FibromyalgiaABMNCT05905159
Attentional Bias Modification in Fibromyalgia Patients (ABM)
A study testing ABM in people with Fibromyalgia, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
There is a growing interest in the potential benefits of attentional bias modification (ABM) training in chronic pain patients. However, studies examining the effectiveness of ABM programs in fibromyalgia patients have demonstrated inconclusive effects on both behavioral indices and clinical symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- ABM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jan 2023to 12 Mar 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibromyalgia Diagnosis.
- Female sex
- The presence of clinical symptoms regarding anxiety or depression will be not exclusion criteria, as long as fibromyalgia was participants' primary diagnosis.
Who cannot join
- Participation in the study will require the absence of neurological and psychiatric disorders that impair cognitive functions (i.e., stroke brain damage, psychosis, bipolar disorder, and substance abuse/dependence).
- Pregnancy
- Not being able to read Spanish in order to fill in the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural Mechanisms Underlying Attentional Bias Modification in Fibromyalgia Patients: a Double-blind ERP Study
There is a growing interest in the potential benefits of attentional bias modification (ABM) training in chronic pain patients. However, studies examining the effectiveness of ABM programs in fibromyalgia patients have demonstrated inconclusive effects on both behavioral indices and clinical symptoms. Underlying neural dynamics of ABM effects could yield additional insights but remain yet unexplored.
Current study, therefore, aimed investigating the effects of ABM training on known neural indicators of attentional bias to pain using electroencephalography (EEG).
Read more
The goal of this clinical trial is to test the effects of ABM training on known neural indicators of attentional bias to pain using electroencephalography (EEG) in fibromyalgia patients
The main question[s] it aims to answer are:
- Are fibromyalgia patients sensitive to ABM procedures?
- What are the neural indices associated with ABM procedures?
- Do ABM procedures transfer of effects on the clinical symptomatology in fibromyalgia patients?
Participants will performes five sessions consisting of a modified dot-probe task in which patients were trained to avoid facial pain expressions, whereas in the control group participants will performes five sessions consisting of a standard dot-probe task. Potential ABM training effects will be evaluated by comparing a single pre- and post-treatment session, in which event-related potentials (ERPs) will be recorded in response to three experimental tasks (standard dot-probe, RIR, and visual tasks).
Furthermore, patients will fill a series of self-report questionnaires assessing anxiety, depression, pain-related worrying, fear of pain, fatigue and pain status.
Researchers will compare two fibromyalgia patients groups that will enrolled and randomly assigned to an ABM training in order to see attentional improvements in the training fibromyalgia group.
- Conditions
- Fibromyalgia
- Being tested
- ABM, Control
- Keywords
- Attentional bias modification, Dot-Probe Task, Fibromyalgia, ERPs, Pain-related Faces
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABMBehavioural
Direct attention away from pain-related information (i.e., facial expressions) through implicit training procedures
ControlBehavioural
Direct attention equally towards pain-related and neutral information (i.e., facial expressions) through implicit training procedures
| Study group | Role | What they receive |
|---|---|---|
| ABM | Experimental | ABM training will consist of five sessions over five consecutive days during which patients performed a modified version of the visual dot-probe task. The whole ABM program will include a total of 1000 trials that will be distributed in 200 trials per session (twenty minutes per session).
Participants assigned to ABM training condition will be trained implicitly to attend away from pain-related stimuli (i.e., facial expressions). They will be presented with a modified dot-probe task with trials including targets that often replaced neutral faces. Thus, 80% of trials (i.e., 160 trials) included targets that replaced neutral cue faces (pain incongruent trials: target appeared in the opposite side of pain-related faces). The rest of trials (i.e., 40 trials) belonged to pain congruent trials (i.e., target will occur in the same location of the pain-related facial expression). Receives: Behavioral: ABM |
| Control | Placebo comparator | By contrast, patients assigned to control condition were exposed to a standard visual dot-probe task in which targets were equally likely to replace pain or neutral cues (i.e., facial expressions) during pain trials (i.e., 50% pain-incongruent trials and 50% pain-congruent tri-als). The whole Control program will include a total of 1000 trials that will be distributed in 200 trials per session (twenty minutes per session). Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional bias from baseline (pre-training)
Attentional bias will be assessed by dot-probe task. Behavioural reaction times outcomes will be recorder. The reaction time average for each dot-probe condition will be included as intrasubject factor and the training group as between-subject factor.
