Major Depression in RemissionNCT03548519
Online Contingent Attention Training (OCAT)
A study testing OCAT-only and OCAT-combo in people with Major Depression in Remission, run by University Ghent at 1 site in Belgium.
Trial summary
This study evaluates the effectiveness of a smartphone-delivered attention control training as a preventive intervention for remitted depressed patients. Additionally, the investigators aim to increase the effect of this CBM-intervention by adding a psychoeducation module (CBT-intervention). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression in Remission
- What is being tested?
- OCAT-only and OCAT-combo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 7 May 2018to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of ≥ 1 depressive episodes (major or bipolar)
- Currently in stable full or partial remission (≥ 3 months)
- Being in possession of a recent computer (needed to install the training software)
Who cannot join
- Major depressive disorder (current or less than 3 months in remission)
- Bipolar disorder (current or less than 3 months in remission)
- Psychotic disorder (current and/or previous)
- Neurological impairments (current and/or previous)
- Excessive substance abuse (current and/or previous)
- Ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency of less than once every three weeks)
- Use of antidepressant medication is allowed if kept at a constant level
- Not being in possession of a recent computer (needed to install the training software)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Attention Training to Achieve Stable Remission in Depression: A Randomized Controlled Trial Study
This study evaluates the effectiveness of a smartphone-delivered attention control training as a preventive intervention for remitted depressed patients. Additionally, the investigators aim to increase the effect of this CBM-intervention by adding a psychoeducation module (CBT-intervention). To test this aim, participants will be randomly assigned to one of three conditions: (1) an experimental training condition with prior psychoeducation, (2) an experimental training condition without prior psychoeducation, or (3) a placebo training condition serving as an active control condition.
Read the detailed description
According to different theories and empirical research, attention control for external information and cognitive control for internal information play a causal role in cognitive emotion regulation ability, a critically important factor in determining resilience. Recent studies regarding the more specific interplay among these mechanisms in depression highlight the importance of considering attention control in treating impaired emotion regulation processes. These studies tested an interactive attention control training, in which people learned to disentangle scrambled sentences ("life is my party a mess") in a positive way ("my life is a party") by receiving eye tracking-based feedback on attention for positive ("party") vs. negative information ("mess"). Results indicated that participants were better able to reinterpret negative pictures in a positive way. Moreover, reactive attentional and cognitive control (i.e., when actually being confronted with a challenging task or stressor) seem to be influenced by perceived control or expectancy regarding the ability to cope with future stressors (i.e., in anticipation of a challenging task or stressor). More specifically, low perceived control and negative expectation bias with respect to future emotion regulation ability have been shown to result in an increased need for actual control and decreased emotion regulation abilities when actually being confronted with stressors. Based on these findings, it could be assumed that the effects of attention control training - targeting actual controlled emotion regulation processes - may be improved by adding techniques that influence perceived control/expectancy of emotion regulation ability (e.g., psychoeducation).
In the current study, the investigators aim to investigate whether an online based variant of the eye-gaze contingent attention training could be a promising intervention for relapse prevention in people vulnerable to depression. More specifically, the main aim is to explore whether an online-delivered attention control training can improve depressive symptoms and cognitive emotion regulation ability (e.g., reappraisal ability), thereby increasing resilience in the face of stress, in a RMD (remitted depressed) sample. In addition, it will be explored whether prior psychoeducation may increase this effect.
In each condition, a smartphone training, consisting of 10 sessions of about 12 minutes each, will be administered to remitted depressed participants. The experimental condition will receive an attention training with gaze contingent feedback (OCAT), comprising an undirected interpretation task (instruction to unscramble as quickly as possible) as a baseline phase, followed by a positively directed interpretation task (instruction to unscramble always positive self-statements) as a modification phase (OCAT-only condition). The active placebo training will only receive the undirected interpretation task (modification phase identical to baseline phase) without mouse-gaze contingent feedback (OCAT-sham condition). Furthermore, an additional condition will combine the experimental training with a new psychoeducation session (OCAT-combo condition). This psychoeducation will focus on the role of attention processes in generating emotions. As the training tasks, this PSE-session will be self-administered and delivered in a computer-based format, including interactive graphics and video-recordings.
