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Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety

Primary Purpose

Posttraumatic Stress Disorder, Anxiety Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iTCBT-I
iTCBT-G
TAU
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Anxiety, Veterans, Service Members, Reservists, Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Michael E. DeBakey VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

iTCBT-I (Intensive Transdiagnostic Cognitive Behavioral Therapy-Individual)

iTCBT-G (Intensive Transdiagnostic Cognitive Behavioral Therapy-Group)

Treatment as Usual (TAU)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 25, 2023
Last Updated
August 18, 2023
Sponsor
Baylor College of Medicine
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05843695
Brief Title
Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
Official Title
Enhancing Intensive Transdiagnostic Cognitive Behavioral Therapy for Veterans With PTSD and Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Anxiety disorders and posttraumatic stress disorder (PTSD) are among the leading mental health problems in the nation and are highly prevalent among service members and Veterans. The process of recovery and reintegration across the lifespan for military personnel with PTSD and anxiety disorders remains a significant problem. Due to the debilitating nature of these disorders, resuming and participating in major life roles following deployment can be challenging and often leads to avoidance of everyday activities and social withdrawal. Consequences of untreated anxiety-based disorders range from substantial impairment in social, vocational, emotional and physical functioning to high rates of suicide. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Anxiety Disorders
Keywords
PTSD, Anxiety, Veterans, Service Members, Reservists, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 treatment arms: iTCBT Individual; iTCBT Group; TAU
Masking
Outcomes Assessor
Masking Description
Assessors who conduct 3- and 6- months follow-up evaluations will be masked to participant treatment assignment.
Allocation
Randomized
Enrollment
306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iTCBT-I (Intensive Transdiagnostic Cognitive Behavioral Therapy-Individual)
Arm Type
Experimental
Arm Description
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.
Arm Title
iTCBT-G (Intensive Transdiagnostic Cognitive Behavioral Therapy-Group)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iTCBT-I
Intervention Description
Individual format over 2 weeks
Intervention Type
Behavioral
Intervention Name(s)
iTCBT-G
Intervention Description
Group format over 2 days
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
Standard care
Primary Outcome Measure Information:
Title
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.
Description
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-Up
Title
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.
Description
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-Up
Title
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.
Description
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-Up
Title
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.
Description
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-Up
Secondary Outcome Measure Information:
Title
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.
Description
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-Ups
Title
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.
Description
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-Ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Teng, PhD
Phone
(713) 791-1414
Ext
25513
Email
eteng@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Keri Bayley, PhD
Phone
(713) 791-1414
Ext
26419
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Teng, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Teng, PhD
Phone
713-791-1414
Ext
25513
Email
eteng@bcm.edu
First Name & Middle Initial & Last Name & Degree
Keri Bayley, PhD
Phone
(713) 791-1414
Ext
26419
First Name & Middle Initial & Last Name & Degree
Cynthia Kraus Schuman, PhD
First Name & Middle Initial & Last Name & Degree
Marilyn Hinojosa-Lindsey, PhD
First Name & Middle Initial & Last Name & Degree
Terri Fletcher, PhD
First Name & Middle Initial & Last Name & Degree
Caitlin Clark, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified, anonymized dataset containing itemized ratings from the psychological measures will be created and shared. Material will be made available electronically via Excel format and be accompanied by a Word format codebook describing variables in the dataset.
IPD Sharing Time Frame
Data requests can be submitted 12 months following manuscript publication.
IPD Sharing Access Criteria
Access to data from this clinical trial can be requested by qualified investigators conducting independent scientific research. Data will be provided via a data sharing agreement, following review and approval of a research proposal and analytic plan.

Learn more about this trial

Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety

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