Clinical trial NCT03987477: Online Intervention to Modify Interpretation Biases in Depression
Official title: Brief Online Intervention to Modify Interpretation Biases in Depression: An Experimental Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Cognitive Change
Keywords: Cognitive Biases
Cognitive Bias Modification
Depression
Online intervention
Cognitive Bias Interpretation
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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).
measure: Total score of each of the three subscales of the Depression, Anxiety and Stress Scale-21 (DASS) questionnaire.
timeFrame: 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).
measure: Total score on general, eudaimonic, hedonic, and social well-being as measured by the Pemberton Happiness Index (PHI)
timeFrame: 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:
measure: Ratio of the number of negative unscrambled sentences by the number of emotional unscrambled sentences in the Scrambled Sentence Test (SST) with cognitive load.
timeFrame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
measure: Proportion of time fixating the mouse cursor on negative over positive words to uncover them during the SST.
timeFrame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
measure: Ratio of recalled negative unscrambled sentences and recalled emotional unscrambled sentences during the SST.
timeFrame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
measure: Number of items viewed before reaching a decision in the Computerized Beads Task.
timeFrame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
measure: Total score on the Dysfunctional Attitudes Scale (DAS)
timeFrame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
measure: Total score on the Brooding subscale of the Ruminative Responses Scale (RRS)
timeFrame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
Other outcomes:
measure: Four of more depressive symptoms (including anhedonia and depressed modd) in the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Screening measure used after potential participants contact the main researcher to collaborate and before selecting participants to include in the study.
measure: Five of more depressive symptoms (including anhedonia and depressed modd) in the Diagnostic Inventory of Depression (DID).
timeFrame: Screening measure used after potential participants contact the main researcher to collaborate and before selecting participants to include in the study.
measure: Total score in each of the 5 subscales of the EVEA assessment of current mood.
timeFrame: Participants self-administer the scale right before each session at home and right after completing each session.
measure: 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).
timeFrame: The questionnaire is used 2 weeks and 3 moths after finishing the program (follow-ups).
measure: Total score on each of the two subscales (treatment expectancy and rationale credibility) of the Credibility and expectancy questionnaire (CEQ)
timeFrame: This scale is administered the day before starting the intervention.
measure: Total score on the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: The measure is administered one day after finishing the intervention.
Locations:
city: Madrid
country: Spain
facility: Faculty of Psychology, Complutense University of Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Carmelo Vázquez, PhD
role: STUDY_DIRECTOR
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