Computer-based Treatment of Dysfunctional Beliefs in Depressive Inpatients
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
computer-based confrontation with dysfunctional beliefs
Sponsored by

About this trial
This is an interventional treatment trial for Depression
Eligibility 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
Sites / Locations
- medbo Bezirksklinikum RegensburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
confrontation group
control group
Arm Description
computer-based confrontation with dysfunctional beliefs
no computer-based confrontation with dysfunctional beliefs
Outcomes
Primary Outcome Measures
change in the score on the Dysfunctional Attitude Scale
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
change in the conviction ratings for the dysfunctional beliefs
Participants will be asked to rate (on a scale ranging from 0% to 100%) how much they belief in their dysfunctional beliefs
change in the conviction ratings for the alternative beliefs
Participants will be asked to rate (on a scale ranging from 0% to 100%) how much they belief in their alternative beliefs
change in the score on the Beck Depression Inventory-II
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
Full Information
NCT ID
NCT03389464
First Posted
December 14, 2017
Last Updated
May 1, 2018
Sponsor
University of Regensburg
Collaborators
Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg, Germany
1. Study Identification
Unique Protocol Identification Number
NCT03389464
Brief Title
Computer-based Treatment of Dysfunctional Beliefs in Depressive Inpatients
Official Title
Computer-based Treatment of Dysfunctional Beliefs in Depressive Inpatients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
September 27, 2018 (Anticipated)
Study Completion Date
September 27, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg
Collaborators
Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg, Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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").
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
confrontation group
Arm Type
Experimental
Arm Description
computer-based confrontation with dysfunctional beliefs
Arm Title
control group
Arm Type
No Intervention
Arm Description
no computer-based confrontation with dysfunctional beliefs
Intervention Type
Behavioral
Intervention Name(s)
computer-based confrontation with dysfunctional beliefs
Intervention Description
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").
Primary Outcome Measure Information:
Title
change in the score on the Dysfunctional Attitude Scale
Description
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
Time Frame
at baseline, one day after the end of the intervention, at follow-up (2 weeks after the end of the intervention)
Secondary Outcome Measure Information:
Title
change in the conviction ratings for the dysfunctional beliefs
Description
Participants will be asked to rate (on a scale ranging from 0% to 100%) how much they belief in their 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)
Title
change in the conviction ratings for the alternative beliefs
Description
Participants will be asked to rate (on a scale ranging from 0% to 100%) how much they belief in their 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)
Title
change in the score on the Beck Depression Inventory-II
Description
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
Time Frame
at baseline, one day after the end of the intervention, at follow-up (2 weeks after the end of the intervention)
Other Pre-specified Outcome Measures:
Title
change in the conviction ratings for the dysfunctional beliefs (exerimental participants only)
Description
Experimental participants will be asked to rate (on a scale ranging from 0% to 100%) how much they belief in their dysfunctional beliefs
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)
Title
change in the conviction ratings for the alternative beliefs (exerimental participants only)
Description
Experimental participants will be asked to rate (on a scale ranging from 0% to 100%) how much they belief in their alternative beliefs
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)
Title
change in the difficulty ratings (experimental participants only)
Description
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
Time Frame
on the first day of the intervention, on the second day of the intervention, on the third day of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youssef Shiban, Prof.
Phone
+4955154700445
Email
shiban@pfh.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youssef Shiban, Prof.
Organizational Affiliation
PFH - Private University of Applied Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
medbo Bezirksklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rainer Rupprecht, Prof.
12. IPD Sharing Statement
Citations:
Citation
Beck AT, Steer RA, Brown GK. Beck Depression Inventory - Second Edition. Manual. San Antonio, TX: The Psychological Corporation, 1996.
Results Reference
background
Citation
Hautzinger M, Keller F, Kühner C. BDI-II - Beck Depressions-Inventar - Manual. Frankfurt: Harcourt Test Services, 2006.
Results Reference
background
Citation
Hautzinger M, Joormann J, Keller F. DAS - Skala dysfunktionaler Einstellungen - Manual. Göttingen: Hogrefe, 2005.
Results Reference
background
Citation
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.
Results Reference
background
Learn more about this trial
Computer-based Treatment of Dysfunctional Beliefs in Depressive Inpatients
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