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

170 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests an app called EMPOWER-ED designed to help Veterans reduce or stop using anxiety medications like Ativan and Xanax. The app offers step-by-step support to taper off these drugs safely. Researchers hope it will improve health outcomes and reduce risks associated with long-term use of these medications.

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 data supports the effectiveness of the EMPOWER-ED treatment for benzodiazepine withdrawal?

The EMPOWER-ED treatment is based on a successful self-management intervention called EMPOWER, which was effective in helping older adults reduce or stop benzodiazepine use. This approach, originally delivered as a booklet, has shown promise in promoting benzodiazepine cessation and is now being adapted for electronic delivery to reach more people, including U.S. military veterans. ^{1 2 3 4 5}

Is the EMPOWER-ED app safe for humans?

The EMPOWER intervention, which the EMPOWER-ED app is based on, has been used safely in older adults to help reduce benzodiazepine use. There is no specific safety data for the EMPOWER-ED app itself, but the original EMPOWER approach has been effective without reported safety issues. ^{1 2 3 4 6}

How does the EMPOWER-ED treatment differ from other treatments for benzodiazepine withdrawal?

The EMPOWER-ED treatment is unique because it likely involves a digital or app-based approach to support benzodiazepine withdrawal, which is different from traditional methods that focus on gradual dosage reduction and psychological support. This app-based method may offer more accessible and flexible support for patients compared to in-person counseling or therapy. ^{4 5 7 8 9}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention (EMPOWER-ED): Randomized controlled trial protocol. [2022]

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

Use of the EMPOWER brochure to deprescribe sedative-hypnotic drugs in older adults with mild cognitive impairment. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

Adapting the Eliminating Medications Through Patient Ownership of End Results Protocol to Promote Benzodiazepine Cessation Among US Military Veterans: Focus Group Study With US Military Veterans and National Veterans Health Administration Leaders. [2022]

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

Effectiveness of current treatment approaches for benzodiazepine discontinuation: a meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

One-time counselling decreases the use of benzodiazepines and related drugs among community-dwelling older persons. [2014]

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

A consumer-targeted, pharmacist-led, educational intervention to reduce inappropriate medication use in community older adults (D-PRESCRIBE trial): study protocol for a cluster randomized controlled trial. [2022]

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

The treatment of benzodiazepine dependence. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Symptom-triggered therapy for assessment and management of alcohol withdrawal syndrome in the emergency department short-stay clinical decision unit. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Effects of flumazenil in the treatment of benzodiazepine withdrawal--a double-blind pilot study. [2019]