Measured: Behavioural Attentional bias from baseline (pre-training)
Attentional bias from baseline (pre-training)
Attentional bias will be assessed by dot-probe task. Event-related potentials (ERPs) outcomes will be recorder. The P2 and N2 ERPs average amplitudes for each dot-probe condition will be included as intrasubject factor and the training group as between-subject factor.
Measured: ERPs Attentional bias from baseline (pre-training)
Changes on Attentional bias from baseline (pre-training) to 1 day post-training
Attentional bias will be assessed by dot-probe task. Behavioural reaction times outcomes will be recorder. To test the effect of the ABM procedure, the reaction time average for each dot-probe condition will be included as intrasubject factor and the training group as between-subject factor.
Measured: Behavioural attentional bias modification changes from baseline (pre-training vs 1 day post-training)
Changes on Attentional bias from baseline (pre-training) to 1 day post-training
Attentional bias will be assessed by dot-probe task. ERPs outcomes will be recorder. To test the effect of the ABM procedure, ERPs amplitudes for each dot-probe condition will be included as intrasubject factor and the training group as between-subject factor.
Measured: ERPs attentional bias modification changes from baseline (pre-training vs 1 day post-training)
Secondary outcomes (7)
Anxiety scores from baseline (pre-training) to 1 day post-training
Anxiety will be assessed by the Spanish version of the State-Trait Anxiety Inventory (STAI) questionnaire. The scale include 20 items and are scored using a four-point Likert scale, ranging from 0 to 3. Higher scores (i.e., > 60 percentile) represents high anxiety levels. Anxiety scores will be included as intrasubject factor and the training group as between-subject factor.
Measured: Anxiety scores from baseline changes from baseline (pre-training vs 1 day post-training)
Depression scores from baseline (pre-training) to 1 day post-training
Depression will be assessed by the Spanish version of the Beck Depression Inventory (BDI). The scale include 21 items with four different statements describing various degrees of symptom intensity. Higher scores (i.e., > 21) represents greater severity of depressive symptoms. Depression scores will be included as intrasubject factor and the training group as between-subject factor.
Measured: Depression scores from baseline changes from baseline (pre-training vs 1 day post-training)
Fear of pain scores from baseline (pre-training) to 1 day post-training
Fear of pain will be assessed by the Spanish version of Fear of Pain Questionnaire (FPQ). In FPQ questionnaire participants are asked to rate in 30 items how fearful to pain experiences on a 5-point Likert scale. Higher scores represents greater severity of fear of pain symptoms. Fear of pain scores will be included as intrasubject factor and the training group as between-subject factor.
Measured: Fear of pain scores from baseline changes from baseline (pre-training vs 1 day post-training)
Pain worrying scores from baseline (pre-training) to 1 day post-training
Pain worrying will be assessed by the Spanish versions of the Pain Catastrophizing Scale (PCS). In this scale, participants rated in 13 items the frequency of experiencing each catastrophic belief on a 0 to 4 Likert scale. Higher scores represents greater severity of pain worrying symptoms. Pain worrying scores will be included as intrasubject factor and the training group as between-subject factor.
Measured: Pain worrying scores from baseline changes from baseline (pre-training vs 1 day post-training)
Fibromyalgia impact scores from baseline (pre-training) to 1 day post-training
Fibromyalgia impact will be assessed by the Spanish version of the Fibromyalgia Impact Questionnaire (FIQ). FIQ consists of 10 items for the assessment of three fibromyalgia domains (function, overall impact and symptoms). Higher scores represents greater severity of fibromyalgia impact symptoms. Fibromyalgia impact scores will be included as intrasubject factor and the training group as between-subject factor.
Measured: Fibromyalgia impact scores from baseline changes from baseline (pre-training vs 1 day post-training)
Pain scores from baseline (pre-training) to 1 day post-training
Pain status will be assessed by a visual analogue scale (VAS). The scale include 0 to 10 likert scale. Higher scores (i.e., > 6) represents greater severity of pain intensity symptoms. Pain scores will be included as intrasubject factor and the training group as between-subject factor.
