Benzodiazepine DependenceALDERNCT06359314
Anxiety Lowering and Deprescribing Through Emotion Regulation
A study testing ALDER in people with Benzodiazepine Dependence and Anxiety Disorders, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Benzodiazepine Dependence, Anxiety Disorders, Sleep Disturbance
- What is being tested?
- ALDER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2024to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- Dementia, seizure, or REM sleep disorder diagnosis.
- In hospice care.
- No daily internet access.
- Cannot speak and read English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- ALDER
- Keywords
- Benzodiazepine receptor agonists, Positive emotion, Sleep disturbance, Anxiety, Coping, Stress
- Medical subject headings
- Anxiety Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALDERBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will go through a 5-week online self-guided positive emotion skills course. Receives: Behavioral: ALDER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention
Measured by enrollment rate (# consented/# eligible) and retention rate (# of complete post-intervention assessments/# consented).
Measured: 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: 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: Measured post-intervention (7-weeks).
Secondary outcomes (7)
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: 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: 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: 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: 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: 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: 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: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start16 May 2024
- Primary completion5 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benzodiazepine DependenceStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Addington, Northwestern University
- Investigators
- Elizabeth Addington, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359314
- Sponsor's protocol ID
- STU00219362
- Acronym
- ALDER
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2024
- Last updated
- 16 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Emotion Regulation Intervention for Benzodiazepine Receptor Agonist Deprescribing in Older Adults: Anxiety Lowering and Deprescribing Through Emotion Regulation (ALDER)
- ClinicalTrials.gov ID
- NCT06359314
- Acronym / sponsor ID
- ALDER / STU00219362
- Keywords
- Benzodiazepine receptor agonists, Positive emotion, Sleep disturbance, Anxiety, Coping, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Posted 16 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ALDERParticipants will go through a 5-week online self-guided positive emotion skills course. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Dementia, seizure, or REM sleep disorder diagnosis.
- In hospice care.
- No daily internet access.
- Cannot speak and read English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALDERThe 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. | Behavioural | Intervention |
Primary outcome
Feasibility of Intervention
Time frame: Measured post-intervention (7-weeks).
Measured by enrollment rate (# consented/# eligible) and retention rate (# of complete post-intervention assessments/# consented).
Acceptability of Intervention
Time frame: Measured post-intervention (7-weeks).
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.
Adoption of Intervention
Time frame: Measured post-intervention (7-weeks).
Measured via usage metrics from the BrightOutcome intervention platform (e.g., mean number of skills accessed).
7 secondary outcomes
Patient Benzodiazepine Receptor Agonist (BZRA) Use
Time frame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Patient-reported Sleep Disturbance
Time frame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Patient-reported Anxiety
Time frame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Patient-reported Stress
Time frame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Patient-reported Depression
Time frame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Patient-reported Positive Affect
Time frame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Patient-reported Meaning and Purpose
Time frame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Addington, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALDER in people with Benzodiazepine Dependence and Anxiety Disorders, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention (time frame: Measured post-intervention (7-weeks).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.