NCT03987477

Brief Summary

Cognitive biases have been found to be possible causal and vulnerability factors for depression. There is empirical evidence on the presence of negative emotional biases in interpretation in people with depressive symptoms. A whole new area of research, called Cognitive Bias Modification (CBM), is focused on targeting negative cognitive emotional biases to investigate its impact on clinical symptoms. A recent meta-analysis has shown that this type of programs are effective in reducing cognitive biases but there is still controversy on their clinical value to reduce symptoms. The purpose of the study is to create a brief online intervention aimed to reduce negative emotional cognitive biases present in depression and to analyze its impact on clinical symptoms and well-being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

June 7, 2019

Last Update Submit

April 29, 2022

Conditions

DepressionCognitive Change

Keywords

Cognitive BiasesCognitive Bias ModificationDepressionOnline interventionCognitive Bias Interpretation

Outcome Measures

Primary Outcomes (3)

  • Total score of pleasantness ratings given to the ambiguous scenarios presented in the Ambiguous Scenarios Test for Depression-II, (AST-D-II) to measure interpretation bias.

    Participants are asked to rate how pleasant they perceive 15 ambiguous scenarios in a scale from -5 (very unpleasant) to 5 (very pleasant).

    Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention) and the follow-up assessments (2 weeks and 3 months after completing the intervention).

  • Total score of each of the three subscales of the Depression, Anxiety and Stress Scale-21 (DASS) questionnaire.

    Three subscales, with 7 items each, measuring symptoms of depression, anxiety and stress. Scores multiplied by 2 and summed up for each scale.

    Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention) and the follow-up assessments (2 weeks and 3 months after completing the intervention).

  • Total score on general, eudaimonic, hedonic, and social well-being as measured by the Pemberton Happiness Index (PHI)

    Scale of 11 items measuring emotional well-being at different levels.

    Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention) and the follow-up assessments (2 weeks and 3 months after completing the intervention).

Secondary Outcomes (6)

  • Ratio of the number of negative unscrambled sentences by the number of emotional unscrambled sentences in the Scrambled Sentence Test (SST) with cognitive load.

    Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).

  • Proportion of time fixating the mouse cursor on negative over positive words to uncover them during the SST.

    Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).

  • Ratio of recalled negative unscrambled sentences and recalled emotional unscrambled sentences during the SST.

    Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).

  • Number of items viewed before reaching a decision in the Computerized Beads Task.

    Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).

  • Total score on the Dysfunctional Attitudes Scale (DAS)

    Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).

  • +1 more secondary outcomes

Other Outcomes (6)

  • Four of more depressive symptoms (including anhedonia and depressed modd) in the Patient Health Questionnaire-9 (PHQ-9)

    Screening measure used after potential participants contact the main researcher to collaborate and before selecting participants to include in the study.

  • Five of more depressive symptoms (including anhedonia and depressed modd) in the Diagnostic Inventory of Depression (DID).

    Screening measure used after potential participants contact the main researcher to collaborate and before selecting participants to include in the study.

  • Total score in each of the 5 subscales of the EVEA assessment of current mood.

    Participants self-administer the scale right before each session at home and right after completing each session.

  • +3 more other outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will be exposed to a brief online program aimed at the modification of negative emotional cognitive biases. The program consists of an introduction and four 1-hour sessions, in video format. In each session, participants are required to complete some open questions and scales about the type of cognitive bias addressed in each session. All sessions are structured in four parts: 1) description and examples of some specific cognitive biases; 2) information about negative consequences of each bias; 3) explanation of adaptive strategies to modify cognitive biases (i.e., the four-questions approach used in standard Cognitive behavioral therapy); and 4) use of some practices to familiarize participants with the use of those strategies.

Behavioral: Interpretation bias modification program

Waiting list group

OTHER

The control group will be composed of individuals waiting for the treatment. Participants will not be exposed to the experimental program or any other between the pre-evaluation and the post-evaluation sessions. Participants in this group will have access to the potential benefits of the intervention after the post-evaluation of both groups.

Behavioral: Waiting list

Interventions

Interpretation bias modification programBEHAVIORAL

Brief online program aimed at the modification of negative interpretation biases.

