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Behavioral Intervention
Transdiagnostic Behavior Therapy for Depression and PTSD
N/A
Waitlist Available
Led By Daniel F Gros, PhD MA BS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must meet DSM-5 criteria for panic disorder, major depressive disorder, or posttraumatic stress disorder
Participants must be 18-80 years old
Must not have
acute, severe illness or medical condition that likely will require hospitalization and/or otherwise interfere with study procedures as documented in their medical record (e.g., active chemotherapy/radiation treatment for cancer)
diagnosis of moderate-to-severe traumatic brain injury in their medical record and/or endorsement of screener questionnaire
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to week 6 to week 12 to 6-month followup
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effectiveness of a new treatment, transdiagnostic behavior therapy (TBT), against existing treatments for veterans with major depressive disorder, posttraumatic stress disorder, and panic disorder.
Who is the study for?
This trial is for Veterans aged 18-80 with depression, PTSD, or panic disorder who can consent to research. It's not for those recently hospitalized for psychiatric reasons, have severe illnesses like active cancer treatment, or started new psychiatric meds in the last month.
What is being tested?
The study compares Transdiagnostic Behavior Therapy (TBT), a single protocol therapy designed to treat various disorders at once, with specific Cognitive Behavioral Therapies tailored individually for major depressive disorder (MDD), PTSD, and panic disorder.
What are the potential side effects?
While this trial involves psychological therapies rather than medications, participants may experience emotional discomfort discussing personal issues. Side effects are generally less severe than those associated with medication but can include increased anxiety or stress.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with panic disorder, major depression, or PTSD.
Select...
I am between 18 and 80 years old.
Select...
I understand and can agree to the study's requirements.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a severe illness that would require hospitalization or interfere with the study.
Select...
I have a moderate-to-severe traumatic brain injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to week 6 to week 12 to 6-month followup
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to week 6 to week 12 to 6-month followup
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PTSD Checklist for DSM-5 (PCL-5)
Panic Disorder Severity Scale (PDSS)
Patient Health Questionnaire - 9 (PHQ-9)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Transdiagnostic Behavior TherapyExperimental Treatment1 Intervention
TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
Group II: Disorder Specific TherapiesActive Control3 Interventions
To provide an evidence-based comparison for the TBT condition, DSTs will be used that are matched to the participant's most severe diagnosis, based upon the average of the ADIS interference and distress scores. If the scores are equivalent for two or more diagnoses, participants will be asked to list which diagnosis/symptoms that they find most impairing. DSTs will be included for each of the three targeted diagnoses, including PTSD (CPT for PTSD), PD/AG (CBT for PD/AG), and MDD (CBT for MDD). Each of these DSTs have published manuals for administration and have received extensive support in the literature (Barlow, 2014).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transdiagnostic Behavior Therapy
2014
N/A
~110
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,509 Total Patients Enrolled
Daniel F Gros, PhD MA BSPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
3 Previous Clinical Trials
663 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a severe illness that would require hospitalization or interfere with the study.I have been diagnosed with panic disorder, major depression, or PTSD.I started a new psychiatric medication less than 4 weeks ago.I am between 18 and 80 years old.I have a moderate-to-severe traumatic brain injury.You can have other mental health diagnoses as long as they are not the main reason for your participation in the study.I understand and can agree to the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Disorder Specific Therapies
- Group 2: Transdiagnostic Behavior Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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