Clinical trial NCT03548519: Online Contingent Attention Training (OCAT)
Official title: Innovative Attention Training to Achieve Stable Remission in Depression: A Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Major Depression in Remission
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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.

Eligibility 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)

Primary outcomes:
measure: Change in depression, anxiety, and stress
timeFrame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
measure: Change in rumination
timeFrame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Secondary outcomes:
measure: Change in attentional bias
timeFrame: Pre-test, Post-test (immediately after the two week intervention period)
measure: Change in reappraisal
timeFrame: Pre-test, Post-test (immediately after the two week intervention period)
measure: Change in negative emotions (after reappraisal)
timeFrame: Pre-test, Post-test (immediately after the two week intervention period)
measure: Change in (mal-)adaptive cognitive emotion regulation strategies
timeFrame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
measure: Change in maladaptive cognitive emotion regulation strategies: State rumination
timeFrame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
measure: Change in general functioning: Quality of life
timeFrame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
measure: Change in general functioning: Remission from depression
timeFrame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
measure: Change in general functioning: Resilience
timeFrame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
measure: Treatment Credibility and Expectancy
timeFrame: Pre-test, Post-test (immediately after the two week intervention period)
measure: Change in motivation-related variables
timeFrame: Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Other outcomes:
measure: User engagement
timeFrame: Post-test (immediately after the two week intervention period)
Locations:
city: Gent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Ernst Koster
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.