Anxiety Skills Training for Anxiety

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

177 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment PCMHI Usual Care, Veterans Anxiety Skills Training Intervention for anxiety?

Research shows that skills training programs, like the five-session STAIR, can significantly improve symptoms of PTSD, depression, and social functioning in veterans. Additionally, intensive coping skills training has been effective in reducing anxiety and depression among forward-deployed troops, suggesting that similar skills-based interventions may help veterans manage anxiety. ^{1 2 3 4 5}

Is Anxiety Skills Training for Anxiety safe for humans?

The research articles provided do not contain specific safety data for Anxiety Skills Training for Anxiety or its related interventions. However, they discuss safety behaviors and their role in anxiety treatments, suggesting that safety information can help reduce anxiety without adverse effects. ^{6 7 8 9 10}

How is the Veterans Anxiety Skills Training Intervention different from other anxiety treatments?

The Veterans Anxiety Skills Training Intervention is unique because it is a video-delivered program specifically designed for older veterans, combining psychoeducation, diaphragmatic breathing, and progressive muscle relaxation to be accessible at home, unlike traditional in-person therapies. ^{11 12 13 14 15}

What is the purpose of this trial?

Anxiety symptoms are common among primary care patients, but anxiety is undertreated. Brief behavioral (non-medication) anxiety treatments are needed. 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 impairment in Veterans compared to usual care. The brief anxiety treatment, Veterans Anxiety Skills Training (VAST), was designed to be evidence-based (emphasis on cognitive-behavioral skills), transdiagnostic (applicable to a wide range of anxiety symptoms), feasible for integrated primary care (no more than 6 brief \[30-minute\] sessions), and Veteran-centered (tailored to Veterans and personalized to individual patients). A total of 170 adult Veteran primary care patients from the Syracuse and Western New York VA healthcare systems who are experiencing anxiety symptoms will be recruited and randomly assigned to receive the brief anxiety treatment or usual care. The investigators will compare anxiety symptom severity and functional impairment between the two groups at baseline and at post-assessment (at 16 weeks) and follow-up assessment (at 28 weeks). The investigators will also examine predictors of treatment response among those receiving VAST and whether providers deliver VAST as intended.

Research Team

Robyn L. Shepardson, PhD

Principal Investigator

Syracuse VA Medical Center, Syracuse, NY

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Examining the nonresponse phenomenon: Factors associated with treatment response in a national sample of veterans undergoing residential PTSD treatment. [2020]

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

A Randomized Controlled Trial of Brief Skills Training in Affective and Interpersonal Regulation (STAIR) for Veterans in Primary Care. [2021]

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

Treating comorbid panic disorder in veterans with posttraumatic stress disorder. [2018]

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

Intensive coping skills training to reduce anxiety and depression for forward-deployed troops. [2019]

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

Iraq and Afghanistan veterans: national findings from VA residential treatment programs. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Characterizing human safety learning via Pavlovian conditioned inhibition. [2021]

7. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the judicious use of safety behaviors during exposure therapy. [2020]

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

Differential effects of safety in extinction of anxious responding to a CO2 challenge in patients with panic disorder. [2015]

9. England pubmed.ncbi.nlm.nih.gov

The effects of safety behavior availability versus utilization on inhibitory learning during exposure. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Reducing safety behaviors to prevent anxious symptoms: a pre-registered prevention intervention study. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Development of a video-delivered relaxation treatment of late-life anxiety for veterans. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Relaxation training for anxiety: a ten-years systematic review with meta-analysis. [2022]

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

The use of stress inoculation training in the reduction of public speaking anxiety. [2019]

14. Canada pubmed.ncbi.nlm.nih.gov

Adapting Coordinated Anxiety Learning and Management for Veterans Affairs Community-Based Outpatient Clinics: Iterative Approach. [2020]

15. England pubmed.ncbi.nlm.nih.gov

Factors Affecting Adoption of Coordinated Anxiety Learning and Management (CALM) in Veterans' Affairs Community-Based Outpatient Clinics. [2021]