NCT02479594

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

5.1 years

First QC Date

June 19, 2015

Last Update Submit

January 26, 2021

Conditions

Depression

Keywords

competence-feedback

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Hamilton Depression Scale (HAMD-17)

    participants will be followed for the duration of psychotherapy, an expected average of 20 weeks

  • Inventory of Interpersonal Problems (IIP-C)

    participants will be followed for the duration of psychotherapy, an expected average of 20 weeks

  • Health-related quality of life (SF-12)

    participants will be followed for the duration of psychotherapy, an expected average of 20 weeks

  • Client Satisfaction Questionaire (CSQ8)

    participants will be followed for the duration of psychotherapy, an expected average of 20 weeks

  • Cognitive Therapy Scale (CTS)

    participants will be followed for the duration of psychotherapy, an expected average of 20 weeks

  • +2 more secondary outcomes

Study Arms (2)

competence-feedback

EXPERIMENTAL

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

control

PLACEBO COMPARATOR

Therapists assigned to this group will receive no competence-feedback.

Other: control

Interventions

competence-feedbackBEHAVIORAL

competence-feedback

competence-feedback
controlOTHER

control group without competence-feedback

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having successfully completed the interim Audit
  • Having started to treat ambulant patients

You may not qualify if:

  • \---
  • PATIENTS
  • Clinical diagnosis of Major Depression (Meeting DSM-IV criteria)
  • Informed consent
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Gutenberg University

Mainz, 55122, Germany

Location

Related Publications (2)

  • Maass U, Witthoft M, Junga YM, Hahn D, Weck F. Relationships Among Patients' Interpersonal Behaviors in Sessions, Therapist Competence, and the Therapeutic Alliance in Cognitive Behavior Therapy: A Cross-Lagged Panel Analysis. J Clin Psychol. 2026 Jan;82(1):18-30. doi: 10.1002/jclp.70040. Epub 2025 Aug 30.

    PMID: 40884452DERIVED

  • Weck F, Junga YM, Kliegl R, Hahn D, Brucker K, Witthoft M. Effects of competence feedback on therapist competence and patient outcome: A randomized controlled trial. J Consult Clin Psychol. 2021 Nov;89(11):885-897. doi: 10.1037/ccp0000686.

    PMID: 34881909DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Florian Weck, PhD

    University of Potsdam

    STUDY DIRECTOR

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
Director of studies

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 24, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)