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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants will go through a 5-week online self-guided positive emotion skills course. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Addington, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medicine | Chicago | Illinois | 60611 | United States |
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Participants who met all eligibility requirements and provided informed consent were given access to the web-based intervention.
Participants were recruited from Northwestern Medicine using electronic messages.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Intervention | Measured by enrollment rate (# consented/# eligible) and retention rate (# of complete post-intervention assessments/# consented). | n=49 were eligible; n=33 consented; n=16 were retained at post-intervention | Posted | Number | Percentage of participants | Measured post-intervention (7-weeks). |
|
from enrollment until post-intervention, 7 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth L. Addington, PhD | Northwestern University Feinberg School of Medicine | 3125033808 | elizabeth.addington@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2024 | Sep 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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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). |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Comorbidities | Self-reported health conditions | Mean | Standard Deviation | number of comorbid chronic health condit |
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| Reasons for BZRA use | Self-reported reason(s) for using benzodiazepine receptor agonist (BZRA) medication(s) | Count of Participants | Participants |
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| Primary | 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. | n=16 provided data at post-intervention | Posted | Mean | Standard Deviation | Scores on a Scale | Measured post-intervention (7-weeks). |
|
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| Primary | Adoption of Intervention | Measured via usage metrics from the BrightOutcome intervention platform (e.g., mean number of skills accessed). | Posted | Mean | Standard Deviation | number of skills used (min 0, max 8) | Measured post-intervention (7-weeks). |
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| Secondary | 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). | Posted | Median | Full Range | days per week | Measured at baseline (pre-intervention) and post-intervention (7-weeks). |
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| Secondary | 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. | n=16 were retained at post-intervention | Posted | Mean | Standard Deviation | T-score | Measured at baseline (pre-intervention) and post-intervention (7-weeks). |
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| Secondary | 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. | n=16 were retained at post-intervention | Posted | Mean | Standard Deviation | T-score | Measured at baseline (pre-intervention) and post-intervention (7-weeks). |
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| Secondary | 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. | n=16 were retained at post-intervention | Posted | Mean | Standard Deviation | Scores on a Scale | Measured at baseline (pre-intervention) and post-intervention (7-weeks). |
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| Secondary | 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. | n=16 were retained at post-intervention | Posted | Mean | Standard Deviation | T-score | Measured at baseline (pre-intervention) and post-intervention (7-weeks). |
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| Secondary | 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. | n=16 were retained at post-intervention | Posted | Mean | Standard Deviation | T-score | Measured at baseline (pre-intervention) and post-intervention (7-weeks). |
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| Secondary | 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. | n=1 did not complete this measure at baseline; n=16 were retained at post-intervention | Posted | Mean | Standard Deviation | T-score | Measured at baseline (pre-intervention) and post-intervention (7-weeks). |
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| 33 |
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| 33 |
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