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Mouse-gaze Contingent Attention Training (MCAT)

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ClinicalTrials.gov Identifier: NCT03548519
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
University Ghent

Brief Summary:
This study evaluates the effectiveness of a computer-delivered attention control training as a preventive intervention for remitted depressed patients. Additionally, the investigators aim to increase the effect of this CBM-intervention by adding a psychoeducation module (CBT-intervention). To test this aim, participants will be randomly assigned to one of three conditions: (1) an experimental training condition with prior psychoeducation, (2) an experimental training condition without prior psychoeducation, or (3) a placebo training condition serving as an active control condition.

Condition or disease Intervention/treatment Phase
Major Depression in Remission Behavioral: MCAT-only Behavioral: MCAT-sham Behavioral: MCAT-combo Not Applicable

Detailed Description:

According to different theories and empirical research, attention control for external information and cognitive control for internal information play a causal role in cognitive emotion regulation ability, a critically important factor in determining resilience. Recent studies regarding the more specific interplay among these mechanisms in depression highlight the importance of considering attention control in treating impaired emotion regulation processes. These studies tested an interactive attention control training, in which people learned to disentangle scrambled sentences ("life is my party a mess") in a positive way ("my life is a party") by receiving eye tracking-based feedback on attention for positive ("party") vs. negative information ("mess"). Results indicated that participants were better able to reinterpret negative pictures in a positive way. Moreover, reactive attentional and cognitive control (i.e., when actually being confronted with a challenging task or stressor) seem to be influenced by perceived control or expectancy regarding the ability to cope with future stressors (i.e., in anticipation of a challenging task or stressor). More specifically, low perceived control and negative expectation bias with respect to future emotion regulation ability have been shown to result in an increased need for actual control and decreased emotion regulation abilities when actually being confronted with stressors. Based on these findings, it could be assumed that the effects of attention control training - targeting actual controlled emotion regulation processes - may be improved by adding techniques that influence perceived control/expectancy of emotion regulation ability (e.g., psychoeducation).

In the current study, the investigators aim to investigate whether a mouse-gaze based variant of the eye-gaze contingent attention training could be a promising intervention for relapse prevention in people vulnerable to depression. More specifically, the main aim is to explore whether a computer-delivered attention control training can improve depressive symptoms and cognitive emotion regulation ability (e.g., reappraisal ability), thereby increasing resilience in the face of stress, in a RMD (remitted depressed) sample. In addition, it will be explored whether prior psychoeducation may increase this effect.

In each condition, a computer training, consisting of 10 sessions of about 12 minutes each, will be administered to remitted depressed participants. The experimental condition will receive an attention training with mouse-gaze contingent feedback (i.e., mouse-gaze contingent attention training, MCAT), comprising an undirected interpretation task (instruction to unscramble as quickly as possible) as a baseline phase, followed by a positively directed interpretation task (instruction to unscramble always positive self-statements) as a modification phase (MCAT-only condition). The active placebo training will only receive the undirected interpretation task (modification phase identical to baseline phase) without mouse-gaze contingent feedback (MCAT-sham condition). Furthermore, an additional condition will combine the experimental training with a new psychoeducation session (MCAT-combo condition). This psychoeducation will focus on the role of attention processes in generating emotions. As the training tasks, this PSE-session will be self-administered and delivered in a computer-based format, including interactive graphics and video-recordings.

Before (pre-test) and after the intervention (post-test), selective attention bias and emotion regulation will be measured to investigate transfer effects of training. Also, depressive symptomatology and related variables will be assessed at pre- and post-test, as well as at follow-up, 3 and 6 months after the training.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Innovative Attention Training to Achieve Stable Remission in Depression: A Randomized Controlled Trial Study
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Attention Training
MCAT-only: An attention training, consisting of 10 sessions of ±12 minutes each (during an intervention period of two weeks), will be administered. The training task is a positively directed Scrambled Sentences Test (SST) with mouse-gaze contingent feedback.
Behavioral: MCAT-only
Mouse-gaze contingent Attention Training without prior psychoeducation

Active Comparator: Active placebo training
MCAT-sham: An active placebo training, consisting of 10 sessions of ±12 minutes each (during an intervention period of two weeks), will be administered. The training task is an undirected Scrambled Sentences Test (SST) with mouse-gaze contingent feedback.
Behavioral: MCAT-sham
Placebo version of Mouse-gaze contingent Attention Training without prior psychoeducation

Experimental: PSE and Attention Training
MCAT-combo: An online PSE session prior to an attention training, consisting of 10 sessions of ±12 minutes each (during an intervention period of two weeks), will be administered. Content of the PSE will focus on how adaptive functions of automatic and controlled processes may become maladaptive when used inappropriately or excessively. The training task is a positively directed Scrambled Sentences Test (SST) with mouse-gaze contingent feedback.
Behavioral: MCAT-combo
Mouse-gaze contingent Attention Training with prior psychoeducation




