Table 3:
MHAPPS Trial Exploratory and Safety Outcomes & Baseline Clinical Characteristics
| Patients | Providers/Staff | |||||||
|---|---|---|---|---|---|---|---|---|
| CC | CC+ | Adjusted Mean Difference (95% CI) | p-value | CC | CC+ | Adjusted Mean Difference (95% CI) | p-value | |
| Anxiety (GAD-7) a | ||||||||
| Baseline Anxiety | N=166 | N=165 | N=168 | N=167 | ||||
| Mean (SD) | 9.3 (5.3) | 8.8 (5.3) | 7.8 (4.4) | 8.4 (5) | ||||
| Moderate/high anxiety, No. (%) | 62 (37.3%) | 61 (37.0%) | 44 (26.2%) | 51 (30.5%) | ||||
| Follow-up Anxiety | N=165 | N=159 | N=165 | N=166 | ||||
| Mean (SD) | 7.9 (5.6) | 7.3 (5) | −0.3 (−1.3, 0.7) | 0.54 | 6.8 (4.7) | 8.2 (5.1) | 1.0 (0.1, 2.0) | 0.04 |
| Moderate/high anxiety, No. (%) | 44 (26.5%) | 39 (23.6%) | 38 (22.6%) | 49 (29.3%) | ||||
|
| ||||||||
| Stress (NIH Perceived Stress Scale) b | ||||||||
| Baseline Stress | N=166 | N=165 | N=168 | N=167 | ||||
| Mean (SD) | 60.7 (8.7) | 59.6 (8.6) | 58.5 (7.3) | 59.5 (7.7) | ||||
| Moderate/high stress, No. (%) | 98 (59%) | 85 (51.5%) | 80 (47.6%) | 94 (56.3%) | ||||
| Follow-up Perceived Stress | N=165 | N=159 | N=165 | N=166 | ||||
| Mean (SD) | 56.5 (10.7) | 55.3 (10.1) | 55.1 (9.2) | 57.6 (9.6) | ||||
| Moderate/high stress, No. (%) | 64 (38.6%) | 45 (27.3%) | 59 (35.1%) | 70 (41.9%) | ||||
| Change from baseline | −4.2 (9.3) | −4.4 (8) | −0.2 (−2.1, 1.7) | 0.84 | −3.3 (10.3) | −1.9 (9.9) | 1.5 (−0.7, 3.7) | 0.18 |
|
| ||||||||
| Recent mental health treatment c | N=164 | N=158 | N=164 | N=166 | ||||
| At follow-up, n (%) | 119 (71.7%) | 105 (63.6%) | −4.5% (−15.4%, 6.3%) | 0.41 | 124 (73.8%) | 123 (73.7%) | 5.5% (−5.2%, 16.2%) | 0.31 |
|
| ||||||||
| Increased substance use at follow-up d | ||||||||
| Increased Tobacco use, n/N (%) | 23/163 (14.1%) | 13/152 (8.6%) | −5.6% (−12.5%, 1.4%) | 0.12 | 16/164 (9.8%) | 6/164 (3.7%) | −6.1% (−11.5%, −0.7%) | 0.03 |
| Increased alcohol use, n/N (%) | 42/162 (25.9%) | 38/153 (24.8%) | −1.1% (−10.7%, 8.5%) | 0.83 | 52/164 (31.7%) | 55/162 (34%) | 2.2% (−8.0%, 12.5%) | 0.67 |
| Increased marijuana use, n/N (%) | 15/156 (9.6%) | 19/152 (12.5%) | 2.9% (−4.1%, 9.9%) | 0.42 | 17/156 (10.9%) | 14/159 (8.8%) | −2.1% (−8.7%, 4.5%) | 0.53 |
| Increased illicit drug use, n/N (%) | 7/159 (4.4%) | 3/157 (1.9%) | −2.5% (−6.3%, 1.4%) | 0.2 | 3/159 (1.9%) | 2/165 (1.2%) | −0.7% (−3.4%, 2.0%) | 0.62 |
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| ||||||||
| Safety Outcomes e | N=166 | N=165 | N=168 | N=167 | ||||
| Any death, n (%) | 0 (0%) | 0 (0%) | 1 (0.6%) | 0 (0%) | ||||
| Death by suicide, n (%) | 0 (0%) | 0 (0%) | 1 (0.6%) | 0 (0%) | ||||
| Attempted suicide, n (%) | 0 (0%) | 0 (0%) | 2 (1.2%) | 0 (0%) | ||||
| Interrupted/aborted suicide attempt, n (%) | 0 (0%) | 1 (0.6%) | 3 (1.8%) | 3 (1.8%) | ||||
Symptoms of anxiety were assessed using the GAD-7, a brief self-report scale frequently used in the identification of Generalized Anxiety Disorder. The tool is composed of seven items, which are rated 0–3 to generate a score from 0–21. Higher scores indicate a greater severity of generalized anxiety symptoms. Scores of 11 and higher indicate moderate to high anxiety.
The National Institute of Health (NIH) Toolbox Self-Efficacy Scales Perceived Stress measure is a validated tool to measure the stress and coping resources of an individual. The measure is comprised of ten items which are scored and granted a t-score specific to adult or adolescent participants. Higher t-scores are indicative of higher levels of stress. T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. A T-score of 60.5 or more for adults or 60.8 or more in adolescents indicates moderate to high levels of stress.
Any counseling, therapy, or other mental health treatment in the last 6 months.
Number of participants reporting increased alcohol, tobacco, marijuana, and illicit drug use, measured by questions adapted from Youth Risk Behavior Survey posed in relation to timing of COVID-19 pandemic.
Three elements of the full version of the Columbia Suicide Severity Rating Scale (C-SSRS) (lifetime-recent (baseline) and since last visit (6 months)) were complied to create a Suicide Attempts Survey. These measured self-reported aborted or self-interrupted suicide attempts, interrupted suicide attempts, and actual suicide attempts. Non-lethal self-harm and lethal means used for attempts or completions were also collected. These elements were not included in the C-SSRS score but were compared across the intervention groups. Medical records were used to measure suicide completion.