Anxiety Lowering and Deprescribing Through Emotion Regulation

Positive Emotion Regulation Intervention for Benzodiazepine Receptor Agonist Deprescribing in Older Adults: Anxiety Lowering and Deprescribing Through Emotion Regulation (ALDER)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06359314

Acronym

ALDER

Enrollment

Registered

2024-04-11

Start date

2024-05-16

Completion date

2024-09-10

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Benzodiazepine Dependence, Sleep Disturbance

Keywords

Benzodiazepine receptor agonists, Positive emotion, Sleep disturbance, Anxiety, Coping, Stress

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.

Interventions

BEHAVIORALALDER

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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* Dementia, seizure, or REM sleep disorder diagnosis. * In hospice care. * No daily internet access. * Cannot speak and read English.

Design outcomes

Primary

Measure	Time frame	Description
Adoption of Intervention	Measured post-intervention (7-weeks).	Measured via usage metrics from the BrightOutcome intervention platform (e.g., mean number of skills accessed).
Feasibility of Intervention	Measured post-intervention (7-weeks).	Measured by enrollment rate (# consented/# eligible) and retention rate (# of complete post-intervention assessments/# consented).
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. 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.

Secondary

Measure	Time frame	Description
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-reported Depression	Measured at baseline (pre-intervention) and post-intervention (7-weeks).	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.
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 Meaning and Purpose	Measured at baseline (pre-intervention) and post-intervention (7-weeks).	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.
Patient-reported Positive Affect	Measured at baseline (pre-intervention) and post-intervention (7-weeks).	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.
Patient-reported Sleep Disturbance	Measured at baseline (pre-intervention) and post-intervention (7-weeks).	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.
Patient-reported Anxiety	Measured at baseline (pre-intervention) and post-intervention (7-weeks).	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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited from Northwestern Medicine using electronic messages.

Pre-assignment details

Participants who met all eligibility requirements and provided informed consent were given access to the web-based intervention.

Participants by arm

Arm	Count
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.	33
Total	33

Arm

Count

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.

Total

Baseline characteristics

Characteristic	Intervention
Age, Continuous	73 years STANDARD_DEVIATION 6
Comorbidities	2.35 number of comorbid chronic health condit STANDARD_DEVIATION 1.6
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	6 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	25 Participants
Reasons for BZRA use Anxiety or stress only	9 Participants
Reasons for BZRA use Both anxiety/stress and sleep	7 Participants
Reasons for BZRA use Sleep only	17 Participants
Sex: Female, Male Female	20 Participants
Sex: Female, Male Male	13 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 33
other Total, other adverse events	0 / 33
serious Total, serious adverse events	0 / 33

Outcome results

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.

Time frame: Measured post-intervention (7-weeks).

Population: n=16 provided data at post-intervention

Arm	Measure	Value (MEAN)	Dispersion
Intervention	Acceptability of Intervention	3.72 Scores on a Scale	Standard Deviation 1.1

Primary

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).

Arm	Measure	Value (MEAN)	Dispersion
Intervention	Adoption of Intervention	4 number of skills used (min 0, max 8)	Standard Deviation 3.5

Primary

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).

Population: n=49 were eligible; n=33 consented; n=16 were retained at post-intervention

Arm	Measure	Group	Value (NUMBER)
Intervention	Feasibility of Intervention	Enrollment rate	67 Percentage of participants
Intervention	Feasibility of Intervention	Retention rate	48 Percentage of participants

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).