Trial Outcomes & Findings for Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention (NCT NCT04572750)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

170 participants

Primary outcome timeframe

6 months

Results posted on

2026-01-23

Participant Flow

A total of 484 individuals were approach about the study, and 170 participants were enrolled. 244 individuals were not interested and 70 were ineligible.

Participant milestones

Participant milestones
Measure	EMPOWER-ED Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use	Control Individuals will be provided care as usual
Overall Study STARTED	85	85
Overall Study COMPLETED	82	79
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EMPOWER-ED n=82 Participants Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use	Control n=79 Participants Individuals will be provided care as usual	Total n=161 Participants Total of all reporting groups
Age, Continuous	62.28 years STANDARD_DEVIATION 13.58 • n=270 Participants	61.48 years STANDARD_DEVIATION 13.88 • n=4 Participants	61.89 years STANDARD_DEVIATION 13.69 • n=9 Participants
Sex: Female, Male Female	11 Participants n=270 Participants	16 Participants n=4 Participants	27 Participants n=9 Participants
Sex: Female, Male Male	71 Participants n=270 Participants	63 Participants n=4 Participants	134 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants	1 Participants n=4 Participants	1 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=270 Participants	0 Participants n=4 Participants	1 Participants n=9 Participants
Race (NIH/OMB) Black or African American	5 Participants n=270 Participants	6 Participants n=4 Participants	11 Participants n=9 Participants
Race (NIH/OMB) White	75 Participants n=270 Participants	68 Participants n=4 Participants	143 Participants n=9 Participants
Race (NIH/OMB) More than one race	1 Participants n=270 Participants	3 Participants n=4 Participants	4 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants	1 Participants n=4 Participants	1 Participants n=9 Participants

PRIMARY outcome

Timeframe: 6 months

Population: We excluded nine patients because they were not eligible.

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

Outcome measures

Outcome measures
Measure	EMPOWER-ED n=82 Participants Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use EMPOWER-ED: An electronic app that runs on a variety of platforms and provides education and tools designed to promote self-driven reduction of benzodiazepines.	Control n=79 Participants Individuals will be provided care as usual
25% Reduction in Benzodiazepine Use	14 Participants	6 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: We excluded nine subjects because they were not eligible.

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

Outcome measures

Outcome measures
Measure	EMPOWER-ED n=82 Participants Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use EMPOWER-ED: An electronic app that runs on a variety of platforms and provides education and tools designed to promote self-driven reduction of benzodiazepines.	Control n=79 Participants Individuals will be provided care as usual
Cessation of Benzodiazepine Use	10 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: We excluded nine subjects because they were not eligible.

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.

Outcome measures

Outcome measures
Measure	EMPOWER-ED n=82 Participants Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use EMPOWER-ED: An electronic app that runs on a variety of platforms and provides education and tools designed to promote self-driven reduction of benzodiazepines.	Control n=79 Participants Individuals will be provided care as usual
Anxiety baseline	9.77 units on a scale Standard Deviation 9.17	8.86 units on a scale Standard Deviation 8.81
Anxiety follow-up	8.23 units on a scale Standard Deviation 6.60	7.26 units on a scale Standard Deviation 6.33

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: We excluded nine patients because they were not eligible.

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.

Outcome measures

Outcome measures
Measure	EMPOWER-ED n=82 Participants Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use EMPOWER-ED: An electronic app that runs on a variety of platforms and provides education and tools designed to promote self-driven reduction of benzodiazepines.	Control n=79 Participants Individuals will be provided care as usual
Sleep Quality baseline	23.84 units on a scale Standard Deviation 12.02	24.53 units on a scale Standard Deviation 13.87
Sleep Quality 6-month follow-up	23.80 units on a scale Standard Deviation 8.54	23.64 units on a scale Standard Deviation 7.86

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: We excluded nine patients because they were not eligible.

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.

Outcome measures

Outcome measures
Measure	EMPOWER-ED n=82 Participants Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use EMPOWER-ED: An electronic app that runs on a variety of platforms and provides education and tools designed to promote self-driven reduction of benzodiazepines.	Control n=79 Participants Individuals will be provided care as usual
Overall Health and Quality of Life Baseline Physical Component Summary	38.06 units on a scale Standard Deviation 15.84	38.03 units on a scale Standard Deviation 19.07
Overall Health and Quality of Life Baseline Mental Component Summary	40.19 units on a scale Standard Deviation 18.99	40.21 units on a scale Standard Deviation 17.25
Overall Health and Quality of Life Follow-up Mental Component Summary	40.65 units on a scale Standard Deviation 11.64	41.27 units on a scale Standard Deviation 10.24
Overall Health and Quality of Life Follow-up Physical Component Summary	37.45 units on a scale Standard Deviation 10.77	37.26 units on a scale Standard Deviation 13.03

Adverse Events

EMPOWER-ED

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Keith Humphreys, PhD

VA Palo Alto Health Care System

Phone: (650) 493-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place