Randomized Controlled Trial to Evaluate Personalized Prediction and Adaptation Tools in Psychotherapy

Summary

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 archivale 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.

Conditions

• Feedback, Psychological

Interventions

BEHAVIORAL

Cognitive Behavior Therapy

Treatments are conducted by cognitive-behavioral therapists in training with different levels of experience as well as licensed cognitive-behavioral therapists with several years of experience. The treatment approach is based on cognitive-behavioral manuals and principles.

BEHAVIORAL

CBT plus Feedback

Therapists of the IG1 are provided with information about the initial status concerning symptoms (BSI \& OQ-30), interpersonal functioning (IIP-32 \& OQ-30) as well as diagnoses specific symptoms (GAD-7 or PHQ-9). Beside the status measures, also individual progress information on the symptom level (HSCL-11 each session) is provided to the therapist. Randomized controlled trial to evaluate the effects of personalized prediction and adaptation tools on treatment outcome in outpatient psychotherapy. This group is a matched sample.

BEHAVIORAL

CBT plus Feedback plus CST

Additional to the intervention group "CBT and Feedback" therapists will be provided with additional clinical support tools (CST) which are designed to facilitate treatment selection and treatment adaptation. The causes of deterioration will be assessed and therapists will be provided with additional treatment recommendations and material to help preventing treatment failure for a specific patient. During treatment the clinical support tools will be provided in the problem fields: risk/suicidality, motivation / treatment goals, therapeutic relationship, social support / critical life events, and emotion regulation / self regulation.

Sponsors & Collaborators

• German Research Foundation

  collaborator OTHER

• University of Trier

  lead OTHER

Principal Investigators

• Wolfgang Lutz, Prof. Dr. · University of Trier

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-15

Primary Completion

2019-10-15

Completion

2020-05-01

Countries

• Germany

Study Locations