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Strategies for Treating Anxiety Research Study
NA trial testing low-intensity intervention for anxiety in Anxiety Disorders in 27 participants. Completed in 6 December 2024.
| Lead sponsor | University of Nevada, Las Vegas |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 8 January 2024 |
| Primary completion | 18 July 2024 |
| Estimated completion | 6 December 2024 |
| Sites | 1 location across United States |
University of Nevada, Las Vegas
18 and older, any sex, with Anxiety Disorders or Anxiety. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Coach Participants | 4.88 | 4 – 5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Coach Participants | 5 | 5 – 5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Coach Participants | 4.88 | 4 – 5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Patient Participants | 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.
| Group | Value | 95% CI |
|---|---|---|
| Patient Participants | 4.69 | ± 4.44 |
(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.
| Group | Value | 95% CI |
|---|---|---|
| Patient Participants | 6.68 | ± 23.64 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Patient Participants | 4.600 | ± 10.99 |
(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
| Group | Value | 95% CI |
|---|---|---|
| Patient Participants | 4.75 | ± 4.40 |
(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.
| Group | Value | 95% CI |
|---|---|---|
| Patient Participants | 11.71 | ± 10.93 |
This single-arm pilot clinical trial will evaluate the feasibility, acceptability, and engagement of target mechanism, and preliminary impact of a low-intensity behavioral intervention for mild-to-moderate anxiety disorders. Treatment will delivered by trained lay counselors ("coaches;" n = 5-6) to 2-5 patient participants each depending on enrollment and scheduling (n = up to 25).
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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