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Online Intervention to Modify Interpretation Biases in Depression

U

Universidad Complutense de Madrid

Status

Completed

Conditions

Cognitive Change
Depression

Treatments

Behavioral: Waiting list
Behavioral: Interpretation bias modification program

Study type

Interventional

Funder types

Other

Identifiers

NCT03987477
CT17/17-CT18/17 UCM

Details and patient eligibility

About

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.

Full description

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.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

121 participants in 2 patient groups

Experimental group
Experimental group
Description:
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.
Treatment:
Behavioral: Interpretation bias modification program
Waiting list group
Other group
Description:
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.
Treatment:
Behavioral: Waiting list

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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