Cognitive Behavioral Therapy for Anxiety

Not currently recruiting at 2 trial locations

Overseen By Terri L. Fletcher, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Bipolar, Psychotic, Substance-abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4-6 sessions

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a brief cognitive behavioral therapy (CBT) to help Veterans with anxiety and worry, comparing it to the standard care typically received. The therapy can be conducted in person or through video calls, providing flexibility and accessibility. Veterans currently using services at the Houston, New Orleans, or San Antonio VA centers who exhibit noticeable anxiety symptoms might be suitable candidates. Additionally, the study will examine how daily experiences of discrimination affect participants. As an unphased trial, this study offers Veterans a unique opportunity to access potentially beneficial therapy while contributing to valuable research.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently receiving psychotherapy for anxiety, you will not be eligible to participate.

What prior data suggests that this cognitive behavioral therapy is safe for Veterans with anxiety?

Research has shown that cognitive behavioral therapy (CBT) is a well-known treatment for anxiety and stress-related issues. It effectively helps change unhelpful thoughts and feelings. Studies have found that CBT can improve anxiety and depression symptoms, although these improvements are sometimes described as small.

The version of CBT under study is brief and designed to fit into busy schedules, aiming to be effective in just a few sessions. Previous research on similar short CBT programs suggests they can work well, with benefits lasting even a year after treatment.

CBT is safe because it is non-invasive, meaning it doesn't involve surgery or medication. This makes it generally safe with few risks. Some people might feel uncomfortable discussing their anxiety, but this is a normal part of therapy. Overall, CBT is well-tolerated and has a strong safety record for managing anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Brief Cognitive Behavioral Therapy (bCBT) for anxiety because it offers a unique approach tailored for Veterans, especially within VA settings. Unlike standard treatments like traditional CBT, which can be lengthy, bCBT is designed to be brief and practical, typically involving just 4-6 sessions. This makes it more accessible and easier to fit into patients' schedules. Additionally, bCBT incorporates exposure-based skills to effectively tackle various anxiety conditions, enhancing its potency while maintaining a focus on patient-centered care. This targeted, efficient model could revolutionize how anxiety is managed, particularly in settings that require a streamlined yet effective approach.

What evidence suggests that this brief cognitive behavioral therapy is effective for anxiety?

Studies have shown that Cognitive Behavioral Therapy (CBT) effectively treats anxiety. Research indicates that many individuals with moderate to severe anxiety experience significant symptom reduction after CBT. In this trial, participants may receive a shorter version of CBT, called brief CBT (bCBT), which has shown promise in improving anxiety and related symptoms. Another trial confirmed CBT's strong ability to reduce anxiety and stress. Overall, research strongly supports CBT as a treatment for anxiety disorders. ^{3 6 7 8 9}

Who Is on the Research Team?

Terri L. Fletcher, PhD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants who are veterans will currently be receiving services from the Houston, New Orleans, or San Antonio Veteran Affairs Medical Centers.

Veterans with clinically significant symptoms of anxiety will be included after screening on two occasions to ensure consistency of anxiety symptoms (GAD-7 score of 10 or greater; telephone screen and baseline appointment)

Veteran participants will be current recipients of services at the Houston, New Orleans, or San Antonio VA Medical Centers

Exclusion Criteria

I am not currently in psychotherapy for anxiety.

You have been diagnosed with bipolar disorder, psychotic disorder, or substance abuse disorder.

I have difficulty with memory or thinking clearly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brief cognitive behavioral therapy (bCBT) for anxiety, delivered either in-person or via video telehealth

4-6 sessions

Sessions delivered in-person or via telehealth

Follow-up

Participants are monitored for anxiety symptoms using GAD-7 at 4-, 8-, and 12-month intervals

12 months

Follow-up assessments at 4, 8, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Brief Cognitive Behavioral Therapy

Trial Overview

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.

How Is the Trial Designed?

Group I: Brief Cognitive Behavioral Therapy Experimental Treatment 1 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 Care Active Control 1 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).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a systematic review of 19 randomized controlled trials involving 2188 participants, 10% of those undergoing cognitive behavior therapy (CBT) for health anxiety reported adverse events, and 17% dropped out of the treatment, indicating that while CBT is effective, it can have unwanted outcomes.

In a secondary study of 336 participants, 17% reported adverse events, and 0-10% experienced overall symptom deterioration, suggesting that while CBT is generally effective, there is variability in individual experiences and a need for strategies to minimize dropouts and adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unwanted outcomes in cognitive behavior therapy for pathological health anxiety: a systematic review and a secondary original study of two randomized controlled trials. Axelsson, E., Hedman-Lagerlöf, E.[2023]

A study involving seven patients with social anxiety disorder showed that a brief cognitive behavior therapy (CBT) program of six sessions effectively reduced social anxiety symptoms in all participants.

While brief CBT improved overall social anxiety and self-consciousness, it did not significantly reduce fear of negative evaluation for all patients, indicating that some individuals may require longer treatment for deeper cognitive changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief cognitive behavior therapy in patients with social anxiety disorder: a preliminary investigation. Pinjarkar, RG., Sudhir, PM., Math, SB.[2020]

In a feasibility study involving 14 patients, an intensive version of Cognitive Therapy for PTSD (CT-PTSD) was well tolerated, with 85.7% of participants no longer meeting the criteria for PTSD after treatment.

Intensive CT-PTSD not only achieved similar outcomes to traditional weekly therapy but also resulted in faster symptom improvement and greater reductions in depression, suggesting it could be a promising alternative for treating PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive cognitive therapy for PTSD: a feasibility study. Ehlers, A., Clark, DM., Hackmann, A., et al.[2022]

Citations

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Social anxiety outcomes continue to improve 12 months or longer after CBT treatment. •. Moderate gains in general anxiety and depressive symptoms after CBT ...