Anxiety Lowering and Deprescribing Through Emotion Regulation

NCT06359314 | Completed Results

• 1 other identifier: STU00219362
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance; Anxiety Disorders; Benzodiazepine Dependence

Keywords

Benzodiazepine receptor agonists; Positive emotion; Sleep disturbance; Anxiety; Coping; Stress

Outcome Measures

Primary Outcomes (3)

• Feasibility of Intervention

  Measured by enrollment rate (# consented/# eligible) and retention rate (# of complete post-intervention assessments/# consented).

  Measured post-intervention (7-weeks).

• Acceptability of Intervention

  Measured during the post-intervention assessment using the Acceptability of Intervention Measure to evaluate relevance of and satisfaction with the ALDER intervention. Examples of survey items include "ALDER meets my approval" and "I like ALDER." The final score is an average of the scores from 4 items. Maximum score is 5, minimum score is 1. Higher scores indicate greater acceptability.

  Measured post-intervention (7-weeks).

• Adoption of Intervention

  Measured via usage metrics from the BrightOutcome intervention platform (e.g., mean number of skills accessed).

  Measured post-intervention (7-weeks).

Secondary Outcomes (7)

• Patient Benzodiazepine Receptor Agonist (BZRA) Use

  Measured at baseline (pre-intervention) and post-intervention (7-weeks).

• Patient-reported Sleep Disturbance

  Measured at baseline (pre-intervention) and post-intervention (7-weeks).

• Patient-reported Anxiety

  Measured at baseline (pre-intervention) and post-intervention (7-weeks).

• Patient-reported Stress

  Measured at baseline (pre-intervention) and post-intervention (7-weeks).

• Patient-reported Depression

  Measured at baseline (pre-intervention) and post-intervention (7-weeks).

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: ALDER

Interventions

ALDER BEHAVIORAL

The ALDER skills are delivered over approximately 5 weeks. A week consists of learning at least one skill and then applying that skill(s) in daily home practice throughout the week. Skill lessons and daily home practice exercises are housed on the ALDER website. Participants have the option to share their home practice responses with fellow participants by posting them to the discussion board, where they can like and comment on each other's posts.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

Given the small sample size, this study is not powered to detect statistically significant changes. This is a single-arm trial; therefore, any changes from baseline to post-intervention cannot necessarily be attributed to the intervention.

Results Point of Contact

• Title: Elizabeth L. Addington, PhD
• Organization: Northwestern University Feinberg School of Medicine

elizabeth.addington@northwestern.edu

3125033808

Study Officials

• Elizabeth Addington, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 11, 2024
• Study Start: May 16, 2024
• Primary Completion: September 5, 2024
• Study Completion: September 10, 2024
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)