Anxiety Skills Training for Anxiety

No longer recruiting at 1 trial location

Overseen By Tessa Livingston, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Psychotropics

Disqualifiers: OCD, SMI, PTSD, severe depression, others

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

Compensation: Varies

Number of Visits: 7

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new anxiety treatment specifically designed for Veterans experiencing anxiety symptoms. The goal is to determine if a brief, non-medication therapy can reduce anxiety symptoms more effectively than regular care. Participants will either receive the new therapy, called the Veterans Anxiety Skills Training Intervention, which includes up to six 30-minute sessions focused on cognitive-behavioral skills, or continue with their usual care. Veterans who have visited a primary care clinic in Syracuse or Western New York in the past year and have experienced significant anxiety symptoms in the last two weeks may be suitable candidates for this study. As an unphased trial, this study offers Veterans a unique opportunity to access innovative therapy and contribute to research that could improve anxiety care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have started or changed the dosage of anxiety or depression medications in the past 30 days, you may not be eligible to participate.

What prior data suggests that the Veterans Anxiety Skills Training is safe for Veterans?

Research shows that cognitive-behavioral therapy (CBT), the foundation of the Veterans Anxiety Skills Training (VAST), is generally safe for treating anxiety. Studies have found that most people handle CBT well, experiencing few serious side effects. The main challenge often lies in maintaining commitment to the therapy, rather than encountering health problems.

In past studies, shorter versions of CBT, like the one used in VAST, successfully treated Veterans in primary care. These studies found that Veterans benefited from the treatment without significant negative effects. This suggests that the VAST program is safe and manageable for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Veterans Anxiety Skills Training Intervention because it offers a personalized approach to managing anxiety, specifically tailored for veterans. Unlike standard treatments, which often involve general therapy sessions or medication, this intervention uses a modular cognitive-behavioral strategy. This means it can be customized to fit each veteran's unique needs, potentially leading to more effective and faster relief from anxiety symptoms. By focusing on individual experiences and challenges, this intervention might empower veterans with practical skills that are directly applicable to their daily lives.

What evidence suggests that the Veterans Anxiety Skills Training Intervention is effective for reducing anxiety symptoms in Veterans?

Research has shown that therapies like the Veterans Anxiety Skills Training (VAST), which participants in this trial may receive, can help reduce anxiety. These therapies teach practical skills to manage stress and worry. The VAST program is specially designed for Veterans, addressing their specific needs with short sessions that fit into busy schedules. Early results suggest that Veterans prefer these tailored, evidence-based treatments, which can significantly improve anxiety symptoms. Another group in this trial will receive usual care anxiety treatment, serving as a control condition. ^{1 3 5 6 7}

Who Is on the Research Team?

Robyn L. Shepardson, PhD

Principal Investigator

Syracuse VA Medical Center, Syracuse, NY

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18 or older who have been seen at Syracuse or Western New York VA primary care clinics in the last year and are experiencing significant anxiety symptoms. It's not open to those with severe communication barriers, cognitive impairments that prevent informed consent, certain mental health diagnoses like OCD or SMI, current intensive psychotherapy for anxiety/depression, recent changes in psychotropic medications, severe depression, or PTSD.

Inclusion Criteria

Seen in the Syracuse or Western New York VAMC or CBOC primary care clinic in the past 12 months

I have significant anxiety symptoms recently.

Veteran

Exclusion Criteria

I was diagnosed with PTSD or screened positive for it in the last 2 years.

I am currently in therapy for anxiety or depression.

I have recently started or changed my anxiety or depression medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Veterans Anxiety Skills Training (VAST) intervention, consisting of up to six 30-minute sessions over 16 weeks

16 weeks

Up to 6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 28 weeks

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PCMHI Usual Care
• Veterans Anxiety Skills Training Intervention

Trial Overview The study compares a brief behavioral treatment called Veterans Anxiety Skills Training (VAST), which includes up to six 30-minute sessions focused on cognitive-behavioral skills tailored for Veterans' needs against usual care. The effectiveness of VAST will be measured by looking at the severity of anxiety symptoms and functional impairment before and after treatment.

How Is the Trial Designed?

Group I: Intervention condition Experimental Treatment 1 Intervention

Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans

Group II: Control condition Active Control 1 Intervention

Usual care anxiety treatment

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

A meta-analysis of 27 studies from 1997 to 2007 found that relaxation training, including techniques like meditation and progressive relaxation, has a medium to large effect size in reducing anxiety, with Cohen's d values of 0.57 and 0.51 for within and between group analyses, respectively.

The efficacy of relaxation training was found to be higher for meditation techniques, among volunteer participants, and in longer treatment durations, indicating that these factors can enhance the effectiveness of anxiety reduction strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relaxation training for anxiety: a ten-years systematic review with meta-analysis. Manzoni, GM., Pagnini, F., Castelnuovo, G., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10166236/

Brief, Modular, Transdiagnostic, Cognitive-Behavioral ... We developed a modular, cognitive-behavioral anxiety intervention, Modular Anxiety Skills Training (MAST), that is evidence-based, transdiagnostic, feasible ...

2. hsrd.research.va.gov hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141707459

IIR 18-233 – HSR Study - VA Health Systems Research Using a partnership approach, the project will examine the effectiveness and implementation potential of a brief psychotherapy program for Veterans with anxiety ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04829240

Brief Anxiety Skills Training Intervention for Veterans in ... The purpose of this study is to evaluate whether a brief anxiety treatment designed for VA primary care is more effective at reducing anxiety symptoms and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9358443/

Anxiety Treatment Preferences among Veteran Primary ... Our results suggest that mental health services provided through IPC models such as PCBH are consistent with many of Veterans' anxiety treatment preferences, ...

5. ctv.veeva.com ctv.veeva.com/study/brief-anxiety-skills-training-intervention-for-veterans-in-primary-care

Brief Anxiety Skills Training Intervention for Veterans in ... Background/Rationale: Many Veteran primary care patients experience impairing symptoms of anxiety, but rates of behavioral treatment are low.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9834105/

Efficacy of Cognitive Behavioral Therapy for Anxiety- ... Randomized controlled trials published in the last 5 years show relatively minimal advantage in CBT over psychological placebos in the treatment ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4479977/

Cognitive-behavioral Therapy for Late-life Anxiety Cognitive-behavioral therapy (CBT) is an evidence-based treatment for anxiety; however, a growing body of research suggests that CBT effect sizes are smaller ...