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

NCT03107845 | Completed

• 1 other identifier: LU 660/10-1
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

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.

Conditions

Feedback, Psychological

Keywords

CBT; Psychometric Feedback; Clinical Support Tools; Personalized Mental Health

Outcome Measures

Primary Outcomes (1)

• Change in 11-item Short version of Hopkins' Symptom Checklist (HSCL-11; Lutz, Tholen, Schürch, & Berking, 2006)

  The mean of the HSCL-11 is used as the main outcome measure administered before each session.

  through study completion, an average of 50 weeks

Secondary Outcomes (4)

• Change in Outcome Questionnaire (OQ-30; Lambert et al., 1996)

  through study completion, an average of 50 weeks

• Change in Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)

  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

• Change in the Brief Symptom Inventory (BSI; Franke, 2000)

  through study completion, an average of 50 weeks

Study Arms (3)

Cognitive Behavior Therapy

ACTIVE COMPARATOR

Cognitive Behavioral Therapy without psychometric Feedback.

Behavioral: Cognitive Behavior Therapy

CBT plus Feedback

EXPERIMENTAL

Cognitive Behavioral Therapy (CBT) with Psychometric Feedback

Behavioral: CBT plus Feedback

CBT plus Feedback plus CST

EXPERIMENTAL

Cognitive Behavioral Therapy (CBT) with Psychometric Feedback and Clinical Support Tools (CST)

Behavioral: CBT plus Feedback plus CST

Interventions

Cognitive Behavior Therapy BEHAVIORAL

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.

Cognitive Behavior Therapy

CBT plus Feedback BEHAVIORAL

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.

CBT plus Feedback

CBT plus Feedback plus CST BEHAVIORAL

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.

CBT plus Feedback plus CST

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One anxiety and/or depressive disorder (ICD-10: F32, F33, F40, F41, F42, F43)
• At least 3 treatment sessions

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Trier: lead
• German Research Foundation: collaborator

Study Sites (1)

University of Trier

Trier, Rhineland-Palatinate, 54296, Germany

Location

Related Publications (3)

• Lutz W, De Jong K, Rubel J. Patient-focused and feedback research in psychotherapy: Where are we and where do we want to go? Psychother Res. 2015;25(6):625-32. doi: 10.1080/10503307.2015.1079661. Epub 2015 Sep 16.

  PMID: 26376225 BACKGROUND

• Lutz W, Rubel J, Schiefele AK, Zimmermann D, Bohnke JR, Wittmann WW. Feedback and therapist effects in the context of treatment outcome and treatment length. Psychother Res. 2015;25(6):647-60. doi: 10.1080/10503307.2015.1053553. Epub 2015 Jul 28.

  PMID: 26218788 BACKGROUND

• Lutz W, Zimmermann D, Muller VNLS, Deisenhofer AK, Rubel JA. Randomized controlled trial to evaluate the effects of personalized prediction and adaptation tools on treatment outcome in outpatient psychotherapy: study protocol. BMC Psychiatry. 2017 Aug 24;17(1):306. doi: 10.1186/s12888-017-1464-2.

  PMID: 28836954 DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy; galactosylceramide sulfotransferase

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Wolfgang Lutz, Prof. Dr.

  University of Trier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Wolfgang Lutz

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 11, 2017
• Study Start: April 15, 2017
• Primary Completion: October 15, 2019
• Study Completion: May 1, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)