Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03548519
Other study ID # EC/2018/0509
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Completed NCT03278756 - Online Cognitive Control Training for Remitted Depressed Patients N/A
Recruiting NCT05557760 - Effects of Booster Sessions on Depression Vulnerability Following Cognitive Control Training N/A
Not yet recruiting NCT05579015 - Predicting Illness Trajectories In Fully Remitted Major Depression Using Concurrent TBS/fNIRS N/A
Recruiting NCT04325529 - Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.2 (Stress Manipulation)
Completed NCT05166798 - Optimal Dose of a Cognitive Control Training for Depression Vulnerability N/A
Completed NCT02407652 - Cognitive Control Training for Remitted Depressed Patients N/A
Recruiting NCT04944758 - Feasibility of Adherence to Light Therapy N/A
Recruiting NCT04864353 - Internet-delivered Intervention Targeting Residual Cognitive Symptoms After Major Depressive Disorder N/A