Comparative ITT Analysis of Intervention vs Control Groups: Impact on Outcomes and Adherence at 6 Months
| Outcomes | CTIC Group | UT Group | Comparison | Intracluster Coefficient | ||||
|---|---|---|---|---|---|---|---|---|
| No. | Mean (SD) | No. | Mean (SD) | AMD (95% CI) P Value | Effect Size (95% CI) | Baseline | 6 months | |
| Primary | ||||||||
| PHQ-9a | 115 | 8.9 (6.6) | 99 | 12.2 (8.1) | −3.09 (−4.94 to −1.23) .001 | −0.46 (−073 to −0.18) | 0.06 | 0.10 |
| Secondary | ||||||||
| GAD-7b | 115 | 9.3 (5.7) | 99 | 10.8 (6.3) | − 1.50 (− 3.03 to 0.31) .055 | −0.25 (−0.52 to 0.02) | 0.05 | 0.05 |
| DERSc | 113 | 64.6 (25.0) | 96 | 69.3 (25.6) | −2.40 (−8.35 to 3.54) .427 | −0.19 (−0.46 to 0.09) | 0.06 | 0.08 |
| OQ-45.2 IRd | 114 | 19.1 (9.4) | 98 | 19.7 (8.1) | −1.12 (−3.27 to 1.03) .307 | −0.06 (−0.34 to 0.20) | 0.12 | 0.08 |
| OQ-45.2 SRe | 114 | 11.4 (6.2) | 98 | 12.8 (6.5) | −1.26 (−2.81 to 0.29) .112 | −0.21 (−0.48 to 0.06) | 0.07 | 0.06 |
| GHASf | 104 | 31.7 (9.9) | 79 | 29.0 (9.8) | 2.59 (1.82 to 4.99) .035 | −0.00 (−0.43 to 0.30) | 0.10 | 0.11 |
AMD = adjusted mean difference; CTIC = collaborative trauma-informed care; DERS = difficulties in emotional regulation scale; GAD = generalized anxiety disorder; GHAS = general health adherence scale; IP = interpersonal; ITT = intention to treat; OQ = outcome questionnaire; PHQ= patient health questionnaire; SR = social role; UT = usual treatment.
NOTE: The CTIC group was the intervention, and the UT group, the control.
↵a PHQ-9 score range = 0-27; 7 or more indicates depressive symptoms.
↵b GAD-7 score range =0-23; 10 or more indicates anxiety symptoms.
↵c DERS score range = 0-140; 73 or more indicates emotion dysregulation.
↵d OQ45.2 PI subscale score range = 0-48; 16 or more indicates interpersonal dysfunctions.
↵e OQ45.2 SR subscale score range = 0-36; 14 or more indicates social dysfunctions.
↵f GHAS score range = 0-36; 24 or less is low, 25-30 is moderate, and 31 or more is high adherence.