An interventional study of ALDER in Benzodiazepine Dependence, Anxiety Disorders and Sleep Disturbance, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Northwestern University · Not applicable, Interventional, and Supportive care
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:
Participants will complete the 5-week online self-guided ALDER intervention as well as two survey assessments, one before the intervention and one after.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 33 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Feasibility of Intervention
Measured by enrollment rate (# consented/# eligible) and retention rate (# of complete post-intervention assessments/# consented).
Time frame: 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.
Time frame: Measured post-intervention (7-weeks).
Adoption of Intervention
Measured via usage metrics from the BrightOutcome intervention platform (e.g., mean number of skills accessed).
Time frame: Measured post-intervention (7-weeks).
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Participants were recruited from Northwestern Medicine using electronic messages.
| Milestone | Intervention |
|---|---|
| Started | 33 |
| Completed | 16 |
| Not completed | 17 |
Measured by enrollment rate (# consented/# eligible) and retention rate (# of complete post-intervention assessments/# consented).
| Percentage of participants | Intervention |
|---|---|
| Enrollment rate | 67 |
| Retention rate | 48 |
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.
| Scores on a Scale | Intervention |
|---|---|
| Acceptability of Intervention | 3.72 ± 1.1 |
Measured via usage metrics from the BrightOutcome intervention platform (e.g., mean number of skills accessed).
| number of skills used (min 0, max 8) | Intervention |
|---|---|
| Adoption of Intervention | 4 ± 3.5 |
Three questions asking patients which medication they use, their frequency of use (times per week), and their reason for use (anxiety, stress, sleep, other).
| days per week | Intervention |
|---|---|
| Baseline BZRA usage | 6 (1 to 7) |
| Post-intervention BZRA usage | 5 (2 to 7) |
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.
| T-score | Intervention |
|---|---|
| Baseline sleep disturbance | 54.39 ± 8.01 |
| Post-intervention sleep disturbance | 52.79 ± 10.11 |
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.
| T-score | Intervention |
|---|---|
| Baseline anxiety | 58.47 ± 5.39 |
| Post-intervention anxiety | 57.49 ± 6.65 |
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.
| Scores on a Scale | Intervention |
|---|---|
| Baseline stress | 5.55 ± 2.95 |
| Post-intervention stress | 4.94 ± 4.11 |
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.
| T-score | Intervention |
|---|---|
| Baseline depression | 53.58 ± 5.72 |
| Post-intervention depression | 52.52 ± 8.00 |
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.
| T-score | Intervention |
|---|---|
| Baseline positive affect | 41.42 ± 6.65 |
| Post-intervention positive affect | 42.31 ± 9.08 |
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.
| T-score | Intervention |
|---|---|
| Baseline meaning and purpose | 45.51 ± 9.5 |
| Post-intervention meaning and purpose | 48.23 ± 11.74 |
Collected over from enrollment until post-intervention, 7 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Continuous(years) | Intervention |
|---|---|
| Mean | 73 ± 6 |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 20 |
| Male | 13 |
| Race (NIH/OMB)(Participants) | Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 25 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Intervention |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 33 |
| Unknown or Not Reported | 0 |
| Comorbidities(number of comorbid chronic health condit) | Intervention |
|---|---|
| Mean | 2.35 ± 1.6 |
| Reasons for BZRA use(Participants) | Intervention |
|---|---|
| Anxiety or stress only | 9 |
| Sleep only | 17 |
| Both anxiety/stress and sleep | 7 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Northwestern University