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

Primary Purpose

Depression

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
OCAT-sham
OCAT
Psycho-education video
Motivational video
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Emotion Regulation, Attention Training, Psycho-education, Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ghent University
  • Alexianen PK Zorggroep Tienen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

PSE + OCAT-sham

PSE + OCAT

PSE + OCAT+

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Changes in cognitive emotion regulation strategies
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ), a self-report questionnaire measuring different emotion regulation strategies, containing 36 items with a 5-point Likert response format scored from 1 ("Almost never") to 5 ("Almost always"). This questionnaire has 9 sub-scales: self-blame, other-blame, rumination, catastrophizing, putting into perspective, positive refocusing, positive reappraisal, acceptance and refocus on 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.
Self-Esteem
Measured by the Rosenberg Self Esteem Scale (RSES), a self-report questionnaire assessing global self-esteem. The questionnaire consists of 10 items with five positively worded items and five negatively worded. Four response categories are used, with items scored from 0 (Strongly Disagree) to 3 (Strongly Agree).
Treatment Credibility and Expectancy
Measured by the Credibility/Expectancy Questionnaire (CEQ). It measures participants' credibility and expectancy of the training. In the credibility scale, 4 items are rated on 9-point scales ranging from 1 (Not at all logical/useful/confident) to 9 (Very logical/effective/confident). This leads to a total score on this scale between 3 and 27. In the expectancy scale (2 items) the same 9-point scale is used, along with an 10-point scale (from 1% to 100%). Responses are standardized to get the total expectancy score. Higher scores represent higher credibility and expectancy. In this version of the CEQ, an extra item is included containing the question if the participant believes to be part of the placebo condition (to be responded with 'yes/no').
Changes in emotional attention
Measured by a baseline measure in the OCAT app. Participants perform a Scrambled Sentences Task to measure pre-post changes in emotional attention biases. Participants are instructed to unscramble the sentences as fast as possible to form the first grammatically correct and meaningful positive or negative sentence that spontaneously came to their mind, using only 5 words. Participants are asked to press a fixation cross to start the reading section of the SST. Then, 6 words are hidden into individual squares and participants move their fingers to uncover and read the corresponding word. When participants move their fingers away from one word to the position of another word, the previous word is hidden again and the next word is shown. The position and coordinates of the participants' finger on the screen allow us to monitor the exact time that participants are attending and reading each word, and thus to measure attention biases towards negative and positive words.

Full Information

First Posted
February 11, 2022
Last Updated
May 17, 2023
Sponsor
University Ghent
Collaborators
Alexianen Zorggroep Tienen, Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT05269433
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Alexianen Zorggroep Tienen, Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Emotion Regulation, Attention Training, Psycho-education, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PSE + OCAT-sham
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PSE + OCAT
Arm Type
Experimental
Arm Description
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.
Arm Title
PSE + OCAT+
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
OCAT-sham
Intervention Description
Placebo version of the online contingent attention training preceded by a psycho-education movieclip.
Intervention Type
Behavioral
Intervention Name(s)
OCAT
Intervention Description
Online contingent attention training preceded by a psycho-education movieclip.
Intervention Type
Other
Intervention Name(s)
Psycho-education video
Intervention Description
All groups watch a psycho-education video before the start of the 10-day attention training.
Intervention Type
Other
Intervention Name(s)
Motivational video
Intervention Description
Participants in the OCAT+ condition watch a short motivational video before each training session.
Primary Outcome Measure Information:
Title
Changes in depression symptoms
Description
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.
Time Frame
pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
Title
Changes in anxiety symptoms
Description
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.
Time Frame
pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
Title
Changes in stress symptoms
Description
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.
Time Frame
pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
Secondary Outcome Measure Information:
Title
Changes in cognitive emotion regulation strategies
Description
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ), a self-report questionnaire measuring different emotion regulation strategies, containing 36 items with a 5-point Likert response format scored from 1 ("Almost never") to 5 ("Almost always"). This questionnaire has 9 sub-scales: self-blame, other-blame, rumination, catastrophizing, putting into perspective, positive refocusing, positive reappraisal, acceptance and refocus on 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.
Time Frame
pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
Title
Self-Esteem
Description
Measured by the Rosenberg Self Esteem Scale (RSES), a self-report questionnaire assessing global self-esteem. The questionnaire consists of 10 items with five positively worded items and five negatively worded. Four response categories are used, with items scored from 0 (Strongly Disagree) to 3 (Strongly Agree).
Time Frame
pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
Title
Treatment Credibility and Expectancy
Description
Measured by the Credibility/Expectancy Questionnaire (CEQ). It measures participants' credibility and expectancy of the training. In the credibility scale, 4 items are rated on 9-point scales ranging from 1 (Not at all logical/useful/confident) to 9 (Very logical/effective/confident). This leads to a total score on this scale between 3 and 27. In the expectancy scale (2 items) the same 9-point scale is used, along with an 10-point scale (from 1% to 100%). Responses are standardized to get the total expectancy score. Higher scores represent higher credibility and expectancy. In this version of the CEQ, an extra item is included containing the question if the participant believes to be part of the placebo condition (to be responded with 'yes/no').
Time Frame
pre-test (before starting the training), post-test (immediately after the training)
Title
Changes in emotional attention
Description
Measured by a baseline measure in the OCAT app. Participants perform a Scrambled Sentences Task to measure pre-post changes in emotional attention biases. Participants are instructed to unscramble the sentences as fast as possible to form the first grammatically correct and meaningful positive or negative sentence that spontaneously came to their mind, using only 5 words. Participants are asked to press a fixation cross to start the reading section of the SST. Then, 6 words are hidden into individual squares and participants move their fingers to uncover and read the corresponding word. When participants move their fingers away from one word to the position of another word, the previous word is hidden again and the next word is shown. The position and coordinates of the participants' finger on the screen allow us to monitor the exact time that participants are attending and reading each word, and thus to measure attention biases towards negative and positive words.
Time Frame
pre-test (before starting the training), post-test (immediately after the training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudi De Raedt, Professor
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Alexianen PK Zorggroep Tienen
City
Tienen
State/Province
Vlaams-Brabant
ZIP/Postal Code
3300
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be available. Other documents will be available: Statistical Analysis Plan, Study Protocol (upon request to the researchers).
Citations:
PubMed Identifier
30735680
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.
Results Reference
background
PubMed Identifier
27064551
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.
Results Reference
background

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

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