Online Intervention to Modify Interpretation Biases in Depression

Study Overview
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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.

Official Title
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Brief Online Intervention to Modify Interpretation Biases in Depression: An Experimental Approach

Conditions
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Depression, Cognitive Change

Intervention / Treatment
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* Behavioral: Interpretation bias modification program
* Behavioral: Waiting list


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* Brief online program aimed at the modification of negative interpretation biases.<br>* Other names: Online interpretation bias intervention;|
| Other: Waiting list group<br>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<br>* Waiting list procedure for the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of the number of negative unscrambled sentences by the number of emotional unscrambled sentences in the Scrambled Sentence Test (SST) with cognitive load. | The task presents 20 scrambled sentences with 6 words each. Participants are asked to construct a sentence using 5 of the 6 words. In addition, participants are shown a number, at the beginning of the task, to report it at the end (cognitive load). The resulting ratio of correctly negative unscrambled sentences between correctly emotional unscrambled sentences is an index of automatic interpretation bias. | 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. | During the SST, words are covered so that participants can only see them when placing the mouse cursor over them. The time spent on negative words is a measure of negative attention bias. | 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. | Participants are asked to remember, during 5 minutes, the sentences they construct during the SST. The ratio of negative and emotional unscrambled sentences that participants recall is a measure of memory bias. | 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. | The task presents two jars with beads containing positive or negative adjectives. Each jar has a different ratio of positive and negative words. Participants are told that one of the jars is going to be selected and one bead is going to be taken out and returned to it in each trial. Participants have to decide which jar is being used based on the number of positive and negative adjectives that are taken in each trial. The number of beads viewed before reaching a decision is an index of jumping to conclusion bias. | 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) | Scale of 40 sentences which participants have to rate from 1 (totally agree) to 7 (totally disagree). The sum of the scores given to each sentence is an index of dysfunctional cognitive schemas. | 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 Brooding subscale of the Ruminative Responses Scale (RRS) | Subscale of 5 items which participants have to rate from 1 (totally disagree) to 5 (totally agree). The total score, ranging from 5 to 25, is an index of brooding. | Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Biases, Cognitive Bias Modification, Depression, Online intervention, Cognitive Bias Interpretation