Anxiety Disorders Clinical Trial
Official title:
Enhancing Intensive Transdiagnostic Cognitive Behavioral Therapy for Veterans With PTSD and Anxiety Disorders
The goal of this clinical trial is to compare two different intensive formats of delivering cognitive-behavioral treatment for people with PTSD and anxiety disorders. The main questions it aims to answer are: - 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.
Status | Recruiting |
Enrollment | 306 |
Est. completion date | September 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Veteran/Service Member at least 18 years old - 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: - Active symptoms of mania or psychosis at baseline (based on ADIS-5) - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Michael E. DeBakey VA Medical Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Quality of Life score on the Quality of Life Enjoyment & Satisfaction Questionnaire Short-Form (QLES-Q-SF) from Baseline to 6-Month Follow-Up between the iTCBT conditions (Individual & Group) and TAU. | The QLES-Q-SF measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction and functioning. | 6-Month Follow-Up | |
Primary | Change in Anxiety score on the Beck Anxiety Inventory (BAI) from Baseline to 6-Month Follow-Up between the iTCBT conditions (Individual & Group) and TAU. | The BAI assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. Two components of anxiety are measured: The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0-63, with higher scores reflecting higher levels of anxiety. | 6-Month Follow-Up | |
Primary | Change in Quality of Life score on the Quality of Life Enjoyment & Satisfaction Questionnaire Short-Form (QLES-Q-SF) from Baseline to 6-Month Follow-Up between the iTCBT Enhanced (iTCBT-E) condition and TAU. | The QLES-Q-SF measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction and functioning. | 6-Month Follow-Up | |
Primary | Change in Anxiety score on the Beck Anxiety Inventory (BAI) from Baseline to 6-Month Follow-Up between the iTCBT Enhanced (iTCBT-E) condition and TAU. | The BAI assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. Two components of anxiety are measured: The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0-63, with higher scores reflecting higher levels of anxiety. | 6-Month Follow-Up | |
Secondary | Magnitude of Change in Quality of Life score on Quality of Life Enjoyment & Satisfaction Questionnaire Short-Form (QLES-Q-SF) from Baseline to 3- and 6-Month Follow-Ups between the iTCBT Individual and Group Conditions. | The QLES-Q-SF measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction and functioning. | 3- and 6-Month Follow-Ups | |
Secondary | Magnitude of Change in Anxiety score on the Beck Anxiety Inventory (BAI) from Baseline to 3- and 6-Month Follow-Ups between the iTCBT Individual and Group Conditions. | The BAI assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. Two components of anxiety are measured: The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0-63, with higher scores reflecting higher levels of anxiety. | 3- and 6-Month Follow-Ups |
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