Clinical trial NCT06359314: Anxiety Lowering and Deprescribing Through Emotion Regulation
Official title: Positive Emotion Regulation Intervention for Benzodiazepine Receptor Agonist Deprescribing in Older Adults: Anxiety Lowering and Deprescribing Through Emotion Regulation (ALDER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benzodiazepine Dependence
Anxiety Disorders
Sleep Disturbance
Keywords: Benzodiazepine receptor agonists
Positive emotion
Sleep disturbance
Anxiety
Coping
Stress
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of intervention
timeFrame: Measured post-intervention (7-weeks).
measure: Acceptability of intervention
timeFrame: Measured post-intervention (7-weeks).
measure: Adoption of intervention
timeFrame: Measured post-intervention (7-weeks).
Secondary outcomes:
measure: Patient benzodiazepine receptor agonist (BZRA) use
timeFrame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
measure: Patient attitude towards deprescribing BZRAs
timeFrame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
measure: Patient-reported sleep disturbance
timeFrame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
measure: Patient-reported anxiety
timeFrame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
measure: Patient-reported stress
timeFrame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
measure: Patient-reported depression
timeFrame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
measure: Patient-reported positive affect
timeFrame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
measure: Patient-reported meaning and purpose
timeFrame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
measure: Patient-reported comorbidities
timeFrame: Measured at baseline (pre-intervention).
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Elizabeth Addington, PhD
role: PRINCIPAL_INVESTIGATOR
References: