Computer-based Treatment of Dysfunctional Beliefs in Depressive Inpatients

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").

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Behavioral: computer-based confrontation with dysfunctional beliefs

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youssef Shiban, Prof.; Phone Number: +4955154700445; Email: shiban@pfh.de

Study Locations

• Germany
  • Regensburg, Germany, 93053
    • Recruiting
    • medbo Bezirksklinikum Regensburg
    • Contact: Rainer Rupprecht, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at baseline, one day after the end of the intervention, at follow-up (2 weeks after the end of the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at baseline, one day after the end of the intervention, at follow-up (2 weeks after the end of the intervention)
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	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 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	at baseline, one day after the end of the intervention, at follow-up (2 weeks after the end of the intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the conviction ratings for the dysfunctional beliefs (exerimental participants only)	Experimental participants will be asked to rate (on a scale ranging from 0% to 100%) how much they belief in their dysfunctional beliefs	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)
change in the conviction ratings for the alternative beliefs (exerimental participants only)	Experimental participants will be asked to rate (on a scale ranging from 0% to 100%) how much they belief in their alternative beliefs	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)
change in the difficulty ratings (experimental participants only)	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	on the first day of the intervention, on the second day of the intervention, on the third day of the intervention

Collaborators and Investigators

• Sponsor: University of Regensburg
• Collaborators: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Anticipated): September 27, 2018
• Study Completion (Anticipated): September 27, 2018

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: FACE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No