Negative Therapy ExpectationNCT03594903
Maintenance (vs. Change) of Critical Attitudes Towards Psychotherapy
A study testing video intervention (therapy expectation violation) and video intervention (symptoms+ expectation) in people with Negative Therapy Expectation, run by Philipps University Marburg.
Trial summary
The aim of the study is to evaluate the effectiveness of a video intervention, which was designed to improve therapy expectation of persons with critical attitudes towards psychotherapy via violating their expectations about therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Negative Therapy Expectation
- What is being tested?
- video intervention (therapy expectation violation) and video intervention (symptoms+ expectation)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Jan 2019
- 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
- Age: 18 years or older
- Critical attitude towards psychotherapy (self-selection)
- ability to speak and read German
- access to the internet
Who cannot join
- known major mental disorder, such as schizophrenia or another psychotic disorder, or drug or alcohol addiction or dementia (based on self-report)
- medication that influences cognitive processes substantially (benzodiazepine)
About this study
The aim of the study is to evaluate the effectiveness of a video intervention, which was designed to improve therapy expectation of persons with critical attitudes towards psychotherapy via violating their expectations about therapy. Therefore, 120 participants will be recruited and randomized to two groups:
(1) An experimental group that is watching a video with patients (actors) that are giving oral information about their therapy and the mostly positive therapy outcome, (2) a control group that is watching a video with the same patients before therapy or after the first therapy session who are giving information about symptoms and their expectation on therapy. The primary outcome is the Milwaukee Psychotherapy Expectation Questionnaire (MPEQ) collected before and after the video.
Read the detailed description
Therapy expectation is one of the main predictors of therapy outcome. This could be shown through many results in the medical sector as well as in studies that are focusing on psychotherapeutic interventions across different mental disorders. Although psychotherapy is a successful treatment for many disorders it is still hold in low esteem by some parts of the population and from some patient groups in particular. This can cause (that) patients who are in need of treatment not being recommended to the right therapy. Furthermore patients with low therapy expectation are more likely to (prematurely) abandon their therapy or having a lower therapy outcome. So therapy expectation should definitely be addressed in the very first therapy sessions because of it´s high impact.
The Violex-model gives an overview on how expectations in general are developed, maintained or modified. The model postulates that a process called immunization can lead to maintenance of expectation even if they receive information that contradicts their expectation. However no trial has yet examined weather the suggestions of the model are adaptable to therapy expectation. Therefore the investigators are recruiting participants with critical attitudes towards psychotherapy and trying to provoke expectation violation via an online experiment containing videos with patients reporting about their mostly positive outcome of psychotherapy. A control group is watching a video with patients who are just giving information about their symptoms and their first impressions on psychotherapy. The primary outcome is the Milwaukee Psychotherapy Expectation Questionnaire (MPEQ) collected before and after the video. Furthermore the participants are asked about their attitudes towards psychotherapeutic treatment (QAPT, German Version FEP), their own experience with psychotherapy and experiences of relevant others, behavioral intensions towards seeking psychotherapy, their mental wellbeing and demographic data. Before watching the video participants are also asked to formulate one to three individual expectations on psychotherapy. After watching the video they are asked how much they still believe in their individual expectation.
The investigators are aiming to modify low therapy expectation by generating expectation violation and paying particular attention to the issue of persistence of expectations via having a closer look on possible immunization strategies. For doing so they developed immunization items (data- and construct-orientated) that are shown at the end of the experiment.
- Conditions
- Negative Therapy Expectation
- Being tested
- video intervention (therapy expectation violation), video intervention (symptoms+ expectation)
- Keywords
- therapy expectation, therapy motivation, critical attitudes towards psychotherapy, expectation violation, Violex model, psychological online-experiment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video intervention (therapy expectation violation)Behavioural
The investigators asked experts (psychotherapist and scientists in the area of clinical psychology) about typical therapy expectation violations in therapy and searched the literature for information about typical therapy processes and outcomes. Having these information they designed a script for the experimental video. The patients in the video are played by actors aged from 28 to 58 years (two male and two female actors). Patients are representing common mental disorders (depression, anxiety disorder, alcohol addiction, depression after physical disease). The abbreviated name, age and disorder of the patients is displayed for 3 seconds in the video. The patients are giving information about the mostly positive outcome and the process of their therapy. All participants are watching a video with all patients (7 minutes). The videos (control and experimental group) have been evaluated by 12 experts (psychotherapist and scientists in the area of clinical psychology).
