Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04572750
Acronym
EMPOWER-ED
Enrollment
170
Registered
2020-10-01
Start date
2022-06-01
Completion date
2024-07-03
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benzodiazepine Dependence, Taking Benzodiazepines for Any Reason for 3 Months

Keywords

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

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.

Detailed description

Background: Long-term use of benzodiazepine medication has been increasing sharply inside and outside of VA, raising the risk of cognitive decline, falls, and overdose among patients. A self-directed benzodiazepine tapering intervention known as EMPOWER was shown effective in a non-VA clinical trial, and within VA there is significant interest in tailoring it to and providing it for Veterans. Significance: Although often useful as short-term medications, when taken for extended periods benzodiazepines carry risk of cognitive decline and other brain damage, falls and other accidents, benzodiazepine dependence and opioid-benzodiazepine overdose (VA Pharmacy Benefits Management Academic Detailing Service, 2017). This is major concern within VA, which prescribes benzodiazepines to over 350,000 Veterans a year, 2/3 of whom take them long-term (i.e., 3 months or more) (VA Pharmacy Benefits Management Academic Detailing Service, 2017). Innovation: Because the EMPOWER intervention was paper-and-pencil based, it would be useful to convert it to an electronic version that worked on smart phones, tablets, and/or desktop computers. Accordingly, the proposed project intends to convert EMPOWER to electronic format and to tailor it to the needs and preferences of the Veteran population. Specific Aims: Aim 1: Tailor a promising non-VA benzodiazepine cessation intervention (EMPOWER) to Veterans and simultaneously convert it from paper-and-pencil to electronic format. Aim 2: Conduct a randomized clinical trial of the effectiveness of the tailored, electronic intervention (EMPOWER-ED) on VA primary care patients' benzodiazepine cessation/reduction and functional outcomes. Aim 3: Conduct a budget impact analysis to estimate the costs of implementing the EMPOWER-ED throughout VA. Methodology: This conversion and tailoring will be an iterative process that the project team will conduct via focus groups comprising Veterans, VA primary care providers, and VA operational partners. When the revised intervention, called EMPOWER-ED (for EMPOWER "Electronically Delivered"), is fully designed and has been successfully beta-tested by Veterans, its effectiveness will be evaluated in a randomized clinical trial with 170 Veterans who have been on benzodiazepines for at least 3 months. The primary hypothesis of the study is that those receiving EMPOWER-ED will be significantly more likely than controls to cease benzodiazepines entirely, and, to reduce their dose by at least 25%, at 6-month follow-up. The secondary hypothesis is that Veterans receiving EMPOWER-ED will also experience fewer anxiety symptoms, better sleep quality, and overall health/quality of life at 6-month follow-up. A supplemental analysis of benzodiazepine use only will be conducted using VA databases at 12 months to evaluate whether changes identified at 6 months persist over time. The VA operational partners of the project team (Pharmacy Benefits Management, Psychotropic Drug Safety Initiative, and Office of Connected Care) are committed to disseminating EMPOWER-ED if it proves successful. Therefore, a third aim of the study is to undertake a budget impact analysis to determine what the costs would be to implement EMPOWER-ED in the VA systemwide. Next Steps/Implementation: Because electronically-delivered interventions are inexpensive to disseminate once they have been developed, this project has an excellent chance to promote health care value by creating an easily scaled-up, method of reducing the prevalence of a widespread risk to Veterans' health.

Interventions

BEHAVIORALEMPOWER-ED

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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

At follow-up interview, the interviewer will no know whether the individual was in the treatment or control condition.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
25% Reduction in Benzodiazepine Use6 monthsThis outcome reflects an individual cutting their dose of benzodiazepine medication by one quarter or more
Cessation of Benzodiazepine Use6 MonthsThis outcome reflects an individual eliminating their benzodiazepine use from baseline to 6 month follow-up

Secondary

MeasureTime frameDescription
AnxietyBaseline, 6 monthsAnxiety 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.
Sleep QualityBaseline, 6 monthsThis 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.
Overall Health and Quality of LifeBaseline, 6 monthsOverall 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKeith N. Humphreys, PhD MA

VA Palo Alto Health Care System, Palo Alto, CA

PRINCIPAL_INVESTIGATORMichael A Cucciare, PhD

Central Arkansas Veterans Healthcare System , Little Rock, AR

Participant flow

Recruitment details

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

Participants by arm

ArmCount
EMPOWER-ED
Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use
82
Control
Individuals will be provided care as usual
79
Total161

Baseline characteristics

CharacteristicControlTotalEMPOWER-ED
Age, Continuous61.48 years
STANDARD_DEVIATION 13.88
61.89 years
STANDARD_DEVIATION 13.69
62.28 years
STANDARD_DEVIATION 13.58
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
6 Participants11 Participants5 Participants
Race (NIH/OMB)
More than one race
3 Participants4 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
68 Participants143 Participants75 Participants
Sex: Female, Male
Female
16 Participants27 Participants11 Participants
Sex: Female, Male
Male
63 Participants134 Participants71 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 852 / 85
other
Total, other adverse events
0 / 850 / 85
serious
Total, serious adverse events
0 / 850 / 85

Outcome results

Primary

25% Reduction in Benzodiazepine Use

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

Time frame: 6 months

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
EMPOWER-ED25% Reduction in Benzodiazepine Use14 Participants
Control25% Reduction in Benzodiazepine Use6 Participants
Primary

Cessation of Benzodiazepine Use

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

Time frame: 6 Months

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
EMPOWER-EDCessation of Benzodiazepine Use10 Participants
ControlCessation of Benzodiazepine Use2 Participants
Secondary

Anxiety

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.

Time frame: Baseline, 6 months

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

ArmMeasureGroupValue (MEAN)Dispersion
EMPOWER-EDAnxietybaseline9.77 units on a scaleStandard Deviation 9.17
EMPOWER-EDAnxietyfollow-up8.23 units on a scaleStandard Deviation 6.6
ControlAnxietybaseline8.86 units on a scaleStandard Deviation 8.81
ControlAnxietyfollow-up7.26 units on a scaleStandard Deviation 6.33
Secondary

Overall Health and Quality of Life

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.

Time frame: Baseline, 6 months

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

ArmMeasureGroupValue (MEAN)Dispersion
EMPOWER-EDOverall Health and Quality of LifeBaseline Physical Component Summary38.06 units on a scaleStandard Deviation 15.84
EMPOWER-EDOverall Health and Quality of LifeFollow-up Physical Component Summary37.45 units on a scaleStandard Deviation 10.77
EMPOWER-EDOverall Health and Quality of LifeBaseline Mental Component Summary40.19 units on a scaleStandard Deviation 18.99
EMPOWER-EDOverall Health and Quality of LifeFollow-up Mental Component Summary40.65 units on a scaleStandard Deviation 11.64
ControlOverall Health and Quality of LifeFollow-up Mental Component Summary41.27 units on a scaleStandard Deviation 10.24
ControlOverall Health and Quality of LifeBaseline Physical Component Summary38.03 units on a scaleStandard Deviation 19.07
ControlOverall Health and Quality of LifeBaseline Mental Component Summary40.21 units on a scaleStandard Deviation 17.25
ControlOverall Health and Quality of LifeFollow-up Physical Component Summary37.26 units on a scaleStandard Deviation 13.03
Secondary

Sleep Quality

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.

Time frame: Baseline, 6 months

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

ArmMeasureGroupValue (MEAN)Dispersion
EMPOWER-EDSleep Qualitybaseline23.84 units on a scaleStandard Deviation 12.02
EMPOWER-EDSleep Quality6-month follow-up23.80 units on a scaleStandard Deviation 8.54
ControlSleep Qualitybaseline24.53 units on a scaleStandard Deviation 13.87
ControlSleep Quality6-month follow-up23.64 units on a scaleStandard Deviation 7.86

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026