NCT03389464

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

January 8, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

December 14, 2017

Last Update Submit

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

EXPERIMENTAL

computer-based confrontation with dysfunctional beliefs

Behavioral: computer-based confrontation with dysfunctional beliefs

control group

NO INTERVENTION

no 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").

confrontation group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Related Publications (4)

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

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

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

    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.

    BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Youssef Shiban, Prof.

    PFH - Private University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Youssef Shiban, Prof.

CONTACT

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

Locations