Cognitive Behavioral Therapy for Anxiety

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

225 Participants Needed

Trial Summary

What is the purpose of this trial?

This 4-year study will examine the value of a type of a brief cognitive behavioral therapy treatment for Veterans with anxiety and worry. This treatment will be delivered either in-person, or by video telehealth to the Veteran's home. The treatment will be delivered by providers at three Veterans Administration Medical Centers (Houston, New Orleans, and San Antonio). The study will compare the helpfulness of this treatment to the usual care Veterans receive for anxiety and worry. A supplement to this study will also evaluate daily discrimination experiences of Veterans based on the participant's race, ethnicity, religion, physical appearance, or other characteristics.

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 data supports the effectiveness of the treatment Brief Cognitive Behavioral Therapy for anxiety?

Research shows that cognitive behavioral therapy (CBT) is effective for treating anxiety disorders, with patients experiencing significant improvement in anxiety symptoms. A large study found that patients receiving CBT showed reliable improvement in anxiety severity, quality of life, and functioning. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for humans?

Cognitive Behavioral Therapy (CBT) is generally considered safe for treating anxiety and other conditions, with no major safety concerns reported in the research. However, some studies mention that little is known about unwanted outcomes, suggesting that while it is safe, individual experiences may vary. ^{6 7 8 9 10}

How is Brief Cognitive Behavioral Therapy different from other treatments for anxiety?

Brief Cognitive Behavioral Therapy is unique because it offers a shorter, more intensive approach compared to traditional cognitive-behavioral therapy, which typically involves multiple sessions over several months. This brief version aims to improve treatment adherence by reducing the time commitment required from patients. ^{6 9 11 12 13}

Research Team

Terri L. Fletcher, PhD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Symptom improvement and its temporal course in short-term dynamic psychotherapy. A growth curve analysis. [2019]

2. England pubmed.ncbi.nlm.nih.gov

A meta-analytic review of the effects of psychotherapy control conditions for anxiety disorders. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

A meta-analysis of nonrandomized effectiveness studies on outpatient cognitive behavioral therapy for adult anxiety disorders. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Beyond the Constraints of an RCT: Naturalistic Treatment Outcomes for Anxiety-Related Disorders. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment Course Comparison Between Anxiety-Related Disorders in Adult Outpatients: A Leiden Routine Outcome Monitoring Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial for symptoms of anxiety and depression: Effects of a 1-day acceptance and commitment training workshop. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

When to recommend cognitive behavioral therapy. [2018]

8. England 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. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Is it Beneficial to Add Pharmacotherapy to Cognitive-Behavioral Therapy when Treating Anxiety Disorders? A Meta-Analytic Review. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for the treatment of anxiety disorders. [2018]

11. Israel pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy (CBT) in anxiety disorders. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Intensive cognitive therapy for PTSD: a feasibility study. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Brief cognitive behavior therapy in patients with social anxiety disorder: a preliminary investigation. [2020]