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

Wolfgang Lutz, Dirk Zimmermann, Viola N L S Müller, Anne-Katharina Deisenhofer, Julian A Rubel, Wolfgang Lutz, Dirk Zimmermann, Viola N L S Müller, Anne-Katharina Deisenhofer, Julian A Rubel

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.

Keywords: Feedback; Moderators and mediators; Personalized mental health; Precision mental health; Routine outcome monitoring.

Conflict of interest statement

Ethics approval and consent to participate

The ethics committee of the University of Trier approved the execution of the study. The ethical approval was also accepted by the German research foundation.

Patient informed consent: Prior to study participation, all patients receive written and oral information in the Patient Information Sheet about the content and extent of the planned study. This includes information about the treatment and the information that all treatment sessions are videotaped. Patients who agree to participate are required to sign the informed consent form.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The mediating and moderating role of variables in the effect of feedback on treatment outcome (path c)
Fig. 2
Fig. 2
Diagram of patient flow within the study
Fig. 3
Fig. 3
Progress of two different simulated patient examples measured with the HSCL-11. On the left, a negatively developing patient who went off-track during the course of treatment and on the right side a positively developing patient who stays on-track after session 10
Fig. 4
Fig. 4
Personalized strategy recommendations and nearest neighbor therapists
Fig. 5
Fig. 5
Example screenshot from the feedback system in the IG2. All orange signals within the box are linked to respective adaptation and problem solving tools. For therapists in the IG1 neither the signals in the red box nor the access to the tools will be included

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