Before (pre-test) and after the intervention (post-test), selective attention bias and emotion regulation will be measured to investigate transfer effects of training. Also, depressive symptomatology and related variables will be assessed at pre- and post-test, as well as at follow-up, 3 and 6 months after the training.
- Conditions
- Major Depression in Remission
- Being tested
- OCAT-only, OCAT-sham, OCAT-combo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCAT-onlyBehavioural
online-contingent Attention Training without prior psychoeducation
OCAT-shamBehavioural
Placebo version of Online contingent Attention Training without prior psychoeducation
OCAT-comboBehavioural
Online contingent Attention Training with prior psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| Attention Training | Experimental | OCAT-only: 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 Test (SST) with mouse-gaze contingent feedback. Receives: Behavioral: OCAT-only |
| Active placebo training | Active comparator | OCAT-sham: 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 Test (SST) with mouse-gaze contingent feedback. Receives: Behavioral: OCAT-sham |
| PSE and Attention Training | Experimental | OCAT-combo: An online PSE session prior to an attention training, consisting of 10 sessions of ±12 minutes each (during an intervention period of two weeks), will be administered. Content of the PSE will focus on how adaptive functions of automatic and controlled processes may become maladaptive when used inappropriately or excessively. The training task is a positively directed Scrambled Sentences Test (SST) with mouse-gaze contingent feedback. Receives: Behavioral: OCAT-combo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression, anxiety, and stress
Measured by the 21-item version of the Depression, Anxiety, and Stress Scales (DASS-21)
Measured: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Change in rumination
Measured by the Ruminative Response Scale (RRS). This 22-item questionnaire provides a total rumination score (range: 22 - 88), as well as Brooding and Reflection subscale scores (range: 5 - 20). Brooding is characterized by a passive style of moody pondering and is the most maladaptive form of depressive rumination. Higher scores indicate a worse outcome.
Measured: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Secondary outcomes (10)
Change in attentional bias
Measured by an emotional dot-probe task
Measured: Pre-test, Post-test (immediately after the two week intervention period)
Change in reappraisal
Measured by the emotion regulation task: Average of two blind raters' scores of participants' reappraisal descriptions on a 5-point scale (0-No Description, 1-Not at all, 2-A little, 3-Good, 4-Very good) on participants' ability to reinterpret negative scenes (separately for the pre- and post-test emotion regulation tasks)
Measured: Pre-test, Post-test (immediately after the two week intervention period)
Change in negative emotions (after reappraisal)
Measured by the emotion regulation task: Average of negative mood ratings after using reappraisal
Measured: Pre-test, Post-test (immediately after the two week intervention period)
Change in (mal-)adaptive cognitive emotion regulation strategies
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ)
Measured: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Change in maladaptive cognitive emotion regulation strategies: State rumination
Measured by the Brief State Rumination Inventory (BSRI)
Measured: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Change in general functioning: Quality of life
Measured by the depression-specific 34-item (range: 0 - 34) Quality of Life in Depression Scale (QLDS). The QLDS consists of dichotomous response questions, with the response being either True/Not True or Yes/No. It is scored binomially (0-1) and high scores on the QLDS indicate a lower quality of life.
Measured: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Change in general functioning: Remission from depression
Measured by the 41-item Remission of Depression Questionnaire (RDQ) for which a high score is indicative for more psychopathology (range: 0 - 82).
Measured: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Change in general functioning: Resilience
Measured by the Connor-Davidson Resilience Scale (CD-RISC). The CD-RISC comprises of 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience.
