Anxiety Lowering and Deprescribing Through Emotion Regulation

Anxiety Disorders Clinical Trial

— ALDER  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06359314
• Other study ID #: STU00219362
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: Caroline Leong
• Phone: 312-503-5247
• Email: caroline.leong1[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Benzodiazepine Dependence
• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of intervention	Measured by enrollment rate (# consented/# eligible) and retention rate (# of complete post-intervention assessments/# consented).	Measured post-intervention (7-weeks).
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.	Measured post-intervention (7-weeks).
Primary	Adoption of intervention	Measured via usage metrics from the BrightOutcome intervention platform (e.g., mean % of pages viewed, number of skills and practice exercises used).	Measured post-intervention (7-weeks).
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).	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Secondary	Patient attitude towards deprescribing BZRAs	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.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Secondary	Patient-reported sleep disturbance	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.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Secondary	Patient-reported anxiety	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.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
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.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Secondary	Patient-reported depression	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.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Secondary	Patient-reported positive affect	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.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Secondary	Patient-reported meaning and purpose	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.	Measured at baseline (pre-intervention) and post-intervention (7-weeks).
Secondary	Patient-reported comorbidities	Measured using the Self-Administered Comorbidity Questionnaire, which assesses the types of conditions the participant has.	Measured at baseline (pre-intervention).