RuminationOCATNCT04367636
The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19
A study testing Behavioral: OCAT and psycho-education video in people with Rumination and Anxiety, run by University Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rumination, Anxiety, Stress
- What is being tested?
- Behavioral: OCAT and psycho-education video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Sep 2020to 20 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Android smartphone
Who cannot join
- severe depressive complaints
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rumination, Anxiety, Stress, Depressive Symptoms
- Being tested
- Behavioral: OCAT-sham, Behavioral: OCAT, psycho-education video
- Medical subject headings
- Rumination Syndrome, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: OCAT-shamBehavioural
Placebo version of the online contingent attention training preceded by psycho-education movieclip.
Behavioral: OCATBehavioural
Online contingent attention training preceded by psycho-education movieclip.
psycho-education videoOther
Both groups get to see a psycho-education video before the smartphone training starts.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: PSE + OCAT-sham | Active comparator | 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. Receives: Behavioral: Behavioral: OCAT-sham; Other: psycho-education video |
| Experimental: PSE + OCAT | Experimental | 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. Receives: Behavioral: Behavioral: OCAT; Other: psycho-education video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depression-, anxiety- and psychosomatic stress symptoms
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.
Measured: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Secondary outcomes (3)
Changes in rumination.
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.
Measured: 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.
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.
Measured: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)
Changes in emotional attention
Measured by a baseline measure in our OCAT app and measure of the end of the training period.
Measured: pre-test (before starting the training), post-test (immediately after the training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start30 Sep 2020
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Why it stopped: Due to technical difficulties with the online intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RuminationStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rudi De Raedt, PhD, Principal investigator, University GhentErnst Koster, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367636
- Sponsor's protocol ID
- EC/2019/0841
- Acronym
- OCAT
- Status last verified
- Nov 2022
- First submitted
- 20 Apr 2020
- Last updated
- 28 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19: Validation of a New Online Treatment
- ClinicalTrials.gov ID
- NCT04367636
- Acronym / sponsor ID
- OCAT / EC/2019/0841
- Conditions
- Rumination, Anxiety, Stress, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to technical difficulties with the online intervention
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: PSE + OCAT-sham | Active comparator | Behavioral: Behavioral: OCAT-sham, Other: psycho-education videoPsycho-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. |
| Experimental: PSE + OCAT | Experimental | Behavioral: Behavioral: OCAT, Other: psycho-education videoPsycho-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Android smartphone
Key exclusion criteria (1 listed)
- severe depressive complaints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: OCAT-shamPlacebo version of the online contingent attention training preceded by psycho-education movieclip. | Behavioural | Active Comparator: PSE + OCAT-sham |
| Behavioral: OCATOnline contingent attention training preceded by psycho-education movieclip. | Behavioural | Experimental: PSE + OCAT |
| psycho-education videoBoth groups get to see a psycho-education video before the smartphone training starts. | Other | Active Comparator: PSE + OCAT-sham, Experimental: PSE + OCAT |
Primary outcome
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.
3 secondary outcomes
Changes in rumination.
Time frame: 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)
Changes in emotional attention
Time frame: pre-test (before starting the training), post-test (immediately after the training)
Results and safety
The study was stopped early (reason given: Due to technical difficulties with the online intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudi De Raedt, PhD principal investigator
University Ghent
Ernst Koster, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: OCAT and psycho-education video in people with Rumination and Anxiety, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to technical difficulties with the online intervention). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.