Primary Outcome Measures :
  1. Change in depression, anxiety, and stress [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months) ]
    Measured by the 21-item version of the Depression, Anxiety, and Stress Scales (DASS-21)

  2. Change in rumination [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months) ]
    Measured by the Ruminative Response Scale (RRS). This 22-item questionnaire provides a total rumination score (range: 22 - 88), as well as Brooding and Reflection subscale scores (range: 5 - 20). Brooding is characterized by a passive style of moody pondering and is the most maladaptive form of depressive rumination. Higher scores indicate a worse outcome.


Secondary Outcome Measures :
  1. Change in attentional bias [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period) ]
    Measured by an emotional dot-probe task

  2. Change in reappraisal [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period) ]
    Measured by the emotion regulation task: Average of two blind raters' scores of participants' reappraisal descriptions on a 5-point scale (0-No Description, 1-Not at all, 2-A little, 3-Good, 4-Very good) on participants' ability to reinterpret negative scenes (separately for the pre- and post-test emotion regulation tasks)

  3. Change in negative emotions (after reappraisal) [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period) ]
    Measured by the emotion regulation task: Average of negative mood ratings after using reappraisal

  4. Change in (mal-)adaptive cognitive emotion regulation strategies [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months) ]
    Measured by the Cognitive Emotion Regulation Questionnaire (CERQ)

  5. Change in maladaptive cognitive emotion regulation strategies: State rumination [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months) ]
    Measured by the Brief State Rumination Inventory (BSRI)

  6. Change in general functioning: Quality of life [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months) ]
    Measured by the depression-specific 34-item (range: 0 - 34) Quality of Life in Depression Scale (QLDS). The QLDS consists of dichotomous response questions, with the response being either True/Not True or Yes/No. It is scored binomially (0-1) and high scores on the QLDS indicate a lower quality of life.

  7. Change in general functioning: Remission from depression [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months) ]
    Measured by the 41-item Remission of Depression Questionnaire (RDQ) for which a high score is indicative for more psychopathology (range: 0 - 82).

  8. Change in general functioning: Resilience [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months) ]
    Measured by the Connor-Davidson Resilience Scale (CD-RISC). The CD-RISC comprises of 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience.

  9. Treatment Credibility and Expectancy [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period) ]
    Measured by the Credibility/Expectancy Questionnaire (CEQ)

  10. Change in motivation-related variables [ Time Frame: Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months) ]
    Measured by the Intrinsic Motivation Inventory (IMI). Subscales: Interest/Enjoyment, Perceived Competence, Effort/Importance, Pressure/Tension, Value/Usefulness


Other Outcome Measures:
  1. User engagement [ Time Frame: Post-test (immediately after the two week intervention period) ]
    Measured by the 31-item User Engagement Scale (UES). The UES comprises 6 subscales of engagement: Focused attention (FA; 7 items); Perceived usability (PU; 8 items), Aesthetic appeal (AE; 5 items), Endurability (EN; 5 items), Novelty (NO; 3 items), and Felt involvement (FI; 3 items). Scale scores are calculated for each participant by summing scores for the items in each of the six subscales and dividing by the number of items. To calculate an overall engagement score, the average of each of the six subscales of the UES long form should be summed. Higher scores indicate higher engagement.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of ≥ 1 depressive episodes (major or bipolar)
  • Currently in stable full or partial remission (≥ 3 months)
  • Being in possession of a recent computer (needed to install the training software)

Exclusion Criteria:

  • Major depressive disorder (current or less than 3 months in remission)
  • Bipolar disorder (current or less than 3 months in remission)
  • Psychotic disorder (current and/or previous)
  • Neurological impairments (current and/or previous)
  • Excessive substance abuse (current and/or previous)
  • Ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency of less than once every three weeks)
  • Use of antidepressant medication is allowed if kept at a constant level
  • Not being in possession of a recent computer (needed to install the training software)

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): NCT03548519


Contacts
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Contact: Elien Pieters +32494294756 elien.pieters@ugent.be
Contact: Ernst Koster +3292646446 ernst.koster@ugent.be

Locations
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Belgium
Ghent University Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Elien K Pieters    +32494294756    elien.pieters@ugent.be   
Contact: Ernst HW Koster         
Sub-Investigator: Elien Pieters, PhD         
Principal Investigator: Ernst HW Koster, PhD         
Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Ernst Koster University Ghent

Publications:
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03548519     History of Changes
Other Study ID Numbers: EC/2018/0509
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders