- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02479594
Competence-feedback and Therapy Outcome
January 26, 2021 updated by: Florian Weck, Johannes Gutenberg University Mainz
The Importance of Competence-feedback for Therapy Outcome: a Randomized Controlled Trial
In a randomized controlled study design, n = 58 treatments of patients with depression were to be conducted under a feedback-condition, in which the therapist would receive feedback five times within 20 treatment sessions.
The competence-feedback includes detailed feedback about 14 different aspects of therapist behavior.
The control group includes n = 58 further treatments within which therapists do not receive any competence-feedback (treatment as usual; TAU).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Psychotherapeutic competencies are considered to be an important factor for therapy success.
However, empirical studies which have investigated the competence-outcome relationship were only based on correlational analyses.
Therefore, these studies are inappropriate for the investigation of causal relationships.
In previous studies, feedback on therapists' competencies was found to be suitable for enhancing such competencies.
Therefore, in the current research project, competence-feedback should be used to enhance therapeutic competencies systematically, in order to investigate the causal impact of these competencies on therapy outcome.
Using a randomized controlled study design, n = 58 treatments of patients with depression were to be conducted under a feedback-condition, in which the therapist would receive feedback five times within 20 treatment sessions.
The competence-feedback includes detailed feedback about 14 different aspects of therapist behavior.
The control group includes n = 58 further treatments within which therapists do not receive any competence-feedback (treatment as usual; TAU).
In order to ensure comparability of both treatment conditions (regarding an observation situation), the therapists in the TAU condition should also receive feedback, but only after the treatments are finished.
We hypothesize that the feedback-group is superior to the TAU-group and that their treatments lead to significantly better therapy outcome.
Moreover, we use mediator analysis to analyze whether the group-outcome relationship is mediated by therapeutic competencies or by the quality of the therapeutic alliance.
The results are highly relevant for clinical process research, psychotherapy training and for the dissemination of treatment approaches in routine care.
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Mainz, Germany, 55122
- Johannes Gutenberg University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
THERAPISTS
Inclusion Criteria:
- Having successfully completed the interim Audit
- Having started to treat ambulant patients
Exclusion Criteria:
---
PATIENTS
Inclusion Criteria:
- Clinical diagnosis of Major Depression (Meeting DSM-IV criteria)
- Informed consent
Exclusion Criteria:
- Suicidal tendency
- Clinical diagnosis of alcohol or drug addiction, acute schizophrenia, schizoaffective disorder or bipolar disorder
- Clinical diagnosis of personality disorder cluster A (odd disorders) and B (dramatic, emotional or erratic)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: competence-feedback
Therapists assigned to this group will receive standardized feedback on their psychotherapeutic competency after every fourth treatment session with a patient for a period of 20 therapy sessions.
The feedback will be given by two experienced raters who are licensed as psychological psychotherapists.
|
competence-feedback
|
|
Placebo Comparator: control
Therapists assigned to this group will receive no competence-feedback.
|
control group without competence-feedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory II (BDI II)
Time Frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
self-report measure to assess depressive symptoms
|
participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Client Satisfaction Questionaire (CSQ8)
Time Frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
self-report measure to assess satisfaction with therapy
|
participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
|
Health-related quality of life (SF-12)
Time Frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
self-report measure to assess health-related quality of life
|
participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
|
Hamilton Depression Scale (HAMD-17)
Time Frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
external assessment to assess depressive symptoms
|
participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
|
Inventory of Interpersonal Problems (IIP-C)
Time Frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
self-report instrument to identify a person's salient interpersonal difficulties based on the interpersonal circumplex model
|
participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
|
Cognitive Therapy Scale (CTS)
Time Frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
external-assessment measure that assesses psychotherapeutic competency during a cognitive therapy session.
CTS will be used by two trained raters licensed as psychological psychotherapists
|
participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
|
Helping Alliance Questionaire (HAQ)
Time Frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
self-report measure to assess therapeutic alliance from the therapists perspective (therapist version; HAQ-T), the patients perspective (HAQ-P) and the raters perspective (HAQ-R)
|
participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
|
Assessment of Patient Interpersonal Behavior (AFPIB)
Time Frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
assessment of patient in-session interpersonal behavior
|
participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Florian Weck, PhD, University of Potsdam
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
September 1, 2020
Study Completion (Actual)
September 1, 2020
Study Registration Dates
First Submitted
June 19, 2015
First Submitted That Met QC Criteria
June 23, 2015
First Posted (Estimate)
June 24, 2015
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WE_01
- WE 4652/7-1 (Other Grant/Funding Number: German Research foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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