, particularly during exposure exercises. If they do not agree to this, they will be excluded
* Undergoing concurrent transdiagnostic CBT specifically targeting any of the above-mentioned disorders
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Baylor College of Medicine
OTHER
Responsible Party
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Ellen Teng
Principal Investigator
Principal Investigators
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Ellen Teng, PhD
Role: PRINCIPAL_INVESTIGATOR
Michael E. DeBakey VA Medical Center
Locations
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Michael E. DeBakey VA Medical Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Ellen Teng, PhD
Role: primary
Keri Bayley, PhD
Role: backup
Cynthia Kraus Schuman, PhD
Role: backup
Nicole Trapp, PhD
Role: backup
Terri Fletcher, PhD
Role: backup
Caitlin Clark, PhD
Role: backup
Other Identifiers
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H-52390
Identifier Type: -
Identifier Source: org_study_id