Measured: Pain scores from baseline changes from baseline (pre-training vs 1 day post-training)
Fatigue scores from baseline (pre-training) to 1 day post-training
Fatigue status will be assessed by a visual analogue scale (VAS). The scale include 0 to 10 likert scale. Higher scores (i.e., > 6) represents greater severity of fatigue intensity symptoms. Fatigue scores will be included as intrasubject factor and the training group as between-subject factor.
Measured: Fatigue scores from baseline changes from baseline (pre-training vs 1 day post-training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start12 Jan 2023
- Primary completion23 Feb 2023
- Study completion12 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Francisco Mercado, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905159
- Sponsor's protocol ID
- ABM-URJC
- Acronym
- ABM
- Status last verified
- Jun 2023
- First submitted
- 30 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carlson JM. A systematic review of event-related potentials as outcome measures of attention bias modification. Psychophysiology. 2021 Jun;58(6):e13801. doi: 10.1111/psyp.13801. Epub 2021 Mar 8.
PubMed 33682161Eldar S, Bar-Haim Y. Neural plasticity in response to attention training in anxiety. Psychol Med. 2010 Apr;40(4):667-77. doi: 10.1017/S0033291709990766. Epub 2009 Jul 23.
PubMed 19627649Carleton RN, Asmundson GJG, Korol SL, LeBouthillier DM, Hozempa K, Katz JD, Vlaeyen JWS, Crombez G. Evaluating the efficacy of an attention modification program for patients with fibromyalgia: a randomized controlled trial. Pain. 2020 Mar;161(3):584-594. doi: 10.1097/j.pain.0000000000001746.
PubMed 31693540Crombez G, Van Ryckeghem DML, Eccleston C, Van Damme S. Attentional bias to pain-related information: a meta-analysis. Pain. 2013 Apr;154(4):497-510. doi: 10.1016/j.pain.2012.11.013. Epub 2012 Dec 5.
PubMed 23333054Fernandes-Magalhaes R, Ferrera D, Pelaez I, Martin-Buro MC, Carpio A, De Lahoz ME, Barjola P, Mercado F. Neural correlates of the attentional bias towards pain-related faces in fibromyalgia patients: An ERP study using a dot-probe task. Neuropsychologia. 2022 Feb 10;166:108141. doi: 10.1016/j.neuropsychologia.2021.108141. Epub 2022 Jan 4.
PubMed 34995568Mogoase C, David D, Koster EH. Clinical efficacy of attentional bias modification procedures: an updated meta-analysis. J Clin Psychol. 2014 Dec;70(12):1133-57. doi: 10.1002/jclp.22081. Epub 2014 Mar 20.
PubMed 24652823Todd J, Sharpe L, Johnson A, Nicholson Perry K, Colagiuri B, Dear BF. Towards a new model of attentional biases in the development, maintenance, and management of pain. Pain. 2015 Sep;156(9):1589-1600. doi: 10.1097/j.pain.0000000000000214.
PubMed 26291997Fernandes-Magalhaes R, Carpio A, Ferrera D, Pelaez I, De Lahoz ME, Van Ryckeghem D, Van Damme S, Mercado F. Neural mechanisms underlying attentional bias modification in fibromyalgia patients: a double-blind ERP study. Eur Arch Psychiatry Clin Neurosci. 2024 Aug;274(5):1197-1213. doi: 10.1007/s00406-023-01709-4. Epub 2023 Nov 19.
PubMed 37980687
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms Underlying Attentional Bias Modification in Fibromyalgia Patients: a Double-blind ERP Study
- ClinicalTrials.gov ID
- NCT05905159
- Acronym / sponsor ID
- ABM / ABM-URJC
- Conditions
- Fibromyalgia
- Keywords
- Attentional bias modification, Dot-Probe Task, Fibromyalgia, ERPs, Pain-related Faces
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 15 Jun 2023 (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.
There is a growing interest in the potential benefits of attentional bias modification (ABM) training in chronic pain patients. However, studies examining the effectiveness of ABM programs in fibromyalgia patients have demonstrated inconclusive effects on both behavioral indices and clinical symptoms. Underlying neural dynamics of ABM effects could yield additional insights but remain yet unexplored.
Current study, therefore, aimed investigating the effects of ABM training on known neural indicators of attentional bias to pain using electroencephalography (EEG).