video intervention (symptoms+ expectation)Behavioural
Participants in the control group are watching a video with the same patients (actors) as in the experimental video. In this video patients are shown before or after the first therapy session. They are giving information about symptoms and their expectation on therapy but NOT about therapy outcome.
| Study group | Role | What they receive |
|---|---|---|
| Expectation violation (positive outcome of therapy) | Experimental | Experimental: patients' report about therapy outcome Video with patients giving information about (mostly) positive therapy outcome Receives: Behavioral: video intervention (therapy expectation violation) |
| Control group (symptoms + expectation) | Other | Control group: patient´s report about symptoms and therapy expectations
Participants in the control group are watching a video with the same patients (actors) as in the experimental video. In this video patients are shown before or after the first therapy session. They are giving information about symptoms and their expectation on therapy but NOT about therapy outcome. Receives: Behavioral: video intervention (symptoms+ expectation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Milwaukee Expectation Questionnaire (MPEQ)
Therapy expectation measured by the Milwaukee Expectation Questionnaire (MPEQ) - 13 items, German translation, self-report, subscales: process expectation and outcome expectation, total mean from min. 0 to max.10.
Measured: changes from baseline to after watching the video (approx. 20 minutes later)
Secondary outcomes (3)
FEP/ QAPT
Self-report measure of attitudes towards psychotherapeutic treatments FEP (Fragebogen zu Einstellungen gegenüber der Inanspruchnahme psychotherapeutischer Hilfe) / Attitudes towards Psychotherapeutic Treatment (QAPT); total score from min. 11 to max. 44
Measured: changes from baseline to after watching the video (approx. 20 minutes later)
Self-report of individual expectations towards psychotherapy; mean from min. 1 to max. 7
Measured: changes from baseline to after watching the video (approx. 20 minutes later)
Self-report of behavioral intensions towards seeking psychotherapy (self-developed items); mean from min. 1 to max.7
Measured: changes from baseline to after watching the video (approx. 20 minutes later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study startNov 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Negative Therapy ExpectationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants are assigned to one of two groups in parallel for the duration of the study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594903
- Sponsor's protocol ID
- 2018-19k
- Status last verified
- Nov 2018
- First submitted
- 5 Jul 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Braun-Koch K, Rief W. Maintenance vs. Change of Negative Therapy Expectation: An Experimental Investigation Using Video Samples. Front Psychiatry. 2022 Apr 4;13:836227. doi: 10.3389/fpsyt.2022.836227. eCollection 2022.
PubMed 35444567
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance (vs. Change) of Critical Attitudes Towards Psychotherapy
- ClinicalTrials.gov ID
- NCT03594903
- Acronym / sponsor ID
- 2018-19k
- Conditions
- Negative Therapy Expectation
- Keywords
- therapy expectation, therapy motivation, critical attitudes towards psychotherapy, expectation violation, Violex model, psychological online-experiment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 20 Jul 2018 (actual)
- 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 aim of the study is to evaluate the effectiveness of a video intervention, which was designed to improve therapy expectation of persons with critical attitudes towards psychotherapy via violating their expectations about therapy. Therefore, 120 participants will be recruited and randomized to two groups:
(1) An experimental group that is watching a video with patients (actors) that are giving oral information about their therapy and the mostly positive therapy outcome, (2) a control group that is watching a video with the same patients before therapy or after the first therapy session who are giving information about symptoms and their expectation on therapy. The primary outcome is the Milwaukee Psychotherapy Expectation Questionnaire (MPEQ) collected before and after the video.
Detailed description
Therapy expectation is one of the main predictors of therapy outcome. This could be shown through many results in the medical sector as well as in studies that are focusing on psychotherapeutic interventions across different mental disorders. Although psychotherapy is a successful treatment for many disorders it is still hold in low esteem by some parts of the population and from some patient groups in particular. This can cause (that) patients who are in need of treatment not being recommended to the right therapy. Furthermore patients with low therapy expectation are more likely to (prematurely) abandon their therapy or having a lower therapy outcome. So therapy expectation should definitely be addressed in the very first therapy sessions because of it´s high impact.