Measured: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Treatment Credibility and Expectancy
Measured by the Credibility/Expectancy Questionnaire (CEQ)
Measured: Pre-test, Post-test (immediately after the two week intervention period)
Change in motivation-related variables
Measured by the Intrinsic Motivation Inventory (IMI). Subscales: Interest/Enjoyment, Perceived Competence, Effort/Importance, Pressure/Tension, Value/Usefulness
Measured: Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start7 May 2018
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Why it stopped: Study stopped due to technical reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depression in RemissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ernst Koster, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548519
- Sponsor's protocol ID
- EC/2018/0509
- Status last verified
- Nov 2022
- First submitted
- 15 May 2018
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez A, Everaert J, Koster EH. Attention training through gaze-contingent feedback: Effects on reappraisal and negative emotions. Emotion. 2016 Oct;16(7):1074-85. doi: 10.1037/emo0000198. Epub 2016 Jun 20.
PubMed 27322115Vanderhasselt MA, De Raedt R, De Paepe A, Aarts K, Otte G, Van Dorpe J, Pourtois G. Abnormal proactive and reactive cognitive control during conflict processing in major depression. J Abnorm Psychol. 2014 Feb;123(1):68-80. doi: 10.1037/a0035816.
PubMed 24661161
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Attention Training to Achieve Stable Remission in Depression: A Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT03548519
- Acronym / sponsor ID
- EC/2018/0509
- Conditions
- Major Depression in Remission
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped due to technical reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of a smartphone-delivered attention control training as a preventive intervention for remitted depressed patients. Additionally, the investigators aim to increase the effect of this CBM-intervention by adding a psychoeducation module (CBT-intervention). To test this aim, participants will be randomly assigned to one of three conditions: (1) an experimental training condition with prior psychoeducation, (2) an experimental training condition without prior psychoeducation, or (3) a placebo training condition serving as an active control condition.
Detailed description
According to different theories and empirical research, attention control for external information and cognitive control for internal information play a causal role in cognitive emotion regulation ability, a critically important factor in determining resilience. Recent studies regarding the more specific interplay among these mechanisms in depression highlight the importance of considering attention control in treating impaired emotion regulation processes. These studies tested an interactive attention control training, in which people learned to disentangle scrambled sentences ("life is my party a mess") in a positive way ("my life is a party") by receiving eye tracking-based feedback on attention for positive ("party") vs. negative information ("mess"). Results indicated that participants were better able to reinterpret negative pictures in a positive way. Moreover, reactive attentional and cognitive control (i.e., when actually being confronted with a challenging task or stressor) seem to be influenced by perceived control or expectancy regarding the ability to cope with future stressors (i.e., in anticipation of a challenging task or stressor). More specifically, low perceived control and negative expectation bias with respect to future emotion regulation ability have been shown to result in an increased need for actual control and decreased emotion regulation abilities when actually being confronted with stressors. Based on these findings, it could be assumed that the effects of attention control training - targeting actual controlled emotion regulation processes - may be improved by adding techniques that influence perceived control/expectancy of emotion regulation ability (e.g., psychoeducation).
In the current study, the investigators aim to investigate whether an online based variant of the eye-gaze contingent attention training could be a promising intervention for relapse prevention in people vulnerable to depression. More specifically, the main aim is to explore whether an online-delivered attention control training can improve depressive symptoms and cognitive emotion regulation ability (e.g., reappraisal ability), thereby increasing resilience in the face of stress, in a RMD (remitted depressed) sample. In addition, it will be explored whether prior psychoeducation may increase this effect.
In each condition, a smartphone training, consisting of 10 sessions of about 12 minutes each, will be administered to remitted depressed participants. The experimental condition will receive an attention training with gaze contingent feedback (OCAT), comprising an undirected interpretation task (instruction to unscramble as quickly as possible) as a baseline phase, followed by a positively directed interpretation task (instruction to unscramble always positive self-statements) as a modification phase (OCAT-only condition). The active placebo training will only receive the undirected interpretation task (modification phase identical to baseline phase) without mouse-gaze contingent feedback (OCAT-sham condition). Furthermore, an additional condition will combine the experimental training with a new psychoeducation session (OCAT-combo condition). This psychoeducation will focus on the role of attention processes in generating emotions. As the training tasks, this PSE-session will be self-administered and delivered in a computer-based format, including interactive graphics and video-recordings.
