NCT04572750: EMPOWER-ED

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

Completed NA Results posted Last updated 23 January 2026

What this trial tests

NA trial testing EMPOWER-ED in Taking Benzodiazepines for Any Reason for 3 Months in 170 participants. Completed in 3 July 2024.

Timeline

1 June 2022

Primary endpoint
3 July 2024

3 July 2024

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	170
Start date	1 June 2022
Primary completion	3 July 2024
Estimated completion	3 July 2024
Sites	1 location across United States

Drugs / interventions tested

• EMPOWER-ED

Conditions studied

• Taking Benzodiazepines for Any Reason for 3 Months — all drugs for Taking Benzodiazepines for Any Reason for 3 Months →
• Benzodiazepine Dependence — all drugs for Benzodiazepine Dependence →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Eligibility, any sex, with Taking Benzodiazepines for Any Reason for 3 Months or Benzodiazepine Dependence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

25% Reduction in Benzodiazepine Use Primary · 6 months

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

Group	Value	95% CI
EMPOWER-ED	14
Control	6

Cessation of Benzodiazepine Use Primary · 6 Months

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

Group	Value	95% CI
EMPOWER-ED	10
Control	2

Anxiety Secondary · Baseline, 6 months

Anxiety at baseline and 6-month follow-up will be measured using Spitzer's 7 item generalized anxiety disorder subscale. The minimum and the maximum of the measure are 0 and 21 respectively with higher score representing anxiety symptoms occurred more frequently.

baseline

Group	Value	95% CI
EMPOWER-ED	9.77	± 9.17
Control	8.86	± 8.81

follow-up

Group	Value	95% CI
EMPOWER-ED	8.23	± 6.60
Control	7.26	± 6.33

Sleep Quality Secondary · Baseline, 6 months

This outcome measures sleep quality as assessed by the Patient-Reporter Outcomes Measurement System. The minimum and the maximum of the measure are 8 and 40 respectively with higher score representing worse quality of sleep.

baseline

Group	Value	95% CI
EMPOWER-ED	23.84	± 12.02
Control	24.53	± 13.87

6-month follow-up

Group	Value	95% CI
EMPOWER-ED	23.80	± 8.54
Control	23.64	± 7.86

Overall Health and Quality of Life Secondary · Baseline, 6 months

Overall health and quality of life (Physical Component Summary and Mental Component Summary) will be assessed using the RAND Veterans SF-12. The minimum and the maximum of the physical component summary measure are 8.66 and 64.91 respectively with higher score representing better physical functioning. The minimum and the maximum of the mental component summary measure are 14.91 and 70.61 respectively with higher score representing better mental functioning.

Baseline Physical Component Summary

Group	Value	95% CI
EMPOWER-ED	38.06	± 15.84
Control	38.03	± 19.07

Follow-up Physical Component Summary

Group	Value	95% CI
EMPOWER-ED	37.45	± 10.77
Control	37.26	± 13.03

Baseline Mental Component Summary

Group	Value	95% CI
EMPOWER-ED	40.19	± 18.99
Control	40.21	± 17.25

Follow-up Mental Component Summary

Group	Value	95% CI
EMPOWER-ED	40.65	± 11.64
Control	41.27	± 10.24

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention (EMPOWER-ED): Randomized controlled trial protocol.
   Cucciare MA, Hagedorn HJ, Bounthavong M, Abraham TH, et al · · 2022 · cited 2× · PMID 36111174 · DOI 10.1016/j.conctc.2022.100994
2. Electronic Intervention for Patient-Managed Benzodiazepine Tapering: A Randomized Clinical Trial.
   Humphreys K, Hagedorn H, Han X, Kemp L, et al · · 2026 · PMID 41533380 · DOI 10.1001/jamanetworkopen.2025.51807