The Violex-model gives an overview on how expectations in general are developed, maintained or modified. The model postulates that a process called immunization can lead to maintenance of expectation even if they receive information that contradicts their expectation. However no trial has yet examined weather the suggestions of the model are adaptable to therapy expectation. Therefore the investigators are recruiting participants with critical attitudes towards psychotherapy and trying to provoke expectation violation via an online experiment containing videos with patients reporting about their mostly positive outcome of psychotherapy. A control group is watching a video with patients who are just giving information about their symptoms and their first impressions on psychotherapy. The primary outcome is the Milwaukee Psychotherapy Expectation Questionnaire (MPEQ) collected before and after the video. Furthermore the participants are asked about their attitudes towards psychotherapeutic treatment (QAPT, German Version FEP), their own experience with psychotherapy and experiences of relevant others, behavioral intensions towards seeking psychotherapy, their mental wellbeing and demographic data. Before watching the video participants are also asked to formulate one to three individual expectations on psychotherapy. After watching the video they are asked how much they still believe in their individual expectation.
The investigators are aiming to modify low therapy expectation by generating expectation violation and paying particular attention to the issue of persistence of expectations via having a closer look on possible immunization strategies. For doing so they developed immunization items (data- and construct-orientated) that are shown at the end of the experiment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- participants are assigned to one of two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Expectation violation (positive outcome of therapy) | Experimental | Behavioral: video intervention (therapy expectation violation)Experimental: patients' report about therapy outcome Video with patients giving information about (mostly) positive therapy outcome |
| Control group (symptoms + expectation) | Other | Behavioral: video intervention (symptoms+ expectation)Control group: patient´s report about symptoms and therapy expectations Participants in the control group are watching a video with the same patients (actors) as in the experimental video. In this video patients are shown before or after the first therapy session. They are giving information about symptoms and their expectation on therapy but NOT about therapy outcome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 years or older
- Critical attitude towards psychotherapy (self-selection)
- ability to speak and read German
- access to the internet
Key exclusion criteria (2 listed)
- known major mental disorder, such as schizophrenia or another psychotic disorder, or drug or alcohol addiction or dementia (based on self-report)
- medication that influences cognitive processes substantially (benzodiazepine)
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 |
|---|---|---|
| video intervention (therapy expectation violation)The investigators asked experts (psychotherapist and scientists in the area of clinical psychology) about typical therapy expectation violations in therapy and searched the literature for information about typical therapy processes and outcomes. Having these information they designed a script for the experimental video. The patients in the video are played by actors aged from 28 to 58 years (two male and two female actors). Patients are representing common mental disorders (depression, anxiety disorder, alcohol addiction, depression after physical disease). The abbreviated name, age and disorder of the patients is displayed for 3 seconds in the video. The patients are giving information about the mostly positive outcome and the process of their therapy. All participants are watching a video with all patients (7 minutes). The videos (control and experimental group) have been evaluated by 12 experts (psychotherapist and scientists in the area of clinical psychology). | Behavioural | Expectation violation (positive outcome of therapy) |
| video intervention (symptoms+ expectation)Participants in the control group are watching a video with the same patients (actors) as in the experimental video. In this video patients are shown before or after the first therapy session. They are giving information about symptoms and their expectation on therapy but NOT about therapy outcome. | Behavioural | Control group (symptoms + expectation) |
Primary outcome
Milwaukee Expectation Questionnaire (MPEQ)
Time frame: changes from baseline to after watching the video (approx. 20 minutes later)
Therapy expectation measured by the Milwaukee Expectation Questionnaire (MPEQ) - 13 items, German translation, self-report, subscales: process expectation and outcome expectation, total mean from min. 0 to max.10.
3 secondary outcomes
FEP/ QAPT
Time frame: changes from baseline to after watching the video (approx. 20 minutes later)
Self-report of individual expectations towards psychotherapy; mean from min. 1 to max. 7
Time frame: changes from baseline to after watching the video (approx. 20 minutes later)
Self-report of behavioral intensions towards seeking psychotherapy (self-developed items); mean from min. 1 to max.7
Time frame: changes from baseline to after watching the video (approx. 20 minutes later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Derived from this study: PubMed 35444567Braun-Koch K, Rief W. Maintenance vs. Change of Negative Therapy Expectation: An Experimental Investigation Using Video Samples. Front Psychiatry. 2022 Apr 4;13:836227. doi: 10.3389/fpsyt.2022.836227. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing video intervention (therapy expectation violation) and video intervention (symptoms+ expectation) in people with Negative Therapy Expectation, run by Philipps University Marburg.
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 2 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: status not confirmed, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Milwaukee Expectation Questionnaire (MPEQ) (time frame: changes from baseline to after watching the video (approx. 20 minutes later)). 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 NCT03594903, which also lists 1 linked publication.
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 8 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.