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Behavioral Intervention
Group Cognitive Behavioral 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 be clearly competent to provide informed consent for research participation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to week 6 to week 12 to 6-month followup
Awards & highlights
Study Summary
This trial will compare the efficacy of group transdiagnostic behavior therapy (G-TBT) to group cognitive behavioral therapy (G-CBT) and group cognitive processing therapy (G-CPT) in Veterans Affairs Medical Center (VAMC) patients with major depressive disorder and PTSD.
Who is the study for?
This trial is for Veterans enrolled at the Charleston VAMC with a major diagnosis of depression or PTSD. They must be able to consent and not have severe illnesses, recent hospitalizations for mental health, substance use disorders, new psychiatric meds in the last month, TBI symptoms, schizophrenia, psychotic symptoms, personality disorder or bipolar disorder.Check my eligibility
What is being tested?
The study compares Group Transdiagnostic Behavior Therapy (G-TBT), which treats various disorders within one protocol against specific group therapies for depression and PTSD. It aims to improve accessibility and outcomes of CBT treatments within Veteran Affairs Medical Centers.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects from cognitive behavioral therapy can include discomfort discussing past traumas or emotions during sessions but typically do not involve physical side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand and can consent to participate in research.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Depression Anxiety Stress Scale (DASS-Depression)
Illness Intrusiveness Ratings Scale (IIRS)
PTSD Checklist for DSM-5 (PCL-5)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 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. Per protocol, the first six sessions of TBT are designed to educate on, prepare for, and practice the four different types of exposure techniques. The next five sessions are focused on practicing and refining exposure practices as participants work through their lists of avoided situations/sensation/thoughts. The final session reviews treatment progress and relapse prevention strategies.
Group II: Group Disorder-Specific Therapy (G-DSTs)Active Control1 Intervention
To provide an evidence-based comparison for the G-TBT condition, G-DSTs will be used that are matched to the participant?s principal diagnosis. G-DSTs will include groups for the most common principal diagnoses that have VA-approved protocols and training programs, including PTSD (Cognitive Processing Therapy for PTSD) and MDD (CBT-Depression). Each of these G-DSTs have published manuals for administration and have received extensive support in the literature.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Group Transdiagnostic Behavior Therapy
2021
N/A
~300
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,309 Total Patients Enrolled
Daniel F Gros, PhD MA BSPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
3 Previous Clinical Trials
585 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I started a new psychiatric medication less than 4 weeks ago.You have been diagnosed with either major depressive disorder or posttraumatic stress disorder according to specific guidelines.I have been diagnosed with schizophrenia, bipolar disorder, or a personality disorder.I have been diagnosed with a traumatic brain injury or have symptoms of it.I do not have a severe illness that would interfere with the study.I understand and can consent to participate in research.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group Disorder-Specific Therapy (G-DSTs)
- Group 2: Group Transdiagnostic Behavior Therapy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is participation in this experiment widespread?
"Affirmative. The information available on clinicaltrials.gov conveys that this experiment is in the process of recruiting participants, with its posting date being February 3rd 2021 and last update taking place January 10th 2022. 208 individuals will be accepted at a single site for participation."
Answered by AI
Is this investigation seeking out adults above the age of majority?
"This medical experiment is open to participants aged 18 or above and under the age of 80."
Answered by AI
Does this trial have any eligibility criteria?
"To be eligible for the trial, it is necessary that patients have a qualifying disorder and are aged between 18-80. The researcher's aim to enrol 208 people in total."
Answered by AI
Are there still opportunities for participants to join this research endeavor?
"As per the data hosted on clinicaltrials.gov, recruitment for this medical study is currently ongoing after being initially posted back in February 2021 and last updated in January 2022."
Answered by AI
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