The goal of this clinical trial is to test the effects of ABM training on known neural indicators of attentional bias to pain using electroencephalography (EEG) in fibromyalgia patients
The main question[s] it aims to answer are:
- Are fibromyalgia patients sensitive to ABM procedures?
- What are the neural indices associated with ABM procedures?
- Do ABM procedures transfer of effects on the clinical symptomatology in fibromyalgia patients?
Participants will performes five sessions consisting of a modified dot-probe task in which patients were trained to avoid facial pain expressions, whereas in the control group participants will performes five sessions consisting of a standard dot-probe task. Potential ABM training effects will be evaluated by comparing a single pre- and post-treatment session, in which event-related potentials (ERPs) will be recorded in response to three experimental tasks (standard dot-probe, RIR, and visual tasks).
Furthermore, patients will fill a series of self-report questionnaires assessing anxiety, depression, pain-related worrying, fear of pain, fatigue and pain status.
Researchers will compare two fibromyalgia patients groups that will enrolled and randomly assigned to an ABM training in order to see attentional improvements in the training fibromyalgia group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABM | Experimental | Behavioral: ABMABM training will consist of five sessions over five consecutive days during which patients performed a modified version of the visual dot-probe task. The whole ABM program will include a total of 1000 trials that will be distributed in 200 trials per session (twenty minutes per session). Participants assigned to ABM training condition will be trained implicitly to attend away from pain-related stimuli (i.e., facial expressions). They will be presented with a modified dot-probe task with trials including targets that often replaced neutral faces. Thus, 80% of trials (i.e., 160 trials) included targets that replaced neutral cue faces (pain incongruent trials: target appeared in the opposite side of pain-related faces). The rest of trials (i.e., 40 trials) belonged to pain congruent trials (i.e., target will occur in the same location of the pain-related facial expression). |
| Control | Placebo comparator | Behavioral: ControlBy contrast, patients assigned to control condition were exposed to a standard visual dot-probe task in which targets were equally likely to replace pain or neutral cues (i.e., facial expressions) during pain trials (i.e., 50% pain-incongruent trials and 50% pain-congruent tri-als). The whole Control program will include a total of 1000 trials that will be distributed in 200 trials per session (twenty minutes per session). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fibromyalgia Diagnosis.
- Female sex
- The presence of clinical symptoms regarding anxiety or depression will be not exclusion criteria, as long as fibromyalgia was participants' primary diagnosis.
Key exclusion criteria (3 listed)
- Participation in the study will require the absence of neurological and psychiatric disorders that impair cognitive functions (i.e., stroke brain damage, psychosis, bipolar disorder, and substance abuse/dependence).
- Pregnancy
- Not being able to read Spanish in order to fill in the questionnaires
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 |
|---|---|---|
| ABMDirect attention away from pain-related information (i.e., facial expressions) through implicit training procedures | Behavioural | ABM |
| ControlDirect attention equally towards pain-related and neutral information (i.e., facial expressions) through implicit training procedures | Behavioural | Control |
Primary outcome
Attentional bias from baseline (pre-training)
Time frame: Behavioural Attentional bias from baseline (pre-training)
Attentional bias will be assessed by dot-probe task. Behavioural reaction times outcomes will be recorder. The reaction time average for each dot-probe condition will be included as intrasubject factor and the training group as between-subject factor.
Attentional bias from baseline (pre-training)
Time frame: ERPs Attentional bias from baseline (pre-training)
Attentional bias will be assessed by dot-probe task. Event-related potentials (ERPs) outcomes will be recorder. The P2 and N2 ERPs average amplitudes for each dot-probe condition will be included as intrasubject factor and the training group as between-subject factor.
Changes on Attentional bias from baseline (pre-training) to 1 day post-training
Time frame: Behavioural attentional bias modification changes from baseline (pre-training vs 1 day post-training)
Attentional bias will be assessed by dot-probe task. Behavioural reaction times outcomes will be recorder. To test the effect of the ABM procedure, the reaction time average for each dot-probe condition will be included as intrasubject factor and the training group as between-subject factor.
Changes on Attentional bias from baseline (pre-training) to 1 day post-training
Time frame: ERPs attentional bias modification changes from baseline (pre-training vs 1 day post-training)
Attentional bias will be assessed by dot-probe task. ERPs outcomes will be recorder. To test the effect of the ABM procedure, ERPs amplitudes for each dot-probe condition will be included as intrasubject factor and the training group as between-subject factor.
