Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaylor College of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
iTCBT-I
BehavioralIndividual format over 2 weeks
iTCBT-G
BehavioralGroup format over 2 days
TAU
BehavioralStandard care
Treatment groups
306 Participants
are divided into 3 treatment groupsGroup A: iTCBT-I (Intensive Transdiagnostic Cognitive Behavioral Therapy-Individual)Experimental treatment 1 intervention
Group B: iTCBT-G (Intensive Transdiagnostic Cognitive Behavioral Therapy-Group)Active comparator 1 intervention
Group C: Treatment as Usual (TAU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6-Month Follow-Up2
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.
Time frame
6-Month Follow-Up3
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.
Time frame
6-Month Follow-Up4
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.
Time frame
6-Month Follow-UpSecondary outcomes
1
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.
Time frame
3- and 6-Month Follow-Ups2
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.
Time frame
3- and 6-Month Follow-UpsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Baylor College of Medicine
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov