Trial Outcomes & Findings for Strategies for Treating Anxiety Research Study (NCT NCT05398016)

Last Updated: 2025-06-13

Results Overview

(Patient outcome) Change in anxiety between baseline (pre-treatment) and follow-up (12 weeks; 6 week after intervention end) will be assessed using the Structured Interview Guide for the Hamilton Anxiety Scale. This is a clinician-rated measure consisting of 14 items, each defined by a series of symptoms, to measure both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Total summary score ranges from 0 to 56, with higher scores indicating more severe and frequent symptoms of anxiety. A corresponding interview guide will be used to increase the reliability of the Hamilton Anxiety Scale. This measure has demonstrated sensitivity to change in clinical trials.

Recruitment status

COMPLETED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

change in anxiety between pre-treatment and follow-up (12 weeks)

Results posted on

2025-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	Patient Participants Low-intensity behavioral intervention: Brief behavioral intervention for mild-to-moderate symptoms of anxiety. Delivered via weekly sessions by a trained lay counselor ("coach").	Coach Participants Adults with advanced undergraduate standing or baccalaureate who complete required training and consent to serve as supervised coaches (nonspecialist providers), delivering the brief intervention to patient participants.
Overall Study STARTED	21	6
Overall Study COMPLETED	17	6
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age was collected and analyzed for patient participants only to characterize the sample. Age was not collected as a continuous variable for coach participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Participants n=21 Participants Adults (18+) with clinically elevated symptoms of anxiety who received brief behavioral intervention for mild-to-moderate symptoms of anxiety. Delivered via weekly sessions by a trained lay counselor ("coach").	Coach Participants n=6 Participants Nonspecialists who were trained and supervised to deliver the experimental intervention with the patient participants. Referred to as "coaches."	Total n=27 Participants Total of all reporting groups
Age, Continuous	28.9 years n=21 Participants • Age was collected and analyzed for patient participants only to characterize the sample. Age was not collected as a continuous variable for coach participants.	—	28.9 years n=21 Participants • Age was collected and analyzed for patient participants only to characterize the sample. Age was not collected as a continuous variable for coach participants.
Age, Customized 18 years of age or older	21 Participants n=21 Participants	6 Participants n=6 Participants	27 Participants n=27 Participants
Sex: Female, Male Female	18 Participants n=21 Participants • Data were collected as gender with multiple options.	5 Participants n=6 Participants • Data were collected as gender with multiple options.	23 Participants n=27 Participants • Data were collected as gender with multiple options.
Sex: Female, Male Male	3 Participants n=21 Participants • Data were collected as gender with multiple options.	1 Participants n=6 Participants • Data were collected as gender with multiple options.	4 Participants n=27 Participants • Data were collected as gender with multiple options.
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=21 Participants	1 Participants n=6 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=21 Participants	5 Participants n=6 Participants	24 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants	0 Participants n=6 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=21 Participants	0 Participants n=6 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	8 Participants n=21 Participants	1 Participants n=6 Participants	9 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=21 Participants	0 Participants n=6 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=21 Participants	0 Participants n=6 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	9 Participants n=21 Participants	3 Participants n=6 Participants	12 Participants n=27 Participants
Race (NIH/OMB) More than one race	2 Participants n=21 Participants	1 Participants n=6 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=21 Participants	1 Participants n=6 Participants	3 Participants n=27 Participants
Region of Enrollment United States	21 Participants n=21 Participants	6 Participants n=6 Participants	27 Participants n=27 Participants
Generalized Anxiety Disorder (GAD-7) scale	11.9 units on a scale STANDARD_DEVIATION 2.8 • n=21 Participants • participant-reported anxiety symptom severity; only collected on patient participants	—	11.9 units on a scale STANDARD_DEVIATION 2.8 • n=21 Participants • participant-reported anxiety symptom severity; only collected on patient participants

PRIMARY outcome

Timeframe: through treatment completion, up to 12 weeks

Retention of patient participants will be measured as an implementation outcome. This will entail quantifying the number of patients who complete the entire course of treatment out of all of those enrolled.

Outcome measures

Outcome measures
Measure	Coach Participants n=21 Participants Nonspecialists who were trained and supervised to deliver the experimental behavioral intervention to patient participants.
Number of Patient Participants Retained in the Intervention (Out of All of Those Enrolled), as Measured by Completion to All Study Treatment Visits.	17 Participants

PRIMARY outcome

Timeframe: change in anxiety between pre- and post-treatment (6-8 weeks)

Population: per protocol analysis of completers (n = 17)

(Patient outcome) Change between pre- and post-treatment will be assessed using the Structured Interview Guide for the Hamilton Anxiety Scale. This is a clinician-rated measure consisting of 14 items, each defined by a series of symptoms, to measure both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Total summary score ranges from 0 to 56, with higher scores indicating more severe and frequent symptoms of anxiety. A corresponding interview guide will be used to increase the reliability of the Hamilton Anxiety Scale. This measure has demonstrated sensitivity to change in clinical trials.

Outcome measures

Outcome measures
Measure	Coach Participants n=17 Participants Nonspecialists who were trained and supervised to deliver the experimental behavioral intervention to patient participants.
Change in Anxiety Symptoms	4.69 scores on scale Standard Deviation 4.44

PRIMARY outcome

Timeframe: change in avoidance between pre- and post-treatment (6-8 weeks)

Population: per protocol analysis

(Patient outcome) Change in avoidance will be measured using the Multidimensional Experiential Avoidance Questionnaire (MEAQ). This is a 62-item self report assessment of avoidance. Total scores range from 62 to 372; higher scores reflect higher levels of avoidance. This will be used to measure activation of target mechanism of avoidance.

Outcome measures

Outcome measures
Measure	Coach Participants n=17 Participants Nonspecialists who were trained and supervised to deliver the experimental behavioral intervention to patient participants.
Change in Avoidance	6.68 scores on scale Standard Deviation 23.64

PRIMARY outcome

Timeframe: change in anxiety between pre-treatment and follow-up (12 weeks)

Outcome measures

Outcome measures
Measure	Coach Participants n=17 Participants Nonspecialists who were trained and supervised to deliver the experimental behavioral intervention to patient participants.
Sustained Change in Anxiety Symptoms	4.75 scores on scale Standard Deviation 4.40

SECONDARY outcome

Timeframe: Post-implementation (up to 1 year)

Self-report measure assessing perceived acceptability of the intervention (an implementation outcome). Scores range from 4-20; higher scores indicate a higher degree of perceived acceptability. Completed by the trained lay counselors.

Outcome measures

Outcome measures
Measure	Coach Participants n=6 Participants Nonspecialists who were trained and supervised to deliver the experimental behavioral intervention to patient participants.
Acceptability of Intervention Measure (AIM)	4.88 scores on scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: Post-implementation (up to 1 year)

Self-report measure assessing perceived feasibility of the intervention (an implementation outcome). Scores range from 4-20; higher scores indicate a higher degree of perceived feasibility. Completed by the trained lay counselors.

Outcome measures

Outcome measures
Measure	Coach Participants n=6 Participants Nonspecialists who were trained and supervised to deliver the experimental behavioral intervention to patient participants.
Feasibility of Intervention Measure (FIM)	5 scores on scale Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: Post-implementation (up to 1 year)

Self-report measure assessing perceived appropriateness of the intervention (an implementation outcome). Scores range from 4-20; higher scores indicate a higher degree of perceived appropriateness. Completed by the trained lay counselors.

Outcome measures

Outcome measures
Measure	Coach Participants n=6 Participants Nonspecialists who were trained and supervised to deliver the experimental behavioral intervention to patient participants.
Implementation Appropriateness Measure (IAM)	4.88 scores on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: change in functioning between pre- and post-treatment (6-8 weeks)

Population: per protocol analysis

This 12-item generic health-status measure assesses functioning across six domains: communication, mobility, self-care, interpersonal, life activities, and participation. Each item is scored on a 5-point scale (0 = no difficulty to 4 = extreme difficulty or cannot do). The scores for each item are summed to create a total score. A total score is possible from 0-48, with 48 representing the highest level of disability.

Outcome measures

Outcome measures
Measure	Coach Participants n=17 Participants Nonspecialists who were trained and supervised to deliver the experimental behavioral intervention to patient participants.
World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)	4.600 score on a scale Standard Deviation 10.99

OTHER_PRE_SPECIFIED outcome

Timeframe: change in avoidance between pre-treatment and follow-up (12 weeks)

Population: per protocol analysis

(Patient outcome) Sustained change in avoidance after treatment (12 weeks follow-up; this is 6 weeks after treatment end) will be measured using the Multidimensional Experiential Avoidance Questionnaire (MEAQ). This is a 62-item self report assessment of avoidance. Total scores range from 62 to 372; higher scores reflect higher levels of avoidance. This will be used to measure activation of target mechanism of avoidance.

Outcome measures

Outcome measures
Measure	Coach Participants n=17 Participants Nonspecialists who were trained and supervised to deliver the experimental behavioral intervention to patient participants.
Sustained Change in Avoidance	11.71 scores on scale Standard Deviation 10.93

Adverse Events

Patient Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Coach Participants

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

Dr. Brenna Renn, PI

University of Nevada Las Vegas

Phone: 7028950569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place