Computer-based Treatment of Dysfunctional Beliefs in Depressive Inpatients
1 other identifier
interventional
60
1 country
1
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").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Jan 2018
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2017
CompletedFirst Posted
Study publicly available on registry
January 3, 2018
CompletedStudy Start
First participant enrolled
January 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2018
CompletedMay 2, 2018
May 1, 2018
9 months
December 14, 2017
May 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
change in the conviction ratings for the 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
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
at baseline, one day after the end of the intervention, at follow-up (2 weeks after the end of the intervention)
Other Outcomes (3)
change in the conviction ratings for the dysfunctional beliefs (exerimental participants only)
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)
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)
on the first day of the intervention, on the second day of the intervention, on the third day of the intervention
Study Arms (2)
confrontation group
EXPERIMENTALcomputer-based confrontation with dysfunctional beliefs
control group
NO INTERVENTIONno computer-based confrontation with dysfunctional beliefs
Interventions
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").
Eligibility Criteria
You may qualify if:
- diagnosis of a depressive disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
medbo Bezirksklinikum Regensburg
Regensburg, 93053, Germany
Related Publications (4)
Beck AT, Steer RA, Brown GK. Beck Depression Inventory - Second Edition. Manual. San Antonio, TX: The Psychological Corporation, 1996.
BACKGROUNDHautzinger M, Keller F, Kühner C. BDI-II - Beck Depressions-Inventar - Manual. Frankfurt: Harcourt Test Services, 2006.
BACKGROUNDHautzinger M, Joormann J, Keller F. DAS - Skala dysfunktionaler Einstellungen - Manual. Göttingen: Hogrefe, 2005.
BACKGROUNDWeissman 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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Youssef Shiban, Prof.
PFH - Private University of Applied Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 14, 2017
First Posted
January 3, 2018
Study Start
January 8, 2018
Primary Completion
September 27, 2018
Study Completion
September 27, 2018
Last Updated
May 2, 2018
Record last verified: 2018-05