The Effect of Attention Training on Symptoms and Emotion Regulation in Depressive Patients

NCT ID: NCT05269433

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-08

Study Completion Date

2025-12-31

Brief Summary

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Attention control for external information and cognitive control for internal information play a causal role in emotion regulation according to different theories and research. Prior research shows that an interactive attention control training in which participants learn to unravel scrambled sentences ("life is my a party mess") in a positive manner ("my life is a party") by receiving feedback on their eye movements while attending to the valenced words, can facilitate participants to be more able to re-interpret negative information in a positive manner. In the current study we want to test the effect of psycho-education in combination with a 10 day attention control training to see if this has a positive effect on depressive, anxiety and stress symptoms, emotion regulation and self-esteem in depressed patients. The study takes place in a psychiatric hospital (Alexianen Zorggroep Tienen) while participants are staying there to receive treatment.

Detailed Description

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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 training where 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") when looking at the sentences. After the training, participants could better reinterpret negative pictures in a positive way. Attention- and cognitive control mechanisms prior to negative stressors (proactive control) and after negative stressors (reactive control) may play a role in the effects. Research suggests 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 (i.e. psycho-education, additional short motivational video). In the present study this is investigated by testing a new 10 day attention control training to see if this has a positive effect on depressive, anxiety and stress symptoms, emotion regulation and self-esteem. Participants between 18 to 65 years of age are recruited during their admission in a psychiatric hospital (Alexianen Zorggroep Tienen). The attention control training is a new smartphone based application where participants are asked to unscramble scrambled sentences into grammatically correct sentences. Participants are randomly assigned to one of three conditions: a training condition with preceding psycho-education video (OCAT), a control condition with preceding psycho-education video (OCAT-sham), and a training condition with preceding psycho-education video and additional short motivational video before each training session (OCAT+). In the training conditions (OCAT and OCAT+), participants are asked to unscramble the scrambled sentences in a positive way. By swiping, participants can see parts 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 conditions participants receive feedback about the duration of processing positive and negative words. In the control group participants unscramble the sentences as fast as possible without feedback on emotional attention. Participants in the control condition only receive feedback about the speed by which the sentences are unscrambled. Before and after the 10 training sessions, attention of the participants is measured. Questionnaires on depressive, anxiety, and stress symptoms, emotion regulation strategies, and self-esteem are administered before and after the training. Moreover, participants' credibility and expectancy towards the training will also be measured. There is also a follow-up measure 3 months after the training. All groups (training and control) watch a psycho-education video before the start of the training.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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PSE + OCAT-sham

Psycho-education video + an active placebo training consisting of 10 sessions of ±12 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 (only) on the speed with which the sentences were made. In this condition, participants will not receive feedback on emotional attention.

Group Type ACTIVE_COMPARATOR

OCAT-sham

Intervention Type BEHAVIORAL

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

Psycho-education video

Intervention Type OTHER

All groups watch a psycho-education video before the start of the 10-day attention training.

PSE + OCAT

Psycho-education video + an attention training consisting of 10 sessions of ±12 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 on how much attention was paid to positive vs. negative words (emotional attention), along with feedback on the speed with which the sentences were made.

Group Type EXPERIMENTAL

OCAT

Intervention Type BEHAVIORAL

Online contingent attention training preceded by a psycho-education movieclip.

Psycho-education video

Intervention Type OTHER

All groups watch a psycho-education video before the start of the 10-day attention training.

PSE + OCAT+

Psycho-education video + short motivational video before each training session + an attention training consisting of 10 sessions of ±12 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 on how much attention was paid to positive vs. negative words (emotional attention), along with feedback on the speed with which the sentences were made.

Group Type EXPERIMENTAL

OCAT

Intervention Type BEHAVIORAL

Online contingent attention training preceded by a psycho-education movieclip.

Psycho-education video

Intervention Type OTHER

All groups watch a psycho-education video before the start of the 10-day attention training.

Motivational video

Intervention Type OTHER

Participants in the OCAT+ condition watch a short motivational video before each training session.

Interventions

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OCAT-sham

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

Intervention Type BEHAVIORAL

OCAT

Online contingent attention training preceded by a psycho-education movieclip.

Intervention Type BEHAVIORAL

Psycho-education video

All groups watch a psycho-education video before the start of the 10-day attention training.

Intervention Type OTHER

Motivational video

Participants in the OCAT+ condition watch a short motivational video before each training session.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of depressive disorder
* Admission to a psychiatric hospital (Alexianen PK, Tienen)

Exclusion Criteria

* Current psychotic disorder
* Current neurological impairments
* Current alcohol addiction
* Current treatment with antidepressants that has not yet been kept constant
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexianen Zorggroep Tienen

UNKNOWN

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rudi De Raedt, Professor

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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Ghent University

Ghent, Oost-Vlaanderen, Belgium

Site Status

Alexianen PK Zorggroep Tienen

Tienen, Vlaams-Brabant, Belgium

Site Status

KARUS

Sint-Denijs-Westrem, , Belgium

Site Status

Countries

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Belgium

References

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Sanchez-Lopez A, Everaert J, Van Put J, De Raedt R, Koster EHW. Eye-gaze contingent attention training (ECAT): Examining the causal role of attention regulation in reappraisal and rumination. Biol Psychol. 2019 Mar;142:116-125. doi: 10.1016/j.biopsycho.2019.01.017. Epub 2019 Feb 5.

Reference Type BACKGROUND
PMID: 30735680 (View on PubMed)

De Raedt R, Hooley JM. The role of expectancy and proactive control in stress regulation: A neurocognitive framework for regulation expectation. Clin Psychol Rev. 2016 Apr;45:45-55. doi: 10.1016/j.cpr.2016.03.005. Epub 2016 Mar 24.

Reference Type BACKGROUND
PMID: 27064551 (View on PubMed)

Other Identifiers

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0G054-2021-07

Identifier Type: -

Identifier Source: org_study_id

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