Anxiety Lowering and Deprescribing Through Emotion Regulation
- Conditions
- Anxiety DisordersSleep DisturbanceBenzodiazepine Dependence
- Interventions
- Behavioral: ALDER
- Registration Number
- NCT06359314
- Lead Sponsor
- Northwestern University
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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.
- Dementia, seizure, or REM sleep disorder diagnosis.
- In hospice care.
- No daily internet access.
- Cannot speak and read English.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention ALDER Participants will go through a 5-week online self-guided positive emotion skills course.
- Primary Outcome Measures
Name Time Method Feasibility of intervention Measured post-intervention (7-weeks). Measured by enrollment rate (# consented/# eligible) and retention rate (# of complete post-intervention assessments/# consented).
Adoption of intervention Measured post-intervention (7-weeks). Measured via usage metrics from the BrightOutcome intervention platform (e.g., mean % of pages viewed, number of skills and practice exercises used).
Acceptability of intervention 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.
- Secondary Outcome Measures
Name Time Method Patient benzodiazepine receptor agonist (BZRA) use Measured at baseline (pre-intervention) and post-intervention (7-weeks). Three questions asking patients which medication they use, their frequency of use (times per week), and their reason for use (anxiety, stress, sleep, other).
Patient-reported stress Measured at baseline (pre-intervention) and post-intervention (7-weeks). 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.
Patient attitude towards deprescribing BZRAs Measured at baseline (pre-intervention) and post-intervention (7-weeks). Measured using the revised Patients' Attitudes towards Deprescribing (rPATD) questionnaire for BZRAs, which assesses concerns about stopping their BZRA, inappropriateness of their BZRA use, and dependence on their BZRA. The minimum score is 13 and the maximum score is 65, with a higher score indicating higher resistance to deprescribing.
Patient-reported anxiety Measured at baseline (pre-intervention) and post-intervention (7-weeks). Measured using 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.
Patient-reported depression Measured at baseline (pre-intervention) and post-intervention (7-weeks). Measured using 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.
Patient-reported positive affect Measured at baseline (pre-intervention) and post-intervention (7-weeks). Measured using 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.
Patient-reported sleep disturbance Measured at baseline (pre-intervention) and post-intervention (7-weeks). Measured using 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.
Patient-reported meaning and purpose Measured at baseline (pre-intervention) and post-intervention (7-weeks). Measured using 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.
Patient-reported comorbidities Measured at baseline (pre-intervention). Measured using the Self-Administered Comorbidity Questionnaire, which assesses the types of conditions the participant has.
Trial Locations
- Locations (1)
Northwestern Medicine
🇺🇸Chicago, Illinois, United States