Before (pre-test) and after the intervention (post-test), selective attention bias and emotion regulation will be measured to investigate transfer effects of training. Also, depressive symptomatology and related variables will be assessed at pre- and post-test, as well as at follow-up, 3 and 6 months after the training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Attention Training | Experimental | Behavioral: OCAT-onlyOCAT-only: 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 Test (SST) with mouse-gaze contingent feedback. |
| Active placebo training | Active comparator | Behavioral: OCAT-shamOCAT-sham: 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 Test (SST) with mouse-gaze contingent feedback. |
| PSE and Attention Training | Experimental | Behavioral: OCAT-comboOCAT-combo: An online PSE session prior to an attention training, consisting of 10 sessions of ±12 minutes each (during an intervention period of two weeks), will be administered. Content of the PSE will focus on how adaptive functions of automatic and controlled processes may become maladaptive when used inappropriately or excessively. The training task is a positively directed Scrambled Sentences Test (SST) with mouse-gaze contingent feedback. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of ≥ 1 depressive episodes (major or bipolar)
- Currently in stable full or partial remission (≥ 3 months)
- Being in possession of a recent computer (needed to install the training software)
Key exclusion criteria (8 listed)
- Major depressive disorder (current or less than 3 months in remission)
- Bipolar disorder (current or less than 3 months in remission)
- Psychotic disorder (current and/or previous)
- Neurological impairments (current and/or previous)
- Excessive substance abuse (current and/or previous)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCAT-onlyonline-contingent Attention Training without prior psychoeducation | Behavioural | Attention Training |
| OCAT-shamPlacebo version of Online contingent Attention Training without prior psychoeducation | Behavioural | Active placebo training |
| OCAT-comboOnline contingent Attention Training with prior psychoeducation | Behavioural | PSE and Attention Training |
Primary outcome
Change in depression, anxiety, and stress
Time frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Measured by the 21-item version of the Depression, Anxiety, and Stress Scales (DASS-21)
Change in rumination
Time frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Measured by the Ruminative Response Scale (RRS). This 22-item questionnaire provides a total rumination score (range: 22 - 88), as well as Brooding and Reflection subscale scores (range: 5 - 20). Brooding is characterized by a passive style of moody pondering and is the most maladaptive form of depressive rumination. Higher scores indicate a worse outcome.
10 secondary outcomes
Change in attentional bias
Time frame: Pre-test, Post-test (immediately after the two week intervention period)
Change in reappraisal
Time frame: Pre-test, Post-test (immediately after the two week intervention period)
Change in negative emotions (after reappraisal)
Time frame: Pre-test, Post-test (immediately after the two week intervention period)
Change in (mal-)adaptive cognitive emotion regulation strategies
Time frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Change in maladaptive cognitive emotion regulation strategies: State rumination
Time frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Change in general functioning: Quality of life
Time frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Change in general functioning: Remission from depression
Time frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Change in general functioning: Resilience
Time frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Treatment Credibility and Expectancy
Time frame: Pre-test, Post-test (immediately after the two week intervention period)
Change in motivation-related variables
Time frame: Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Background: PubMed 27322115Sanchez A, Everaert J, Koster EH. Attention training through gaze-contingent feedback: Effects on reappraisal and negative emotions. Emotion. 2016 Oct;16(7):1074-85. doi: 10.1037/emo0000198. Epub 2016 Jun 20.
- Background: PubMed 24661161Vanderhasselt MA, De Raedt R, De Paepe A, Aarts K, Otte G, Van Dorpe J, Pourtois G. Abnormal proactive and reactive cognitive control during conflict processing in major depression. J Abnorm Psychol. 2014 Feb;123(1):68-80. doi: 10.1037/a0035816.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernst Koster principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCAT-only and OCAT-combo in people with Major Depression in Remission, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression, anxiety, and stress (time frame: Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03548519, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.