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Computer-based Treatment of Dysfunctional Beliefs in Depressive Inpatients

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ClinicalTrials.gov Identifier: NCT03389464
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg, Germany
Information provided by (Responsible Party):
Shiban Youssef, University of Regensburg

Study Description
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Brief Summary:
The aim of the present study is to investigate whether confronting depressive patients with their dysfunctional core beliefs via a computer program results in a reduction of the patients' dysfunctional beliefs. Patients will be presented with a virtual agent confronting them with their dysfunctional core beliefs (e.g. "You are worthless"). Participants will be instructed to contradict these virtual agents (e.g. "That's not true, I'm a wonderful person").

Condition or disease Intervention/treatment Phase
Depression Behavioral: computer-based confrontation with dysfunctional beliefs Not Applicable

Detailed Description:

The aim of the present study is to investigate whether confronting depressive patients with their dysfunctional core beliefs via a computer program results in a reduction of the patients' dysfunctional beliefs. Participants will randomly be assigned to the experimental or control group. In the course of the study, experimental participants will be presented with a virtual agent confronting them with their dysfunctional core beliefs (e.g. "You are worthless"). Experimental participants will be instructed to contradict these virtual agents (e.g. "That's not true, I'm a wonderful person").

A group of inpatients (male/female) suffering from depression will participate in the study. The patients will be recruited at the "Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg".

The study will be divided into five sessions taking place on consecutive days. Furthermore, there will be a follow-up.

Session 1:

In the course of this session participants will be informed about the experimental procedure and sign an informed consent. Exclusion criteria will be assessed via self-report and by consulting the responsible therapist. Participants will be asked to fill in the German version of the Beck Depression Inventory-II and German version of the Dysfunctional Attitude Scale. The experimenter will explain the concept of dysfunctional "core beliefs" to the participants and give examples. Participants will be asked to write down three individual core beliefs (e.g. "I'm worthless") and to rate how much they believe in each of these three core beliefs (on a scale ranging from 0% to 100%). Furthermore, participants will be asked to write down alternative beliefs for each of the three core beliefs and to rate (on a scale ranging from 0% to 100%) how much they believe in these alternative beliefs.

Sessions 2 to 4 (intervention):

During these sessions, the experimental participants will be seated in front of a computer. The experimenter will read aloud the participants' core beliefs with the virtual agent on the computer screen moving his lips accordingly. Thus, participants will get the impression of the agent speaking to them. Participants will be instructed to contradict the agent. There will be 10 trials per core belief (30 trials per session, 90 trials in total). At the end of each session, participants will be asked to rate how much they believe in each of their core beliefs as well as in each of their alternative beliefs. Furthermore, they will be asked to rate (on a scale ranging from 0% to 100%) how hard it was for them to contradict the virtual agent. Control subjects will not undergo sessions 2 to 4.

Session 5:

Participants will fill in the German version of the Beck Depression Inventory-II and the German version of Dysfunctional Attitude Scale and give a conviction rating for each of their three core beliefs and each of their alternative beliefs.

Follow-up (after two weeks):

Participants will fill in the German version of the Beck Depression Inventory-II and the German version of the Dysfunctional Attitude Scale and give a conviction rating for each of their three core beliefs and each of their alternative beliefs.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Computer-based Treatment of Dysfunctional Beliefs in Depressive Inpatients
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : September 27, 2018
Estimated Study Completion Date : September 27, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: confrontation group
computer-based confrontation with dysfunctional beliefs
 Behavioral: computer-based confrontation with dysfunctional beliefs
Patients will be presented with a virtual agent confronting them with their dysfunctional core beliefs (e.g. "You are worthless"). Participants will be instructed to contradict these virtual agents (e.g. "That's not true, I'm a wonderful person").
No Intervention: control group
no computer-based confrontation with dysfunctional beliefs


