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Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Anxiety
N/A
Waitlist Available
Led By Terri L. Fletcher, PhD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4-, 8-, and 12-month
Awards & highlights
Study Summary
This trial will study whether a type of cognitive behavioral therapy is helpful for Veterans with anxiety and worry, delivered either in-person or by video telehealth.
Who is the study for?
This trial is for U.S. military Veterans experiencing significant anxiety, who are currently receiving or eligible for mental health services at the Houston, New Orleans, or San Antonio VA Medical Centers. They must have consistent symptoms of anxiety confirmed by screenings and not be in psychotherapy for anxiety already. Those with bipolar, psychotic disorders, substance abuse issues, or cognitive impairments cannot join.Check my eligibility
What is being tested?
The study tests a brief form of Cognitive Behavioral Therapy (CBT) to treat anxiety in Veterans. It compares this treatment's effectiveness when done face-to-face versus via video telehealth against usual care methods. The impact of daily discrimination on therapy outcomes will also be assessed.See study design
What are the potential side effects?
While CBT typically has no direct physical side effects as it's a talking therapy, participants may experience temporary increases in distress as they confront and work through their anxieties during sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4-, 8-, and 12-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4-, 8-, and 12-month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
GAD-7 Change
Secondary outcome measures
OASIS Change
SF-12 Change
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Brief Cognitive Behavioral TherapyExperimental Treatment1 Intervention
The proposed bCBT treatment for anxiety was specifically designed for use within VA PCMHI settings and uses a patient-centered approach to increase engagement while addressing the mental health needs of anxious Veterans. Emphasis was placed on maximizing intervention potency and minimizing intensity and duration to improve implementation value and alignment with VA PCMHI requirements. The intervention directly addresses challenges to delivery of CBT providing 1) a brief, practical model of care to address multiple anxiety conditions consistent with the PCMHI model (e.g. 4-6 sessions; measurement-based care), and 2) a clinically potent intervention that includes exposure-based skills.
Group II: Enhanced Usual CareActive Control1 Intervention
EUC participants will receive anxiety education materials, a note in their medical record indicating the presence of elevated anxiety symptoms, and 4 brief monthly check-in calls with project staff. The primary outcome, anxiety symptoms, will be evaluated at 4-, 8- and 12-month follow-ups. Due to ethical concerns of withholding needed treatment, EUC participants will NOT be restricted from receiving mental health services including psychotherapy during the study period. The investigators fully expect that EUC participants may receive anxiety treatments (e.g., antianxiety and antidepressant medications or psychotherapy).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brief Cognitive Behavioral Therapy
2007
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,378 Total Patients Enrolled
17 Trials studying Anxiety
1,861 Patients Enrolled for Anxiety
Terri L. Fletcher, PhDPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX
1 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently in psychotherapy for anxiety.Participants who are veterans will currently be receiving services from the Houston, New Orleans, or San Antonio Veteran Affairs Medical Centers.You have been diagnosed with bipolar disorder, psychotic disorder, or substance abuse disorder.I am a veteran with consistent anxiety symptoms, confirmed by two tests.will have their information shared with their PCMHI providerI have difficulty with memory or thinking clearly.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Usual Care
- Group 2: Brief Cognitive Behavioral 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are currently taking part in this clinical experiment?
"Affirmative, the information available on clinicaltrials.gov shows that this research is currently enrolling participants. Initially posted on March 1st 2022 and last revised a week later, the trial seeks to enrol 225 patients from 3 distinct medical centres."
Answered by AI
Are fresh participants being sought for this research project?
"According to information on clinicaltrials.gov, this trial is currently recruiting participants and was initially posted on March 1st 2022 with the most recent update being October 1st 2022."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Michael E. DeBakey VA Medical Center, Houston, TX
What portion of applicants met pre-screening criteria?
Did not meet criteria
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