7 secondary outcomes
Anxiety scores from baseline (pre-training) to 1 day post-training
Time frame: Anxiety scores from baseline changes from baseline (pre-training vs 1 day post-training)
Depression scores from baseline (pre-training) to 1 day post-training
Time frame: Depression scores from baseline changes from baseline (pre-training vs 1 day post-training)
Fear of pain scores from baseline (pre-training) to 1 day post-training
Time frame: Fear of pain scores from baseline changes from baseline (pre-training vs 1 day post-training)
Pain worrying scores from baseline (pre-training) to 1 day post-training
Time frame: Pain worrying scores from baseline changes from baseline (pre-training vs 1 day post-training)
Fibromyalgia impact scores from baseline (pre-training) to 1 day post-training
Time frame: Fibromyalgia impact scores from baseline changes from baseline (pre-training vs 1 day post-training)
Pain scores from baseline (pre-training) to 1 day post-training
Time frame: Pain scores from baseline changes from baseline (pre-training vs 1 day post-training)
Fatigue scores from baseline (pre-training) to 1 day post-training
Time frame: Fatigue scores from baseline changes from baseline (pre-training vs 1 day post-training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 33682161Carlson JM. A systematic review of event-related potentials as outcome measures of attention bias modification. Psychophysiology. 2021 Jun;58(6):e13801. doi: 10.1111/psyp.13801. Epub 2021 Mar 8.
- Background: PubMed 19627649Eldar S, Bar-Haim Y. Neural plasticity in response to attention training in anxiety. Psychol Med. 2010 Apr;40(4):667-77. doi: 10.1017/S0033291709990766. Epub 2009 Jul 23.
- Background: PubMed 31693540Carleton RN, Asmundson GJG, Korol SL, LeBouthillier DM, Hozempa K, Katz JD, Vlaeyen JWS, Crombez G. Evaluating the efficacy of an attention modification program for patients with fibromyalgia: a randomized controlled trial. Pain. 2020 Mar;161(3):584-594. doi: 10.1097/j.pain.0000000000001746.
- Background: PubMed 23333054Crombez G, Van Ryckeghem DML, Eccleston C, Van Damme S. Attentional bias to pain-related information: a meta-analysis. Pain. 2013 Apr;154(4):497-510. doi: 10.1016/j.pain.2012.11.013. Epub 2012 Dec 5.
- Background: PubMed 34995568Fernandes-Magalhaes R, Ferrera D, Pelaez I, Martin-Buro MC, Carpio A, De Lahoz ME, Barjola P, Mercado F. Neural correlates of the attentional bias towards pain-related faces in fibromyalgia patients: An ERP study using a dot-probe task. Neuropsychologia. 2022 Feb 10;166:108141. doi: 10.1016/j.neuropsychologia.2021.108141. Epub 2022 Jan 4.
- Background: PubMed 24652823Mogoase C, David D, Koster EH. Clinical efficacy of attentional bias modification procedures: an updated meta-analysis. J Clin Psychol. 2014 Dec;70(12):1133-57. doi: 10.1002/jclp.22081. Epub 2014 Mar 20.
- Background: PubMed 26291997Todd J, Sharpe L, Johnson A, Nicholson Perry K, Colagiuri B, Dear BF. Towards a new model of attentional biases in the development, maintenance, and management of pain. Pain. 2015 Sep;156(9):1589-1600. doi: 10.1097/j.pain.0000000000000214.
- Derived from this study: PubMed 37980687Fernandes-Magalhaes R, Carpio A, Ferrera D, Pelaez I, De Lahoz ME, Van Ryckeghem D, Van Damme S, Mercado F. Neural mechanisms underlying attentional bias modification in fibromyalgia patients: a double-blind ERP study. Eur Arch Psychiatry Clin Neurosci. 2024 Aug;274(5):1197-1213. doi: 10.1007/s00406-023-01709-4. Epub 2023 Nov 19.
- 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.
Francisco Mercado, PhD principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABM in people with Fibromyalgia, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 15 Jun 2023. 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 Spain. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Attentional bias from baseline (pre-training) (time frame: Behavioural Attentional bias from baseline (pre-training)). The study lists 4 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 NCT05905159, which also lists 8 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 15 Jun 2023.