Randomized Controlled Trial to Evaluate the Effects of Psychometric Feedback on Treatment Outcome and Its Mediators and Moderators in Outpatient Psychotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 423
- Locations
- 2
- Primary Endpoint
- Change in 11-item Short version of Hopkins' Symptom Checklist (HSCL-11; Lutz, Tholen, Schürch, & Berking, 2006)
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •One anxiety and/or depressive disorder (ICD-10: F32, F33, F40, F41, F42, F43)
- •At least 3 treatment sessions
Exclusion Criteria
- •Organic, including symptomatic mental disorders (ICD-10: F00-F09)
- •Mental and behavioral disorders due to psychoactive substances (ICD-10: F10-F19)
- •Schizophrenia, schizotypal, and delusional disorders (ICD-10: F20-F29)
- •Acute suicidality
Outcomes
Primary Outcomes
Change in 11-item Short version of Hopkins' Symptom Checklist (HSCL-11; Lutz, Tholen, Schürch, & Berking, 2006)
Time Frame: through study completion, an average of 50 weeks
The mean of the HSCL-11 is used as the main outcome measure administered before each session.
Secondary Outcomes
- Change in Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)(through study completion, an average of 50 weeks)
- Change in the Brief Symptom Inventory (BSI; Franke, 2000)(through study completion, an average of 50 weeks)
- Change in Outcome Questionnaire (OQ-30; Lambert et al., 1996)(through study completion, an average of 50 weeks)
- Change in Generalized Anxiety Disorder (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)(through study completion, an average of 50 weeks)
Investigators
Prof. Dr. Wolfgang Lutz
Prof. Dr. Wolfgang Lutz
University of Trier