DepressionNCT05269433
The Effect of Attention Training on Symptoms and Emotion Regulation in Depressive Patients
A study testing OCAT, Psycho-education video and Motivational video in people with Depression, run by University Ghent at 3 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- OCAT, Psycho-education video and Motivational video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesBelgium
- Study dates
- 8 Mar 2022to 31 Dec 2025
- 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
- Diagnosis of depressive disorder
- Admission to a psychiatric hospital (Alexianen PK, Tienen)
Who cannot join
- Current psychotic disorder
- Current neurological impairments
- Current alcohol addiction
- Current treatment with antidepressants that has not yet been kept constant
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Ghent University
Ghent, Oost-Vlaanderen, 9000
KARUS
Sint-Denijs-Westrem, 9051
Alexianen PK Zorggroep Tienen
Tienen, Vlaams-Brabant, 3300
About this study
Official title: The Effect of Attention Training on Symptoms and Emotion Regulation in Depressive Patients: Validation of the Online Contingent Attention Training (OCAT).
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.
Read the 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.
- Conditions
- Depression
- Being tested
- OCAT-sham, OCAT, Psycho-education video, Motivational video
- Keywords
- Emotion Regulation, Attention Training, Psycho-education, Depression
- Medical subject headings
- Depression, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCAT-shamBehavioural
Placebo version of the online contingent attention training preceded by a psycho-education movieclip.
OCATBehavioural
Online contingent attention training preceded by a psycho-education movieclip.
Psycho-education videoOther
All groups watch a psycho-education video before the start of the 10-day attention training.
Motivational videoOther
Participants in the OCAT+ condition watch a short motivational video before each training session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: OCAT; Other: Psycho-education video; Other: Motivational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
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).
Measured: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
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').
Measured: pre-test (before starting the training), post-test (immediately after the training)
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.
Measured: pre-test (before starting the training), post-test (immediately after the training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start8 Mar 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 DepressionStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Alexianen Zorggroep Tienen, Universidad Complutense de Madrid
- Responsible party
- Sponsor
- Investigators
- Rudi De Raedt, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269433
- Sponsor's protocol ID
- 0G054-2021-07
- Status last verified
- May 2024
- First submitted
- 11 Feb 2022
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: * Individual participant data will not be available. * Other documents will be available: Statistical Analysis Plan, Study Protocol (upon request to the researchers).
Publications
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.
PubMed 30735680De 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.
PubMed 27064551
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Attention Training on Symptoms and Emotion Regulation in Depressive Patients: Validation of the Online Contingent Attention Training (OCAT).
- ClinicalTrials.gov ID
- NCT05269433
- Acronym / sponsor ID
- 0G054-2021-07
- Conditions
- Depression
- Keywords
- Emotion Regulation, Attention Training, Psycho-education, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Alexianen Zorggroep Tienen, Universidad Complutense de Madrid
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Mar 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PSE + OCAT-sham | Active comparator | Behavioral: OCAT-sham, Other: Psycho-education videoPsycho-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. |
| PSE + OCAT | Experimental | Behavioral: OCAT, Other: Psycho-education videoPsycho-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. |
| PSE + OCAT+ | Experimental | Behavioral: OCAT, Other: Psycho-education video, Other: Motivational videoPsycho-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of depressive disorder
- Admission to a psychiatric hospital (Alexianen PK, Tienen)
Key exclusion criteria (4 listed)
- Current psychotic disorder
- Current neurological impairments
- Current alcohol addiction
- Current treatment with antidepressants that has not yet been kept constant
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-shamPlacebo version of the online contingent attention training preceded by a psycho-education movieclip. | Behavioural | PSE + OCAT-sham |
| OCATOnline contingent attention training preceded by a psycho-education movieclip. | Behavioural | PSE + OCAT, PSE + OCAT+ |
| Psycho-education videoAll groups watch a psycho-education video before the start of the 10-day attention training. | Other | PSE + OCAT, PSE + OCAT+, PSE + OCAT-sham |
| Motivational videoParticipants in the OCAT+ condition watch a short motivational video before each training session. | Other | PSE + OCAT+ |
Primary outcome
Changes in depression symptoms
Time frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
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
Time frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
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
Time frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
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.
4 secondary outcomes
Changes in cognitive emotion regulation strategies
Time frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
Self-Esteem
Time frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)
Treatment Credibility and Expectancy
Time frame: pre-test (before starting the training), post-test (immediately after the training)
Changes in emotional attention
Time frame: pre-test (before starting the training), post-test (immediately after the training)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Background: PubMed 30735680Sanchez-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.
- Background: PubMed 27064551De 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.
- Individual participant dataSharing planned: No. * Individual participant data will not be available. * Other documents will be available: Statistical Analysis Plan, Study Protocol (upon request to the researchers).
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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.
Rudi De Raedt, Professor principal investigator
University Ghent
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCAT, Psycho-education video and Motivational video in people with Depression, run by University Ghent at 3 sites 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
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?
Changes in depression symptoms (time frame: pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)). The study lists 3 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 NCT05269433, 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 3 Jun 2024.