Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention

NCT04572750 | Completed Results

• 1 other identifier: IIR 18-026
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Benzodiazepines (e.g., Ativan, Xanax) are widely prescribed medications that are used mainly to treat anxiety and sleeping difficulties. Long-term use of benzodiazepine carries risks of physical dependence, addiction, falls and other accidents, and problems in thinking/concentrating. Researchers in Canada developed a printed self-help packet that enabled many individuals to reduce or cease taking benzodiazepines on their own. This study is designed to tailor that packet to the Veteran population, convert it to an app that people can use on their laptop or smart phone, and test whether the app helps promote benzodiazepine prescribing.

Conditions

Taking Benzodiazepines for Any Reason for 3 Months; Benzodiazepine Dependence

Keywords

insomnia; anxiety; benzodiazepine; self-help; patient education; electronic intervention

Outcome Measures

Primary Outcomes (2)

• 25% Reduction in Benzodiazepine Use

  This outcome reflects an individual cutting their dose of benzodiazepine medication by one quarter or more

  6 months

• Cessation of Benzodiazepine Use

  This outcome reflects an individual eliminating their benzodiazepine use from baseline to 6 month follow-up

  6 Months

Secondary Outcomes (3)

• Anxiety

  Baseline, 6 months

• Sleep Quality

  Baseline, 6 months

• Overall Health and Quality of Life

  Baseline, 6 months

Study Arms (2)

EMPOWER-ED

EXPERIMENTAL

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

Behavioral: EMPOWER-ED

Control

NO INTERVENTION

Individuals will be provided care as usual

Interventions

EMPOWER-ED BEHAVIORAL

An electronic app that runs on a variety of platforms and provides education and tools designed to promote self-driven reduction of benzodiazepines.

EMPOWER-ED

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans having a VA primary care provider and taking prescribed benzodiazepines for at least 3 months
• Have access to a smartphone, tablet, or computer

You may not qualify if:

• Individuals diagnosed with schizophrenia, dementia, seizure disorder, and/or spinal cord injury
• Individuals receiving palliative care

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Related Publications (3)

• Cucciare MA, Abraham TH, Kemp L, White P, Marchant K, Hagedorn HJ, Humphreys K. 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. J Med Internet Res. 2022 Sep 19;24(9):e35514. doi: 10.2196/35514.

  PMID: 36121697 RESULT

• Cucciare MA, Hagedorn HJ, Bounthavong M, Abraham TH, Greene CJ, Han X, Kemp L, Marchant K, White P, Humphreys K. Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention (EMPOWER-ED): Randomized controlled trial protocol. Contemp Clin Trials Commun. 2022 Sep 5;29:100994. doi: 10.1016/j.conctc.2022.100994. eCollection 2022 Oct.

  PMID: 36111174 RESULT

• Humphreys K, Hagedorn H, Han X, Kemp L, Poitra N, Cucciare MA. Electronic Intervention for Patient-Managed Benzodiazepine Tapering: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2551807. doi: 10.1001/jamanetworkopen.2025.51807.

  PMID: 41533380 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Keith Humphreys, PhD
• Organization: VA Palo Alto Health Care System

keith.humphreys@va.gov

(650) 493-5000

Study Officials

• Keith N. Humphreys, PhD MA

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

• Michael A Cucciare, PhD

  Central Arkansas Veterans Healthcare System , Little Rock, AR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: At follow-up interview, the interviewer will no know whether the individual was in the treatment or control condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The EMPOWER-ED intervention is an app that runs on a smart phone or computer. It will provide education about the risk of benzodiazepine, a tool to create a method of self-tapering, and information on how to succeed at reducing or quitting benzodiazepine use. Individuals in the treatment condition of the trial will be given access to EMPOWER-ED on any platform they wish to use.

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: October 1, 2020
• Study Start: June 1, 2022
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: January 23, 2026
• Results First Posted: May 23, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)