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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

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date June 7, 2018
Actual Study Start Date  ICMJE May 7, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
  • 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)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
  • Change in attentional bias [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period) ]
    Measured by an emotional dot-probe task
  • 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)
  • 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
  • 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)
  • 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)
  • 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.
  • 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).
  • 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.
  • Treatment Credibility and Expectancy [ Time Frame: Pre-test, Post-test (immediately after the two week intervention period) ]
    Measured by the Credibility/Expectancy Questionnaire (CEQ)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 6, 2018)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mouse-gaze Contingent Attention Training (MCAT)
Official Title  ICMJE Innovative Attention Training to Achieve Stable Remission in Depression: A Randomized Controlled Trial Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Major Depression in Remission
Intervention  ICMJE
  • Behavioral: MCAT-only
    Mouse-gaze contingent Attention Training without prior psychoeducation
  • Behavioral: MCAT-sham
    Placebo version of Mouse-gaze contingent Attention Training without prior psychoeducation
  • Behavioral: MCAT-combo
    Mouse-gaze contingent Attention Training with prior psychoeducation
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: MCAT-only
  • 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.
    Intervention: Behavioral: MCAT-sham
  • 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.
    Intervention: Behavioral: MCAT-combo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2018)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elien Pieters +32494294756 elien.pieters@ugent.be
Contact: Ernst Koster +3292646446 ernst.koster@ugent.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548519
Other Study ID Numbers  ICMJE EC/2018/0509
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Ghent
Study Sponsor  ICMJE University Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ernst Koster University Ghent
PRS Account University Ghent
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP