Anxiety Lowering and Deprescribing Through Emotion Regulation (ALDER)

Northwestern University

Status: Completed

Conditions: Benzodiazepine Dependence; Sleep Disturbance; Anxiety Disorders

Treatments: Behavioral: ALDER

Study type: Interventional

Funder types: Other

Identifiers

NCT06359314

STU00219362

Details and patient eligibility

About

The goal of this clinical trial is to test ALDER (Anxiety Lowering and Deprescribing through Emotion Regulation), an online self-guided positive emotion intervention, in patients over the age of 65 who are candidates for benzodiazepine receptor agonist (BZRA, commonly called benzos, or z-drugs) deprescribing. The main questions it aims to answer are:

• Is ALDER relevant to and satisfactory for older adult BZRA users?
• Does ALDER help to increase positive emotions and decrease anxiety, trouble sleeping, and use of BZRA medications?

Participants will complete the 5-week online self-guided ALDER intervention as well as two survey assessments, one before the intervention and one after.

Full description

ALDER (Anxiety Lowering and Deprescribing through Emotion Regulation) is a pilot trial of an online positive emotion intervention for adults age 65 and over who are candidates for benzodiazepine receptor agonist (BZRA) deprescribing. The ALDER intervention is 5 weeks long and involves weekly self-guided positive emotion skill lessons and daily skill practice exercises, both housed on the ALDER website.

Up to n=40 patients over the age of 65 will be recruited from Northwestern Medicine Primary Care clinics. To participate, patients must have (1) a BZRA prescription from Northwestern Medicine Primary Care within the past year, (2) at least 1 NM Primary Care visit in the past year, and (3) take a BZRA at least twice a week. Participants will complete survey assessments via REDCap before and after they go through the ALDER intervention. All study activities will take place online.

Feasibility, acceptability, and adoption of the ALDER program will be assessed using enrollment and retention rates, website user data, and measures of relevance and satisfaction in the post-intervention assessment. Patient reported outcomes such as anxiety, sleep and positive affect will be measured both pre- and post-intervention and rate of BZRA usage will be extracted from participant medical records.

Enrollment: 33 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 65 and over.
• ≥1 NM Internal Medicine clinic visit within the past year.
• BZRA prescribed by NM primary care within the past year.
• Takes BZRA at least twice a week.
• Daily access to internet-connected device.
• Ability to read and speak English.

Exclusion criteria

• Dementia, seizure, or REM sleep disorder diagnosis.
• In hospice care.
• No daily internet access.
• Cannot speak and read English.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Intervention

Experimental group

Description:

Participants will go through a 5-week online self-guided positive emotion skills course.

Treatment:

Behavioral: ALDER