- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04367636
The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 (OCAT)
The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19: Validation of a New Online Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Oost-Vlaanderen
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Gent, Oost-Vlaanderen, Belgium, 9000
- Ghent University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Android smartphone
Exclusion Criteria:
- severe depressive complaints
Study Plan
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.
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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.
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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.
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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)
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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.
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pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
|
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Changes in emotional attention
Time Frame: pre-test (before starting the training), post-test (immediately after the training)
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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)
|
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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)
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Measured by Center for Epidemiological Studies - Depression (CES-D), which has 20 items.
A higher score represents more depressive feelings (range: 0 - 60).
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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)
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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)
|
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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)
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Measured by a Visual Analogue Stress Scale, is scored from 1 (not at all) - 10 (a lot).
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pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
|
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Treatment Credibility and Expectancy
Time Frame: post-test (immediately after the training)
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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)
|
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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".
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post-test (immediately after the training)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rudi De Raedt, PhD, University Ghent
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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