Computer-based Treatment of Dysfunctional Beliefs in Depressive Inpatients

NCT ID: NCT03389464

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2018-09-27

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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confrontation group

computer-based confrontation with dysfunctional beliefs

Group Type EXPERIMENTAL

computer-based confrontation with dysfunctional beliefs

Intervention Type BEHAVIORAL

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").

control group

no computer-based confrontation with dysfunctional beliefs

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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").

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg, Germany

UNKNOWN

Sponsor Role collaborator

University of Regensburg

OTHER

Sponsor Role lead

Responsible Party

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Shiban Youssef

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Youssef Shiban, Prof.

Role: PRINCIPAL_INVESTIGATOR

PFH - Private University of Applied Sciences

Locations

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medbo Bezirksklinikum Regensburg

Regensburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Youssef Shiban, Prof.

Role: CONTACT

+4955154700445

Facility Contacts

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Rainer Rupprecht, Prof.

Role: primary

References

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Beck AT, Steer RA, Brown GK. Beck Depression Inventory - Second Edition. Manual. San Antonio, TX: The Psychological Corporation, 1996.

Reference Type BACKGROUND

Hautzinger M, Keller F, Kühner C. BDI-II - Beck Depressions-Inventar - Manual. Frankfurt: Harcourt Test Services, 2006.

Reference Type BACKGROUND

Hautzinger M, Joormann J, Keller F. DAS - Skala dysfunktionaler Einstellungen - Manual. Göttingen: Hogrefe, 2005.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Other Identifiers

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Face

Identifier Type: -

Identifier Source: org_study_id

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