DepressionNCT02479594
Competence-feedback and Therapy Outcome
A study testing competence-feedback in people with Depression, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- competence-feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having successfully completed the interim Audit
- Having started to treat ambulant patients
- Clinical diagnosis of Major Depression (Meeting DSM-IV criteria)
- Informed consent
Who cannot join
- ---
- PATIENTS
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Depression
- Being tested
- competence-feedback, control
- Keywords
- competence-feedback
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
competence-feedbackBehavioural
competence-feedback
controlOther
control group without competence-feedback
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: competence-feedback |
| control | Placebo comparator | Therapists assigned to this group will receive no competence-feedback. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory II (BDI II)
self-report measure to assess depressive symptoms
Measured: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Secondary outcomes (7)
Hamilton Depression Scale (HAMD-17)
external assessment to assess depressive symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Potsdam
- Responsible party
- Principal investigator, Florian Weck, University of Potsdam
- Investigators
- Florian Weck, PhD, Study director, University of Potsdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479594
- Sponsor's protocol ID
- WE_01
- Other IDs
- WE 4652/7-1
- Status last verified
- Jan 2021
- First submitted
- 19 Jun 2015
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 40884452Weck 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.
PubMed 34881909
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Competence-feedback for Therapy Outcome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02479594
- Acronym / sponsor ID
- WE_01
- Conditions
- Depression
- Keywords
- competence-feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- University of Potsdam
- Study start
- Aug 2015
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| competence-feedback | Experimental | Behavioral: competence-feedbackTherapists 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. |
| control | Placebo comparator | Other: controlTherapists assigned to this group will receive no competence-feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having successfully completed the interim Audit
- Having started to treat ambulant patients
- Clinical diagnosis of Major Depression (Meeting DSM-IV criteria)
- Informed consent
Key exclusion criteria (5 listed)
- ---
- PATIENTS
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| competence-feedbackcompetence-feedback | Behavioural | competence-feedback |
| controlcontrol group without competence-feedback | Other | control |
Primary outcome
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
7 secondary outcomes
Hamilton Depression Scale (HAMD-17)
Time frame: 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
Health-related quality of life (SF-12)
Time frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Client Satisfaction Questionaire (CSQ8)
Time frame: 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
Helping Alliance Questionaire (HAQ)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Derived from this study: PubMed 40884452Maass 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.
- Derived from this study: PubMed 34881909Weck 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Weck, PhD study director
University of Potsdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing competence-feedback in people with Depression, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory II (BDI II) (time frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02479594, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.