Routine process and outcome monitoring interventions added to psychotherapy are known to improve treatment outcomes, although they vary in format and effectiveness. This study aimed to evaluate whether a therapist-independent, internet-based routine process monitoring and feedback system could significantly reduce psychological distress and enhance the quality of the therapeutic relationship compared with a treatment-as-usual control group among individuals already engaged in individual psychotherapy. We randomized 475 participants into either the intervention group, which received access to an internet-based routine process monitoring and feedback system in addition to psychotherapy, or the control group, which received only psychotherapy. The trial lasted for 10 weeks. Follow-up assessments at 5 weeks and 10 weeks used the Clinical Outcomes in Routine Evaluation-Outcome Measure as the primary outcome, with the Working Alliance Inventory-Short Revised and the Real Relationship Inventory-Client form as secondary outcomes. Per-protocol analyses (n=166) showed that psychological distress decreased in both groups, but there was no significant advantage for the intervention group. The intervention group experienced a decline in the genuineness dimension score of the real relationship, with an effect size of d=-0.27, compared with d=0.01 in the control group. In the intervention group (but not in the control group), dropouts showed significantly lower real relationship levels (P=.002), working alliance quality (P=.051), and emotional disclosure (P=.01) compared with those who completed the study. Additionally, logistic regression revealed distinct predictors of dropout within the control group and intervention group. The findings do not provide conclusive evidence for the efficacy of the new internet-based intervention in enhancing self-monitoring and prompting reflection on patients' emotional responses to their therapists. However, the intervention appears to influence patients' perceptions of the genuineness dimension in the therapeutic relationship, warranting further investigation. We hypothesize that this alteration in the genuineness dimension could be attributed to the intervention facilitating a more realistic and accurate perception of the therapeutic relationship among participants. ClinicalTrials.gov NCT06038747; https://clinicaltrials.gov/study/NCT06038747. RR2-10.2196/55369.
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