NCT04367636

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

April 20, 2020

Last Update Submit

November 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    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.

    pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)

  • Changes in emotional attention

    pre-test (before starting the training), post-test (immediately after the training)

Other Outcomes (7)

  • How variables related to COVID-19 and the quarantine affect the life of participants

    pre-test (before starting the training)

  • Changes in depressive complaints

    pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)

  • Changes in symptoms of anxiety

    pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)

  • +4 more other outcomes

Study Arms (2)

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.

Behavioral: Behavioral: OCAT-shamOther: 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.

Behavioral: Behavioral: OCATOther: psycho-education video

Interventions

Placebo version of the online contingent attention training preceded by psycho-education movieclip.

Active Comparator: PSE + OCAT-sham

Online contingent attention training preceded by psycho-education movieclip.

Experimental: PSE + OCAT

Both groups get to see a psycho-education video before the smartphone training starts.

Active Comparator: PSE + OCAT-shamExperimental: PSE + OCAT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Android smartphone

You may not qualify if:

  • severe depressive complaints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Rumination SyndromeAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Rudi De Raedt, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Ernst Koster, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 29, 2020

Study Start

September 30, 2020

Primary Completion

April 20, 2021

Study Completion

April 20, 2021

Last Updated

November 28, 2022

Record last verified: 2022-11

Locations