The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 (OCAT)

November 21, 2022 updated by: University Ghent

The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19: Validation of a New Online Treatment

Attention control for external information and cognitive control for internal information play a causal role in emotion regulation according to different theories and empirical research. Former research in the lab of the investigators has shown positive effects of an interactive attention control/interpretation training, in which participants learned to unscramble scrambled sentences ("life is my a party mess") in a positive way ("my life is a party") by getting eye-tracking feedback about attention for positive ("party") vs. negative information ("mess"). After the training, participants could better reinterpret negative photos in a positive way. Attention- and cognitive control mechanisms prior to negative stressors (proactive control) and after negative stressors (reactive control) seem to play a role in this. Moreover, research has shown that low perceived control and negative expectations about future emotion regulation skills results in lower proactive control and a higher need of reactive control. Based on this, the assumption can be made that the effects of attention control training - targeting reactive control - could benefit from adding techniques that affect proactive control (e.g. psycho-education). In the present study this is investigated by testing a new two weeks attention control training to see if this has a positive effect on stress related complaints, depressive symptoms and emotion regulation. Given that the current COVID-19 pandemic is perceived as very stressful by a lot of people, the training could help here. Participants between 18 to 65 years of age are recruited during this corona crisis. The attention control training is a new smartphone based application. Participants have to unscramble scrambled sentences into grammatically correct sentences. In the training condition, participants are asked to unscramble the scrambled sentences in a positive way. By swiping, participants can see part of the sentences. This gives the investigators an image about the processing of the sentences. This procedure allows to measure how long participants attend to positive and negative words. In the training condition participants get feedback about the duration they process positive and negative words. In the control group participants unscramble the sentences as fast as possible without feedback on emotional attention. Participants only get feedback about the speed at which sentences are unscrambled. Before and after the 10 training sessions, attention of the participants is measured to see the effects of the training. Questionnaires on depressive and anxiety complaints, emotion regulation strategies, well-being and stress are administered before and after the training. There is also a follow-up measure 2 months after the training. Both groups (training and control) watch a psycho-education video before the start of the training.

Study Overview

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Ghent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Android smartphone

Exclusion Criteria:

  • severe depressive complaints

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Active Comparator: PSE + OCAT-sham
Psycho-education video + an active placebo training, consisting of 10 sessions of ±15 minutes each (during an intervention period of two weeks), will be administered. The training task is an undirected scrambled sentences task with online contingent feedback.
Placebo version of the online contingent attention training preceded by psycho-education movieclip.
Both groups get to see a psycho-education video before the smartphone training starts.
EXPERIMENTAL: Experimental: PSE + OCAT
Psycho-education video + an attention training, consisting of 10 sessions of ±15 minutes each (during an intervention period of two weeks), will be administered. The training task is a positively directed scrambled sentences task with online contingent feedback.
Both groups get to see a psycho-education video before the smartphone training starts.
Online contingent attention training preceded by psycho-education movieclip.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in depression-, anxiety- and psychosomatic stress symptoms
Time Frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Measured by Mood and Anxiety Symptom Questionnaire (MASQ-30). It measures the dimensions of Clark and Watson's tripartite model, covering both shared and distinct symptoms of depression and anxiety. It has three sub-scales: Negative Affect (NA), associated with both depression and anxiety; lack of Positive Affect (PA), associated with depressive moods; and Somatic Arousal (SA), associated with anxiety. Scores are ranging from 10 to 50, with higher scores indicating more severe psychopathology.
pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in rumination.
Time Frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Measured by Rumination Response Scale (RRS). This 22-item questionnaire provides a total rumination score (range: 22 - 88), as well as Brooding and Reflection sub-scale scores (range: 5 - 20). Brooding is characterized by a passive style of moody pondering. Higher scores indicate a worse outcome.
pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Changes in cognitive emotion regulation strategies.
Time Frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ). Which measures different emotion regulation strategies. This questionnaire has 9 sub-scales: self-blame, other-blame, rumination, catastrophizing, putting into perspective, positive refocusing, positive reappraisal, acceptance and planning. Each sub-scale has a scoring range between 4 and 20. A higher score represents a greater frequency of engaging in that emotion regulation strategy.
pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Changes in emotional attention
Time Frame: pre-test (before starting the training), post-test (immediately after the training)
Measured by a baseline measure in our OCAT app and measure of the end of the training period.
pre-test (before starting the training), post-test (immediately after the training)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
How variables related to COVID-19 and the quarantine affect the life of participants
Time Frame: pre-test (before starting the training)
Measured by the COVID questionnaire (designed by the researchers).
pre-test (before starting the training)
Changes in depressive complaints
Time Frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Measured by Center for Epidemiological Studies - Depression (CES-D), which has 20 items. A higher score represents more depressive feelings (range: 0 - 60).
pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Changes in symptoms of anxiety
Time Frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Measured by the Generalized Anxiety Disorder 7 item scale (GAD-7). Scores may vary from 0 to >15. A higher score represents more symptoms of anxiety.
pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Changes in well-being
Time Frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Measured by the Warwick-Edinburgh Mental Well-being Scales (WE-MWB). This 14-item scale indexes positive aspects of mental health. Scores may vary between 14 and 70. A higher score represents a more positive mental health.
pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Changes in perceived stress
Time Frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Measured by a Visual Analogue Stress Scale, is scored from 1 (not at all) - 10 (a lot).
pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Treatment Credibility and Expectancy
Time Frame: post-test (immediately after the training)

Measured by the Credibility/Expectancy Questionnaire (CEQ). It measures participants' credibility and expectancy of the training. In the credibility scale the items are rated on 9- point scales ranging from 1 (Not at all logical/useful/confident) to 9 (Very logical/effective/confident). This leads to a total score on this scale between 3 and 27.

In the expectancy scale the same 9-point scale is used and an 11-point scale (from 0% to 100%). Responses are standardized to get the total expectancy score. Higher scores represent higher credibility and expectancy.

post-test (immediately after the training)
Perceived pleasantness of the training
Time Frame: post-test (immediately after the training)
A question was added to determine how pleasant the training is perceived by the participants. It is scored on a scale from 0 to 10 where 0 stands for "very unpleasant" and 10 stands for "very pleasant".
post-test (immediately after the training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rudi De Raedt, PhD, University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 30, 2020

Primary Completion (ACTUAL)

April 20, 2021

Study Completion (ACTUAL)

April 20, 2021

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (ACTUAL)

April 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 21, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2019/0841

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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