Clinical trial NCT05269433: The Effect of Attention Training on Symptoms and Emotion Regulation in Depressive Patients
Official title: The Effect of Attention Training on Symptoms and Emotion Regulation in Depressive Patients: Validation of the Online Contingent Attention Training (OCAT).
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Keywords: Emotion Regulation
Attention Training
Psycho-education
Depression
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Alexianen Zorggroep Tienen
name: Universidad Complutense de Madrid
First posted: 2022-03-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in depression symptoms
timeFrame: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
measure: Changes in anxiety symptoms
timeFrame: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
measure: Changes in stress symptoms
timeFrame: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
Secondary outcomes:
measure: Changes in cognitive emotion regulation strategies
timeFrame: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
measure: Self-Esteem
timeFrame: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
measure: Treatment Credibility and Expectancy
timeFrame: pre-test (before starting the training), post-test (immediately after the training)
measure: Changes in emotional attention
timeFrame: pre-test (before starting the training), post-test (immediately after the training)
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
city: Tienen
country: Belgium
facility: Alexianen PK Zorggroep Tienen
state: Vlaams-Brabant
city: Sint-Denijs-Westrem
country: Belgium
facility: KARUS
Study officials:
affiliation: University Ghent
name: Rudi De Raedt, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.