Anxiety Lowering and Deprescribing Through Emotion Regulation (ALDER)

Positive Emotion Regulation Intervention for Benzodiazepine Receptor Agonist Deprescribing in Older Adults: Anxiety Lowering and Deprescribing Through Emotion Regulation (ALDER)

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Sleep Disturbance; Benzodiazepine Dependence
• Intervention / Treatment: Behavioral: ALDER

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Behavioral: ALDER; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Benzodiazepine Receptor Agonist (BZRA) Use	Three questions asking patients which medication they use, their frequency of use (times per week), and their reason for use (anxiety, stress, sleep, other).	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Patient-reported Sleep Disturbance	Measured using Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Sleep Disturbance computer adaptive test, which assesses self-reported perceptions of sleep quality, depth, and restoration within the past 7 days, including difficulty falling asleep and staying asleep and sleep satisfaction. Higher scores indicate higher levels of sleep disturbance. 50 indicates the population mean with a standard deviation of 10.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Patient-reported Anxiety	Measured using Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Anxiety computer adaptive test, which assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Higher scores indicate higher levels of anxiety. 50 indicates the population mean with a standard deviation of 10.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Patient-reported Stress	Measured using using the Perceived Stress Scale (PSS-4), which assesses how overloaded, unpredictable, and uncontrollable respondents perceive their lives to be. The minimum score is 0 and the maximum score is 16, with higher scores indicating a higher stress level.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Patient-reported Depression	Measured using Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Depression computer adaptive test which assesses self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Higher scores indicate higher levels of depression. 50 indicates the population mean with a standard deviation of 10.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Patient-reported Positive Affect	Measured using Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0- Positive Affect computer adaptive test, which assesses momentary positive or rewarding affective experiences, such as feelings and mood associated with pleasure, joy, elation, contentment, pride, affection, happiness, engagement, and excitement. Higher scores indicate higher levels of positive affect. 50 indicates the population mean with a standard deviation of 10.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Patient-reported Meaning and Purpose	Measured using Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0- Meaning and Purpose computer adaptive test, which assesses one's sense of life having purpose and that there are good reasons for living. Higher scores indicate hopefulness, optimism, goal-directedness, and feelings that one's life is worthy. 50 indicates the population mean with a standard deviation of 10.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Elizabeth Addington, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Actual): September 5, 2024
• Study Completion (Actual): September 10, 2024

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Anxiety; Stress; Coping; Sleep disturbance; Positive emotion; Benzodiazepine receptor agonists
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Anxiety Disorders; Parasomnias
• Other Study ID Numbers: STU00219362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No