EMPOWER-ED App for Benzodiazepine Withdrawal

(EMPOWER-ED Trial)

Overseen By Michael A Cucciare, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Benzodiazepines

Disqualifiers: Schizophrenia, Dementia, Seizure disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist veterans who wish to reduce or stop using benzodiazepines, medications commonly prescribed for anxiety and sleep issues. The study will test a new app called EMPOWER-ED, which builds on a successful self-help packet and allows users to access it on smartphones or computers. Participants will either use this app or continue their usual care. Veterans who have been taking benzodiazepines for at least three months and have access to a digital device are suitable candidates for this study. As an unphased trial, this study provides veterans with a unique opportunity to explore innovative digital solutions for managing benzodiazepine use.

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

The trial focuses on helping participants reduce or stop taking benzodiazepines, so you may need to change how you take these medications. The protocol does not specify about other medications.

What prior data suggests that the EMPOWER-ED app is safe for benzodiazepine withdrawal?

Research has shown that the EMPOWER approach, which forms the basis of the EMPOWER-ED app, is effective and safe. Although specific safety data for the EMPOWER-ED app is not available, the original printed self-help materials have not revealed any major issues. This suggests that the app, which aids in reducing benzodiazepine use, is likely safe.

Stopping or reducing benzodiazepines can sometimes cause withdrawal symptoms. However, the app is designed to help manage this process safely. Always consult a healthcare provider before changing medication usage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The EMPOWER-ED app is unique because it offers a digital, self-help approach to benzodiazepine withdrawal, which is typically managed with gradual dose reduction and possibly supportive medications. This app stands out as it empowers individuals to take control of their withdrawal process through a platform of their choice, making the support more accessible and personalized. Researchers are excited about this treatment because it leverages technology to provide an innovative, scalable solution that could enhance adherence and success rates in reducing benzodiazepine use.

What evidence suggests that the EMPOWER-ED app is effective for benzodiazepine withdrawal?

Research has shown that the original EMPOWER self-help packet made individuals eight times more likely to stop or reduce their use of benzodiazepines, such as Ativan and Xanax, which treat anxiety. This indicates that those using EMPOWER were significantly more successful in cutting back or quitting these medications compared to those who did not use it. In this trial, participants in the experimental arm will use the EMPOWER-ED app, which builds on this successful packet and aims to help veterans reduce or stop using these anxiety medications. The app is easy to use on a phone or computer, making it accessible to many. This suggests it could be a valuable tool for those seeking to cut back on benzodiazepines. ^{1 2 5 6 7}

Who Is on the Research Team?

Keith N. Humphreys, PhD MA

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Michael A Cucciare, PhD

Principal Investigator

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Are You a Good Fit for This Trial?

This trial is for veterans who have been prescribed benzodiazepines (like Ativan or Xanax) for at least 3 months and have a VA primary care provider. Participants must be able to use a smartphone, tablet, or computer. It's not open to individuals with schizophrenia, dementia, seizure disorders, spinal cord injuries, or those receiving palliative care.

Inclusion Criteria

Have access to a smartphone, tablet, or computer

I am a veteran with a VA primary care provider and have been prescribed benzodiazepines for over 3 months.

Exclusion Criteria

I have been diagnosed with a seizure disorder.

I am receiving care focused on relieving symptoms.

Individuals diagnosed with schizophrenia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Tailoring and converting the EMPOWER intervention to an electronic format for Veterans

Not specified

Treatment

Participants use the EMPOWER-ED app to reduce benzodiazepine use

6 months

App usage (self-directed)

Follow-up

Participants are monitored for benzodiazepine cessation and reduction, anxiety, sleep quality, and overall health

6 months

Long-term Follow-up

Evaluation of long-term benzodiazepine reduction and cessation using VA databases

12 months

What Are the Treatments Tested in This Trial?

Interventions

• EMPOWER-ED

Trial Overview The study tests an app called EMPOWER-ED designed to help veterans reduce or stop using benzodiazepines. The app is based on a self-help packet that has previously helped people quit these medications. Veterans will use the app on their devices as part of the intervention.

How Is the Trial Designed?

Group I: EMPOWER-ED Experimental Treatment 1 Intervention

Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use

Group II: Control Active Control 1 Intervention

Individuals will be provided care as usual

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. withpower.com withpower.com/trial/phase-7-2021-b8a9b

EMPOWER-ED App for Benzodiazepine Withdrawal This trial tests an app called EMPOWER-ED designed to help Veterans reduce or stop using anxiety medications like Ativan and Xanax.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9468353/

Randomized controlled trial protocol The original EMPOWER study reported an eight-fold difference in benzodiazepine cessation and reduction rates, which converts to a Cohen's d greater than 0.8 [19] ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04572750

Study Details | NCT04572750 | Promoting Benzodiazepine ... ... EMPOWER was shown effective in a non-VA clinical trial, and ... app focused on reducing benzodiazepine use. Intervention/Treatment, Behavioral : EMPOWER-ED.

4. sciencedirect.com sciencedirect.com/org/science/article/pii/S1438887122006021

Focus Group Study With US Military Veterans and National ... EMPOWER-ED is the first direct-to-patient electronically delivered protocol designed to help US military veterans self-taper from long-term benzodiazepine use.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36111174/

Randomized controlled trial protocol Measurements: The primary outcomes are complete benzodiazepine cessation and 25% dose reduction, assessed using administrative and self-report ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2813161

Benzodiazepine Discontinuation and Mortality Among ... This study identifies small absolute increases in risk of harms among patients with stable long-term prescription benzodiazepine treatment who appear to ...

7. jmir.org jmir.org/2022/9/e35514/

Focus Group Study With US Military Veterans and National ... EMPOWER-ED is the first direct-to-patient electronically delivered protocol designed to help US military veterans self-taper from long-term benzodiazepine use.