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

NCT05269433 | Enrolling By Invitation

• 1 other identifier: 0G054-2021-07
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Depression

Keywords

Emotion Regulation; Attention Training; Psycho-education; Depression

Outcome Measures

Primary Outcomes (3)

• Changes in depression symptoms

  Measured by the Depression and Anxiety Stress Scale (DASS-21), a self report questionnaire containing 21 items to measure the severity of a range of common symptoms for depression, anxiety and stress. Participants are required to indicate the presence of a symptom over the previous week. Each item of the questionnaire is scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Higher scores indicate more symptoms. The questionnaire comprises three subscales (Depression, Anxiety, and Stress). For this specific outcome measure, the depression subscale will be used (7 items) to investigate the specific effects of the training on depressive symptoms.

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

• Changes in anxiety symptoms

  Measured by the Depression and Anxiety Stress Scale (DASS-21), a self report questionnaire containing 21 items to measure the severity of a range of common symptoms for depression, anxiety and stress. Participants are required to indicate the presence of a symptom over the previous week. Each item of the questionnaire is scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Higher scores indicate more symptoms. The questionnaire comprises three subscales (Depression, Anxiety, and Stress). For this specific outcome measure, the anxiety subscale will be used (7 items) to investigate the specific effects of the training on anxiety symptoms.

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

• Changes in stress symptoms

  Measured by the Depression and Anxiety Stress Scale (DASS-21), a self report questionnaire containing 21 items to measure the severity of a range of common symptoms for depression, anxiety and stress. Participants are required to indicate the presence of a symptom over the previous week. Each item of the questionnaire is scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Higher scores indicate more symptoms. The questionnaire comprises three subscales (Depression, Anxiety, and Stress). For this specific outcome measure, the stress subscale will be used (7 items) to investigate the specific effects of the training on stress symptoms.

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

Secondary Outcomes (4)

• Changes in cognitive emotion regulation strategies

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

• Self-Esteem

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

• Treatment Credibility and Expectancy

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

• Changes in emotional attention

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

Study Arms (3)

PSE + OCAT-sham

ACTIVE COMPARATOR

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.

Behavioral: OCAT-sham; Other: Psycho-education video

PSE + OCAT

EXPERIMENTAL

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.

Behavioral: OCAT; Other: Psycho-education video

PSE + OCAT+

EXPERIMENTAL

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.

Behavioral: OCAT; Other: Psycho-education video; Other: Motivational video

Interventions

OCAT-sham BEHAVIORAL

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

PSE + OCAT-sham

OCAT BEHAVIORAL

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

PSE + OCAT; PSE + OCAT+

Psycho-education video OTHER

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

PSE + OCAT; PSE + OCAT+; PSE + OCAT-sham

Motivational video OTHER

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

PSE + OCAT+

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current psychotic disorder
• Current neurological impairments
• Current alcohol addiction
• Current treatment with antidepressants that has not yet been kept constant

Sponsors & Collaborators

• University Ghent: lead
• Alexianen Zorggroep Tienen: collaborator
• Universidad Complutense de Madrid: collaborator

Study Sites (3)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Alexianen PK Zorggroep Tienen

Tienen, Vlaams-Brabant, 3300, Belgium

Location

KARUS

Sint-Denijs-Westrem, 9051, Belgium

Location

Related Publications (2)

• 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.

  PMID: 30735680 BACKGROUND

• 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.

  PMID: 27064551 BACKGROUND

MeSH Terms

Conditions

Depression; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Officials

• Rudi De Raedt, Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 8, 2022
• Study Start: March 8, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)