Outcome Measures
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Primary Outcome Measures :
  1. change in the score on the Dysfunctional Attitude Scale [ Time Frame: at baseline, one day after the end of the intervention, at follow-up (2 weeks after the end of the intervention) ]
    change in the score (ranging from 40 to 280 with higher scores indicating more dysfunctional attitudes) on the German version of the Dysfunctional Attitude Scale


Secondary Outcome Measures :
  1. change in the conviction ratings for the dysfunctional beliefs [ Time Frame: at baseline, one day after the end of the intervention, at follow-up (2 weeks after the end of the intervention) ]
    Participants will be asked to rate (on a scale ranging from 0% to 100%) how much they belief in their dysfunctional beliefs

  2. change in the conviction ratings for the alternative beliefs [ Time Frame: at baseline, one day after the end of the intervention, at follow-up (2 weeks after the end of the intervention) ]
    Participants will be asked to rate (on a scale ranging from 0% to 100%) how much they belief in their alternative beliefs

  3. change in the score on the Beck Depression Inventory-II [ Time Frame: at baseline, one day after the end of the intervention, at follow-up (2 weeks after the end of the intervention) ]
    change in the score (ranging from 0 to 63 with higher scores indicating more severe depressive symptoms) on the German version of the Beck Depression Inventory-II


Other Outcome Measures:
  1. change in the conviction ratings for the dysfunctional beliefs (exerimental participants only) [ Time Frame: at baseline, on the first day of the intervention, on the second day of the intervention, on the third day of the intervention, one day after the end of the intervention, at follow-up (2 weeks after the end of the intervention) ]
    Experimental participants will be asked to rate (on a scale ranging from 0% to 100%) how much they belief in their dysfunctional beliefs

  2. change in the conviction ratings for the alternative beliefs (exerimental participants only) [ Time Frame: at baseline, on the first day of the intervention, on the second day of the intervention, on the third day of the intervention, one day after the end of the intervention, at follow-up (2 weeks after the end of the intervention) ]
    Experimental participants will be asked to rate (on a scale ranging from 0% to 100%) how much they belief in their alternative beliefs

  3. change in the difficulty ratings (experimental participants only) [ Time Frame: on the first day of the intervention, on the second day of the intervention, on the third day of the intervention ]
    Experimental participants will be asked to rate (on a scale ranging from 0% to 100%) how hard it was for them to contradict the virtual agent


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• diagnosis of a depressive disorder

Exclusion Criteria:

  • substantial and imminent suicide risk
  • current psychotic symptoms
  • history of psychotic symptoms
  • current manic episode
  • current diagnosis of alcohol or drug abuse or dependence
  • hearing problems
  • poor eyesight
  • pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389464


Contacts
Contact: Youssef Shiban, Prof. +4955154700445 shiban@pfh.de

Locations
Germany
medbo Bezirksklinikum Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Rainer Rupprecht, Prof.         
Sponsors and Collaborators
University of Regensburg
Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg, Germany
Investigators
Principal Investigator: Youssef Shiban, Prof. PFH - Private University of Applied Sciences
More Information
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Publications:
Beck AT, Steer RA, Brown GK. Beck Depression Inventory - Second Edition. Manual. San Antonio, TX: The Psychological Corporation, 1996.
Hautzinger M, Keller F, Kühner C. BDI-II - Beck Depressions-Inventar - Manual. Frankfurt: Harcourt Test Services, 2006.
Hautzinger M, Joormann J, Keller F. DAS - Skala dysfunktionaler Einstellungen - Manual. Göttingen: Hogrefe, 2005.
Weissman AN, Beck AT. Development and validation of the Dysfunctional Attitude Scale: A preliminary investigation. Paper presented at the annual meeting of the Association for the Advancement of Behavior Therapy, Chicago, 1978.

Responsible Party: Shiban Youssef, Principal Investigator, University of Regensburg
ClinicalTrials.gov Identifier: NCT03389464     History of Changes
Other Study ID Numbers: Face
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

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