Also known as: Cognitive bias modification, Online cognitive bias intervention, Online interpretation bias intervention
Experimental group
Waiting listBEHAVIORAL

Waiting list procedure for the control group.

Waiting list group

Eligibility Criteria

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

You may qualify if:

  • Present (PHQ-9) or past (DID) episode of depression.
  • Access to Internet
  • Fluent in Spanish language

You may not qualify if:

  • Being under any psychological treatment
  • Having a psychotic condition
  • Having any cognitive impairment or condition that do not allow to follow the program
  • Serious auditory or visual impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology, Complutense University of Madrid

Madrid, 28223, Spain

Location

Related Publications (11)

  • Becker, E. S., & Vrijsen, J. N. Cognitive processes in CBT. In The science of cognitive behavioral therapy (pp. 77-106). Academic Press, 2017

    BACKGROUND

  • Everaert J, Koster EH, Derakshan N. The combined cognitive bias hypothesis in depression. Clin Psychol Rev. 2012 Jul;32(5):413-24. doi: 10.1016/j.cpr.2012.04.003. Epub 2012 Apr 21.

    PMID: 22681914BACKGROUND

  • Gotlib IH, Joormann J. Cognition and depression: current status and future directions. Annu Rev Clin Psychol. 2010;6:285-312. doi: 10.1146/annurev.clinpsy.121208.131305.

    PMID: 20192795BACKGROUND

  • Jones EB, Sharpe L. Cognitive bias modification: A review of meta-analyses. J Affect Disord. 2017 Dec 1;223:175-183. doi: 10.1016/j.jad.2017.07.034. Epub 2017 Jul 18.

    PMID: 28759865BACKGROUND

  • Sanchez, A., Duque, A., Romero, N., & Vazquez, C. Disentangling the interplay among cognitive biases: Evidence of combined effects of attention, interpretation and autobiographical memory in depression. Cognitive Therapy and Research 41(6): 829-841, 2017.

    BACKGROUND

  • Everaert J, Duyck W, Koster EH. Attention, interpretation, and memory biases in subclinical depression: a proof-of-principle test of the combined cognitive biases hypothesis. Emotion. 2014 Apr;14(2):331-40. doi: 10.1037/a0035250. Epub 2014 Feb 10.

    PMID: 24512247BACKGROUND

  • Duque, A., López-Gómez, I., Blanco, I., & Vázquez, C. Modificación de Sesgos Cognitivos (MSC) en depresión: Una revisión crítica de nuevos procedimientos para el cambio de sesgos cognitivos. Terapia Psicológica 33(2): 103-116, 2015

    BACKGROUND

  • Menne-Lothmann C, Viechtbauer W, Hohn P, Kasanova Z, Haller SP, Drukker M, van Os J, Wichers M, Lau JY. How to boost positive interpretations? A meta-analysis of the effectiveness of cognitive bias modification for interpretation. PLoS One. 2014 Jun 26;9(6):e100925. doi: 10.1371/journal.pone.0100925. eCollection 2014.

    PMID: 24968234BACKGROUND

  • Cristea IA, Kok RN, Cuijpers P. Efficacy of cognitive bias modification interventions in anxiety and depression: meta-analysis. Br J Psychiatry. 2015 Jan;206(1):7-16. doi: 10.1192/bjp.bp.114.146761.

    PMID: 25561486BACKGROUND

  • Nieto I, Vazquez C. Disentangling the mediating role of modifying interpretation bias on emotional distress using a novel cognitive bias modification program. J Anxiety Disord. 2021 Oct;83:102459. doi: 10.1016/j.janxdis.2021.102459. Epub 2021 Jul 29.

    PMID: 34358756DERIVED

  • Nieto I, Vazquez C. 'Relearning how to think': A brief online intervention to modify biased interpretations in emotional disorders-study protocol for a randomised controlled trial. Trials. 2021 Jul 31;22(1):510. doi: 10.1186/s13063-021-05459-3.

    PMID: 34332616DERIVED

MeSH Terms

Conditions

Depression

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Carmelo Vázquez, PhD

    Universidad Complutense de Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 17, 2019

Study Start

September 30, 2019

Primary Completion

December 30, 2020

Study Completion

March 1, 2021

Last Updated

May 2, 2022

Record last verified: 2022-04

Locations

ES(1)