Randomized Controlled Trial to Evaluate Personalized Prediction and Adaptation Tools in Psychotherapy
Condition: Feedback, Psychological
Study type: Interventional

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.
    

Detailed description: 
      The primary objective of the current project is to investigate several questions of feedback
      research in psychotherapy with a cluster randomized controlled trial (RCT) with two feedback
      groups (IG1: Feedback; IG2: Feedback plus CSTs) and one CG with repeated measurements. IG1
      will be generated from an existing archival data set via propensity score matching. It 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).
      Furthermore, a more severely impaired patient sample is studied and an international outcome
      instrument is used, which is also often applied in outpatient centers in Germany. This study
      also investigates the above described moderators (attitudes towards, use of the feedback
      system, diagnoses) and mediators (therapists' awareness of negative change and treatment
      length) in a comprehensive model and in one study.

      Therefore, the research questions are:

      Main questions:

      H1: NOT patients in the feedback condition (IG1) show on average better treatment outcome
      than NOT patients in the CG.

      H2: NOT patients in the IG2 (+CSTs) show on average better treatment outcomes than NOT
      patients of the IG1 (no CSTs but psychometric feedback).

      Secondary questions concerning moderators and mediators:

      H3: The positive impact of feedback for NOT patients is moderated through the usage of the
      feedback system and/or the attitudes of the therapist towards feedback.

        -  H3a: The more frequently and the longer feedback is used, the more aware are therapists
           for negative change.

        -  H3b: The more positive the therapists' attitudes towards, the more aware are therapists
           for negative change.

        -  H3c: The effects of feedback on patient outcomes do not differ between diagnostic groups
           (depression and anxiety).

      H4: The positive impact of feedback for NOT patients is mediated through therapists'
      awareness of negative change as well as treatment length

        -  H4a: The positive impact of feedback for NOT patients is mediated by the therapists'
           awareness of negative developments of patients.

        -  H4b: The positive effect of therapists' awareness on treatment outcome is mediated by
           treatment length (number of sessions).

      It is assumed that feedback raises therapists' awareness of negative change. This increased
      awareness could directly improve treatment outcome through a respective treatment adaption.
      Given the finding that NOT patients tend to have longer treatments when therapists receive
      feedback, this effect of increased awareness on treatment outcome could be mediated through
      treatment length. Accordingly, the essential adaption after being aware of a negative
      progress would be a higher number of sessions which gives NOT patients more time to improve.
      However, other adaptions than an increased treatment length are possible and could directly
      enhance treatment outcome. Regarding the above described moderators it is assumed that the
      amount of feedback induced awareness as well as the positive effect of feedback on outcome is
      potentially influenced by therapists' attitude towards feedback, the usage of the feedback
      system and diagnoses.

      Furthermore, effects of feedback are controlled for the following potential influence
      factors: treatment integrity (adherence, competence), comorbidity, initial impairment,
      clinical experience as well as experience with the feedback system, non-psychometric feedback
      and therapist effects (Level 2 variable).

      To answer these questions, the following treatment and CSTs will be studied in the outpatient
      clinic at the University of Trier:

        -  Control group (CG): Treatment with continuous assessments but without computer based
           feedback to therapists.

        -  Intervention group 1(IG1): Treatment with continuous assessments including computer
           based feedback to therapists after each session. This group is a matched sample.

        -  Intervention group 2(IG2): Treatment with continuous assessments including computer
           based feedback to therapists after each session including an alarm for NOT patients and
           the provision of CST for NOT patients.
    

Intervention name(s): Cognitive Behavior Therapy; CBT plus Feedback; CBT plus Feedback plus CST
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CBT; Psychometric Feedback; Clinical Support Tools; Personalized Mental Health