Mental DisordersNCT01986517
Feedback and Psychotherapeutic Competencies
A study testing No feedback and Feedback after every fourth session in people with Mental Disorders, run by Goethe University at 1 site in Germany.
Trial summary
The purpose of the current study is to examine the influence of feedback on psychotherapeutic competency. The present randomized controlled study compares a feedback condition with a non-feedback condition. Therapists in the feedback condition receive feedback after every fourth session. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- No feedback and Feedback after every fourth session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Mar 2015
- 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 to 65 years
- 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
- Remaining at least 6 month in the ambulance
- Meeting ICD 10 criteria for a mental disorder
- Informed consent
Who cannot join
- -
- Patients
- Currently in psychotherapy
- 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.
Germany1 site
Department of Clinical Psychology and Psychotherapy of Goethe University
Frankfurt am Main, Hesse, 60486
About this study
Official title: Impact of Feedback on the Devolpment of Psychotherapeutic Competencies: a Randomized Controlled Trial
The purpose of the current study is to examine the influence of feedback on psychotherapeutic competency. The present randomized controlled study compares a feedback condition with a non-feedback condition. Therapists in the feedback condition receive feedback after every fourth session. The feedback is given by two trained and independent raters. The raters are licenced and experienced psychotherapists. Therapists in the non-feedback condition receive no feedback during the psychotherapy.
- Conditions
- Mental Disorders
- Being tested
- No feedback, Feedback after every fourth session
- Keywords
- Feedback, Therapeutic competencies, Training
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No feedbackBehavioural
Therapists will receive no feedback.
Feedback after every fourth sessionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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: Feedback after every fourth session |
| No feedback | Experimental | Therapists assigned to this group will receive no feedback Receives: Behavioral: No feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (12)
Helping Alliance Questionaire (HAQ)
self-report measure to assess therapeutic alliance from the therapists perspective (therapist version; HAQ-T) and the patients perspective (HAQ-P)
Measured: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Berner Stundenbögen Version 2000
self-report measure to assess therapeutic relationship from the therapists perspective (therapist version, TSTB) and the patients perspective (patient version; PSTB)
Measured: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Global Assessment of Functioning (GAF)
external measure to assess the global functioning of the patient
Measured: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Supervisory Questionaire (SQ)
self-report measure to assess the therapists self-opening
Measured: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Supervisee Levels Questionaire (SLQ-R)
self-report measure to assess the therapists self-awareness
Measured: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Counseling Self-Estimate Inventory (COSE)
self-report measure to assess self efficacy of the therapist
Measured: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Fear of negative evaluation scale (Skala Angst vor negativer Bewertung; SANB)
self-report measure to assess fear of evaluation
Measured: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Brief Symptom Inventory (BSI)
self-report measure to assess aspects of general psychopathology
Measured: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
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
Beck Anxiety Inventory (BAI)
self-report measure to assess anxiety symptoms
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Weck, Goethe University
- Investigators
- Florian Weck, PhD, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986517
- Sponsor's protocol ID
- Feedback-01
- Status last verified
- Mar 2015
- First submitted
- 11 Nov 2013
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Feedback on the Devolpment of Psychotherapeutic Competencies: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01986517
- Acronym / sponsor ID
- Feedback-01
- Conditions
- Mental Disorders
- Keywords
- Feedback, Therapeutic competencies, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Nov 2013 (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.
The purpose of the current study is to examine the influence of feedback on psychotherapeutic competency. The present randomized controlled study compares a feedback condition with a non-feedback condition. Therapists in the feedback condition receive feedback after every fourth session. The feedback is given by two trained and independent raters. The raters are licenced and experienced psychotherapists. Therapists in the non-feedback condition receive no feedback during the psychotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback | Experimental | Behavioral: Feedback after every fourth sessionTherapists 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. |
| No feedback | Experimental | Behavioral: No feedbackTherapists assigned to this group will receive no feedback |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having successfully completed the interim audit
- Having started to treat ambulant patients
- Remaining at least 6 month in the ambulance
- Meeting ICD 10 criteria for a mental disorder
- Informed consent
Key exclusion criteria (6 listed)
- -
- Patients
- Currently in psychotherapy
- Suicidal tendency
- Clinical diagnosis of alcohol or drug addiction, acute schizophrenia, schizoaffective disorder or bipolar disorder
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 |
|---|---|---|
| No feedbackTherapists will receive no feedback. | Behavioural | No feedback |
| Feedback after every fourth session | Behavioural | Feedback |
Primary outcome
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.
12 secondary outcomes
Helping Alliance Questionaire (HAQ)
Time frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Berner Stundenbögen Version 2000
Time frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Global Assessment of Functioning (GAF)
Time frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Supervisory Questionaire (SQ)
Time frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Supervisee Levels Questionaire (SLQ-R)
Time frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Counseling Self-Estimate Inventory (COSE)
Time frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Fear of negative evaluation scale (Skala Angst vor negativer Bewertung; SANB)
Time frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Brief Symptom Inventory (BSI)
Time frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Beck Depression Inventory II (BDI II)
Time frame: participants will be followed for the duration of psychotherapy, an expected average of 20 weeks
Beck Anxiety Inventory (BAI)
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
Health-related quality of life (SF-12)
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 20 Mar 2015.
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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 principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No feedback and Feedback after every fourth session in people with Mental Disorders, run by Goethe University 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 5 inclusion and 6 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 20 Mar 2015. 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. 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?
Cognitive Therapy Scale (CTS) (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?
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 20 Mar 2015.