Online Intervention to Modify Interpretation Biases in Depression

NCT ID: NCT03987477

Last Updated: 2022-05-02

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

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2021-03-01

Brief Summary

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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.

Detailed Description

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More specifically, the intervention is framed within the area of CBM but it is rooted on techniques and change procedures used in cognitive-behavioral therapies. While original CBM studies train participants to change cognitive biases in an automatic manner, by forcing individuals to find positive outcomes to ambiguous scenarios, this new intervention focuses on teaching participants the meaning of emotional cognitive biases and how to modify them by using an effortful type of processing (i.e., looking for adaptive alternative interpretations to ambiguous stories).

The study has been design to overcome some of the limitations that have been pointed out in this emerging research area. Firstly, although there are recent efforts to understand how interpretation, attention and memory cognitive biases may be related, it is still not clear how they interact with each other. For this purpose, some authors have pointed out the need to use longitudinal data to see how one process may affect each other over time. Secondly, different systematic reviews and meta-analyses have investigated the moderating role of variables that may be affecting the heterogeneity of results found in CBM interventions. Mental imagery has been found to be a useful tool to help participants in their changing process, while there is no preferred number of sessions for these interventions. This study will help shed some light into this factors by using mental imagery during four sessions online.

Conditions

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Depression Cognitive Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

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.

Group Type EXPERIMENTAL

Interpretation bias modification program

Intervention Type BEHAVIORAL

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

Waiting list group

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.

Group Type OTHER

Waiting list

Intervention Type BEHAVIORAL

Waiting list procedure for the control group.

Interventions

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Interpretation bias modification program

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

Intervention Type BEHAVIORAL

Waiting list

Waiting list procedure for the control group.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive bias modification Online cognitive bias intervention Online interpretation bias intervention

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmelo Vázquez, PhD

Role: STUDY_DIRECTOR

Universidad Complutense de Madrid

Locations

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Faculty of Psychology, Complutense University of Madrid

Madrid, , Spain

Site Status

Countries

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Spain

References

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 22681914 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20192795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28759865 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 24512247 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 24968234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25561486 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34358756 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34332616 (View on PubMed)

Other Identifiers

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CT17/17-CT18/17 UCM

Identifier Type: -

Identifier Source: org_study_id

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