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Maintenance (vs. Change) of Critical Attitudes Towards Psychotherapy

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ClinicalTrials.gov Identifier: NCT03594903
Recruitment Status : Not yet recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Negative Therapy Expectation Behavioral: video intervention (therapy expectation violation) Behavioral: video intervention (symptoms+ expectation) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: participants are assigned to one of two groups in parallel for the duration of the study
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Maintenance (vs. Change) of Critical Attitudes Towards Psychotherapy
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
Experimental: Expectation violation (positive outcome of therapy)
Experimental: patients` report about therapy outcome Video with patients giving information about (mostly) positive therapy outcome
Behavioral: 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).

Control group (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.

Behavioral: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. FEP/ QAPT [ Time Frame: changes from baseline to after watching the video (approx. 20 minutes later) ]
    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

  2. 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) ]
  3. 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) ]

Other Outcome Measures:
  1. Brief symptom inventory (BSI-18); total score from min.0 to max. 72 [ Time Frame: Baseline ]
    moderator

  2. Self-report measure of own experiences with psychotherapy, reports of experiences with psychotherapy of relevant others and perceived cultural reputation of psychotherapy; single scores from min 1. to max. 5. [ Time Frame: Baseline ]
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  3. Self-report of possible immunization strategies while or after watching the video (data- and concept-orientated); mean from min. 1 to max. 5 [ Time Frame: After watching the video (approx. 20 minutes after baseline) ]
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  4. Self-report of perceived sympathy, attractiveness, friendliness and identification with the patients in the video; single scores from min. 1 to max. 5 [ Time Frame: After watching the video (approx. 20 minutes after baseline) ]
    moderator



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 years or older
  • Critical attitude towards psychotherapy (self-selection)
  • ability to speak and read German
  • access to the internet

Exclusion Criteria:

  • 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)

Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03594903     History of Changes
Other Study ID Numbers: 2018-19k
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Philipps University Marburg Medical Center:
therapy expectation
therapy motivation
critical attitudes towards psychotherapy
expectation violation
Violex model
psychological online-experiment