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Trial record 14 of 125 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Spain )

Online Intervention to Modify Interpretation Biases in Depression

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ClinicalTrials.gov Identifier: NCT03987477
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Universidad Complutense de Madrid

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.

Condition or disease Intervention/treatment Phase
Depression Cognitive Change Behavioral: Interpretation bias modification program Behavioral: Waiting list Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brief Online Intervention to Modify Interpretation Biases in Depression: An Experimental Approach
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Interpretation bias modification program
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 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.
Behavioral: Waiting list
Waiting list procedure for the control group.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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'.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987477


Contacts
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Contact: Carmelo Vázquez, PhD +34 645326292 cvazquez@psi.ucm.es
Contact: Inés Nieto, MSc +34 646204266 inenieto@ucm.es

Locations
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Spain
Faculty of Psychology, Complutense University of Madrid Not yet recruiting
Madrid, Spain, 28223
Contact: Carmelo Vazquez    +34 645326292    cvazquez@psi.ucm.es   
Contact: Ines Nieto    +34 646204266    inenieto@ucm.es   
Sponsors and Collaborators
Universidad Complutense de Madrid
Investigators
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Study Director: Carmelo Vázquez, PhD Universidad Complutense de Madrid

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

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Responsible Party: Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT03987477     History of Changes
Other Study ID Numbers: CT17/17-CT18/17 UCM
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The authors have not decided yet on IPD sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad Complutense de Madrid:
Cognitive Biases
Cognitive Bias Modification
Depression
Online intervention
Cognitive Bias Interpretation
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders