Online Contingent Attention Training (OCAT)

Major Depression in Remission Clinical Trial

Official title:

Innovative Attention Training to Achieve Stable Remission in Depression: A Randomized Controlled Trial Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03548519
• Other study ID #: EC/2018/0509
• Status: Withdrawn
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2022
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effectiveness of a smartphone-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.

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 an online 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 an online-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 smartphone 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 gaze contingent feedback (OCAT), 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 (OCAT-only condition). The active placebo training will only receive the undirected interpretation task (modification phase identical to baseline phase) without mouse-gaze contingent feedback (OCAT-sham condition). Furthermore, an additional condition will combine the experimental training with a new psychoeducation session (OCAT-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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Major Depression in Remission

Intervention

Behavioral:
• OCAT-only
online-contingent Attention Training without prior psychoeducation
• OCAT-sham
Placebo version of Online contingent Attention Training without prior psychoeducation
• OCAT-combo
Online contingent Attention Training with prior psychoeducation

Locations

Country	Name	City	State
Belgium	Ghent University	Gent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

Sanchez A, Everaert J, Koster EH. Attention training through gaze-contingent feedback: Effects on reappraisal and negative emotions. Emotion. 2016 Oct;16(7):1074-85. doi: 10.1037/emo0000198. Epub 2016 Jun 20. — View Citation

Vanderhasselt MA, De Raedt R, De Paepe A, Aarts K, Otte G, Van Dorpe J, Pourtois G. Abnormal proactive and reactive cognitive control during conflict processing in major depression. J Abnorm Psychol. 2014 Feb;123(1):68-80. doi: 10.1037/a0035816. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User engagement	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.	Post-test (immediately after the two week intervention period)
Primary	Change in depression, anxiety, and stress	Measured by the 21-item version of the Depression, Anxiety, and Stress Scales (DASS-21)	Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Primary	Change in rumination	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.	Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Secondary	Change in attentional bias	Measured by an emotional dot-probe task	Pre-test, Post-test (immediately after the two week intervention period)
Secondary	Change in reappraisal	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)	Pre-test, Post-test (immediately after the two week intervention period)
Secondary	Change in negative emotions (after reappraisal)	Measured by the emotion regulation task: Average of negative mood ratings after using reappraisal	Pre-test, Post-test (immediately after the two week intervention period)
Secondary	Change in (mal-)adaptive cognitive emotion regulation strategies	Measured by the Cognitive Emotion Regulation Questionnaire (CERQ)	Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Secondary	Change in maladaptive cognitive emotion regulation strategies: State rumination	Measured by the Brief State Rumination Inventory (BSRI)	Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Secondary	Change in general functioning: Quality of life	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.	Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Secondary	Change in general functioning: Remission from depression	Measured by the 41-item Remission of Depression Questionnaire (RDQ) for which a high score is indicative for more psychopathology (range: 0 - 82).	Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Secondary	Change in general functioning: Resilience	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.	Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Secondary	Treatment Credibility and Expectancy	Measured by the Credibility/Expectancy Questionnaire (CEQ)	Pre-test, Post-test (immediately after the two week intervention period)
Secondary	Change in motivation-related variables	Measured by the Intrinsic Motivation Inventory (IMI). Subscales: Interest/Enjoyment, Perceived Competence, Effort/Importance, Pressure/Tension, Value/Usefulness	Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)