Table 3. Results of analysis of secondary endpoints (binary) after 6 months.
| COMET | TAU | COMET vs. TAU | ||||||
| n/N | % | n/N | % | Adjusted odds ratios (95% CI) | P-value | Group × time interaction*3 | ICC | |
| PHQ-panic module | 23/36 | 63.9 | 12/17 | 70.6 | 0.47 [0.21, 1.07] | 0.071 | 0.823 | 0.020 |
| Disorder-specific remission*1 | ||||||||
| Severity of depression, PHQ-9 | 49/187 | 26.2 | 61/168 | 36.3 | 0.86 [0.47, 1.54] | 0.604 | – | 0.043 |
| Severity of anxiety, GAD-7 | 65/187 | 34.8 | 86/168 | 51.2 | 0.61 [0.32, 1.17] | 0.139 | 0.000 | 0.000 |
| Severity of somatic symptoms, PHQ-15 | 91/187 | 48.7 | 100/168 | 59.5 | 0.54 [0.24, 1.22] | 0.137 | 0.000 | 0.045 |
| Mental burden related to somatic symptoms, SSD-12 | 87/107 | 81.3 | 83/103 | 80.6 | 1.63 [0.75, 3.51] | 0.216 | – | 0.000 |
| Symptoms of alcohol-related disorder, AUDIT-C | 160/190 | 84.2 | 129/169 | 76.3 | 2.63 [1.48, 4.67] | 0.001 | 0.265 | 0.000 |
| Disorder-specific response*2 | ||||||||
| Severity of depression, PHQ-9 | 85/186 | 45.7 | 77/167 | 46.1 | 0.79 [0.43, 1.46] | 0.450 | 0.000 | 0.003 |
| Severity of anxiety, GAD-7 | 96/186 | 51.6 | 87/164 | 53.1 | 0.79 [0.50, 1.23] | 0.291 | – | 0.000 |
| Severity of somatic symptoms, PHQ-15 | 75/186 | 40.3 | 65/167 | 38.9 | 1.09 [0.66, 1.78] | 0.739 | 0.055 | 0.022 |
| Psychological burden related to somatic symptoms, SSD-12 | 37/104 | 35.6 | 31/98 | 31.6 | 1.48 [0.69, 3.21] | 0.315 | 0.004 | 0.000 |
| Symptoms of alcohol-related disorder, AUDIT-C | 60/157 | 38.2 | 46/144 | 31.9 | 1.83 [1.16, 2.90] | 0.010 | 0.439 | 0.000 |
Results are presented as n/N (events/sample size), %, and adjusted odds ratios (OR) with 95% CI using the ITT sample for patients with at least one follow-up measurement after baseline.
*1 Remission = value below clinical cut-off values on disorder-specific instruments: PHQ-9 score < 5, GAD-7 score < 5, PHQ-15 score < 9, SSD-12 score < 23, and AUDIT-C < 4 (women)/< 5 (men)
*2 Response = at least 50% reduction on disorder specific instruments
*3 An interaction p-value above 0.05 means that the intervention effect is the same for all time points; otherwise, a time-dependent intervention effect is present. No relevant group differences in remission and response were observed, except for marginal indications of potential group differences in symptoms of alcohol-related disorder in favor of the COMET group; this effect was independent of time.
AUDIT-C, Alcohol Use Disorders Identification Test; CI, confidence interval; COMET, intervention group; GAD-7, Generalized Anxiety Disorder Scale-7; ICC, Intraclass Correlation Coefficient (variance of practices divided by total variance); PHQ-9, Patient Health Questionnaire-9; PHQ-15, Patient Health Questionnaire-15; SSD-12, Somatic Symptom Disorder-B Criteria Scale; TAU, control group, treatment as usual