Anxiety Lowering and Deprescribing Through Emotion Regulation
NCT ID: NCT06359314
Last Updated: 2025-12-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
33 participants
INTERVENTIONAL
2024-05-16
2024-09-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
Participants will go through a 5-week online self-guided positive emotion skills course.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ≥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
* In hospice care.
* No daily internet access.
* Cannot speak and read English.
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Northwestern University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elizabeth Addington
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elizabeth Addington, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northwestern Medicine
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STU00219362
Identifier Type: -
Identifier Source: org_study_id