Skip to main content
OpenTrials
Completed

NCT Number: NCT03987477

Online Intervention to Modify Interpretation Biases in Depression

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms Cognitive Change

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Psychology, Complutense University of Madrid

Madrid, 28223, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interpretation bias modification program

Behavioral

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

Other names: Cognitive bias modification, Online cognitive bias intervention, Online interpretation bias intervention

Waiting list

Behavioral

Waiting list procedure for the control group.

Primary outcomes

  1. 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.

    Time frame: 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).

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

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

    Time frame: 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).

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

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

    Time frame: 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).

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

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

  5. Total score on the Dysfunctional Attitudes Scale (DAS)

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

    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.

  6. Total score on the Brooding subscale of the Ruminative Responses Scale (RRS)

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

    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.

Other outcomes

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

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

    9 items measuring symptoms of depression from 1 (not at all) to 4 (nearly everyday). Diagnosis is made if participants select 3 o 4 in four or more items (including anhedonia and depressed mood).

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

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

    Scale of 42 items measuring symptoms of depression in the past from 0 to 4.

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

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

    Participants have to rate, from 0 to 10, their current level of anger, happiness, anxiety, depression, and boredom. Scores of each subscale (4 items each) are summed up.

  4. Total number of events, total number of times, mean score on negative impact and mean duration time of the negative impact of the negative events selected in the Stressful events questionnaire (based on Life Events Scale, LES).

    Time frame: The questionnaire is used 2 weeks and 3 moths after finishing the program (follow-ups).

    A 47-item questionnaire in which participants select negative events they have experienced during the last two weeks or three months, the number of times each event was experienced, the emotional impact of the event and the duration time of the emotional impact. The different indexes represent experience of stressful events.

  5. Total score on each of the two subscales (treatment expectancy and rationale credibility) of the Credibility and expectancy questionnaire (CEQ)

    Time frame: This scale is administered the day before starting the intervention.

    6 items measuring patients' expectancy of treatment success and credibility of the treatment prior to the intervention.

  6. Total score on the Client Satisfaction Questionnaire (CSQ-8)

    Time frame: The measure is administered one day after finishing the intervention.

    8 items measuring participants' satisfaction with the treatment rated with a 4-point scale where 1 reflects 'very low satisfaction' and 4 reflects 'very high satisfaction'.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jun 17, 2019
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.