Randomized controlled trial to evaluate the effects of personalized prediction and adaptation tools on treatment outcome in outpatient psychotherapy: Study protocol

Abstract

Background: Psychotherapy is successful for the majority of patients, but not for every patient. Hence, further knowledge is needed on how treatments should be adapted for those who do not profit or deteriorate. In the last years prediction tools as well as feedback interventions were part of a trend to more personalized approaches in psychotherapy. Research on psychometric prediction and feedback into ongoing treatment has the potential to enhance treatment outcomes, especially for patients with an increased risk of treatment failure or drop-out. Methods/design: The research project investigates in a randomized controlled trial the effectiveness as well as moderating and mediating factors of psychometric feedback to therapists. In the intended study a total of 423 patients, who applied for a cognitive-behavioral therapy at the psychotherapy clinic of the University Trier and suffer from a depressive and/or an anxiety disorder (SCID interviews), will be included. The patients will be randomly assigned either to one therapist as well as to one of two intervention groups (CG, IG2). An additional intervention group (IG1) will be generated from an existing archival data set via propensity score matching. Patients of the control group (CG; n = 85) will be monitored concerning psychological impairment but therapists will not be provided with any feedback about the patients assessments. In both intervention groups (IG1: n = 169; IG2: n = 169) the therapists are provided with feedback about the patients self-evaluation in a computerized feedback portal. Therapists of the IG2 will additionally be provided with clinical support tools, which will be developed in this project, on the basis of existing systems. Therapists will also be provided with a personalized treatment recommendation based on similar patients (Nearest Neighbors) at the beginning of treatment. Besides the general effectiveness of feedback and the clinical support tools for negatively developing patients, further mediating and moderating variables on this feedback effect should be examined: treatment length, frequency of feedback use, therapist effects, therapist's experience, attitude towards feedback as well as congruence of therapist's and patient's evaluation concerning the progress. Additional procedures will be implemented to assess treatment adherence as well as the reliability of diagnosis and to include it into the analyses. Discussion: The current trial tests a comprehensive feedback system which combines precision mental health predictions with routine outcome monitoring and feedback tools in routine outpatient psychotherapy. It also adds to previous feedback research a stricter design by investigating another repeated measurement CG as well as a stricter control of treatment integrity. It also includes a structured clinical interview (SCID) and controls for comorbidity (within depression and anxiety). This study also investigates moderators (attitudes towards, use of the feedback system, diagnoses) and mediators (therapists' awareness of negative change and treatment length) in one study. Trial registration: Current Controlled Trials NCT03107845. Registered 30 March 2017.