Competence-feedback and Therapy Outcome

Study Overview
=================
Brief Summary
-----------------
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).

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.

Official Title
-----------------
The Importance of Competence-feedback for Therapy Outcome: a Randomized Controlled Trial

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: competence-feedback
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: competence-feedback<br>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. | Behavioral: competence-feedback<br>* competence-feedback<br>|
| Placebo Comparator: control<br>Therapists assigned to this group will receive no competence-feedback. | Other: control<br>* control group without competence-feedback<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory II (BDI II) | 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 |
| --- | --- | --- |
| Hamilton Depression Scale (HAMD-17) | 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) | 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 | 
| Health-related quality of life (SF-12) | 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 | 
| Client Satisfaction Questionaire (CSQ8) | self-report measure to assess satisfaction with therapy | participants will be followed for the duration of psychotherapy, an expected average of 20 weeks | 
| Cognitive Therapy Scale (CTS) | 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) | 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) | assessment of patient in-session interpersonal behavior | participants will be followed for the duration of psychotherapy, an expected average of 20 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
competence-feedback