Trial Outcomes & Findings for Anxiety Lowering and Deprescribing Through Emotion Regulation (NCT NCT06359314)

NCT ID: NCT06359314

Last Updated: 2025-12-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: Measured post-intervention (7-weeks).
• Results posted on: 2025-12-16

Participant Flow

Participants were recruited from Northwestern Medicine using electronic messages.

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

Participant milestones

Measure	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.
Overall Study STARTED	33
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anxiety Lowering and Deprescribing Through Emotion Regulation

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: Measured post-intervention (7-weeks).

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

Measured by enrollment rate (# consented/# eligible) and retention rate (# of complete post-intervention assessments/# consented).

Outcome measures

Measure	Intervention n=49 Participants 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.
Feasibility of Intervention Retention rate	48 Percentage of participants
Feasibility of Intervention Enrollment rate	67 Percentage of participants

PRIMARY outcome

Timeframe: Measured post-intervention (7-weeks).

Population: n=16 provided data at post-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.

Outcome measures

Measure

Intervention n=16 Participants 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.

Acceptability of Intervention

3.72 Scores on a Scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: Measured post-intervention (7-weeks).

Measured via usage metrics from the BrightOutcome intervention platform (e.g., mean number of skills accessed).

Outcome measures

Measure

Intervention n=33 Participants 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.

Adoption of Intervention

4 number of skills used (min 0, max 8) Standard Deviation 3.5

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Intervention n=33 Participants 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.
Patient Benzodiazepine Receptor Agonist (BZRA) Use Baseline BZRA usage	6 days per week Interval 1.0 to 7.0
Patient Benzodiazepine Receptor Agonist (BZRA) Use Post-intervention BZRA usage	5 days per week Interval 2.0 to 7.0

SECONDARY outcome

Timeframe: Measured at baseline (pre-intervention) and post-intervention (7-weeks).

Population: n=16 were retained at post-intervention

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.

Outcome measures

Measure	Intervention n=33 Participants 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.
Patient-reported Sleep Disturbance Baseline sleep disturbance	54.39 T-score Standard Deviation 8.01
Patient-reported Sleep Disturbance Post-intervention sleep disturbance	52.79 T-score Standard Deviation 10.11

SECONDARY outcome

Timeframe: Measured at baseline (pre-intervention) and post-intervention (7-weeks).

Population: n=16 were retained at post-intervention

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.

Outcome measures

Measure	Intervention n=33 Participants 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.
Patient-reported Anxiety Baseline anxiety	58.47 T-score Standard Deviation 5.39
Patient-reported Anxiety Post-intervention anxiety	57.49 T-score Standard Deviation 6.65

SECONDARY outcome

Timeframe: Measured at baseline (pre-intervention) and post-intervention (7-weeks).

Population: n=16 were retained at post-intervention

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.

Outcome measures

Measure	Intervention n=33 Participants 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.
Patient-reported Stress Baseline stress	5.55 Scores on a Scale Standard Deviation 2.95
Patient-reported Stress Post-intervention stress	4.94 Scores on a Scale Standard Deviation 4.11

SECONDARY outcome

Timeframe: Measured at baseline (pre-intervention) and post-intervention (7-weeks).

Population: n=16 were retained at post-intervention

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.

Outcome measures

Measure	Intervention n=33 Participants 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.
Patient-reported Depression Baseline depression	53.58 T-score Standard Deviation 5.72
Patient-reported Depression Post-intervention depression	52.52 T-score Standard Deviation 8.00

SECONDARY outcome

Timeframe: Measured at baseline (pre-intervention) and post-intervention (7-weeks).

Population: n=16 were retained at post-intervention

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.

Outcome measures

Measure	Intervention n=33 Participants 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.
Patient-reported Positive Affect Baseline positive affect	41.42 T-score Standard Deviation 6.65
Patient-reported Positive Affect Post-intervention positive affect	42.31 T-score Standard Deviation 9.08

SECONDARY outcome

Timeframe: Measured at baseline (pre-intervention) and post-intervention (7-weeks).

Population: n=1 did not complete this measure at baseline; n=16 were retained at post-intervention

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.

Outcome measures

Measure	Intervention n=32 Participants 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.
Patient-reported Meaning and Purpose Baseline meaning and purpose	45.51 T-score Standard Deviation 9.5
Patient-reported Meaning and Purpose Post-intervention meaning and purpose	48.23 T-score Standard Deviation 11.74

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth L. Addington, PhD

Northwestern University Feinberg School of Medicine

Phone: 3125033808

Email: elizabeth.addington@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place