Brain DamageNCT03958487
An Executive/Monitoring Treatment Protocol on Everyday Life Activities
A study testing Video feedback, Feedback online in people with Brain Damage and Executive Dysfunction, run by María Rodríguez Bailón at 3 sites in Spain.
Trial summary
Empirical research shows that deficits in executive/monitoring abilities (inhibition, error detection, problem solving) following acquired brain injury produce serious impact on patient's daily life performance. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brain Damage, Executive Dysfunction, Anosognosia
- What is being tested?
- Video feedback, Feedback online
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesSpain
- Study dates
- 29 Nov 2018to 28 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a chronic DCA (more than 3 months),
- Presence of cognitive deficits relative to executive/monitoring functions and/or memory evaluated by the team of professionals
- Age ≥ 18 years
Who cannot join
- Visuoperceptual deficits
- Attentional neglect
- Severe motor or perceptual alterations that impede the realization of activities of daily life
- Alterations of verbal comprehension
- Severe memory disturbances
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Centro de Investigación Mente, Cerebro y Comportamiento (CIMCYC)
Granada, 18011
Hospital Universitario Virgen de las Nieves. Departamento de Medicina Física y Rehabilitación.
Granada, 18013
Hospital Universitario Marítimo Virgen de la Victoria (Torremolinos)
Málaga, España, 29620
About this study
Official title: Training to Deal With Distractors and With Conflicting/Problem-solving Situations: An Executive/Monitoring Treatment Protocol on Everyday Life Activities
Empirical research shows that deficits in executive/monitoring abilities (inhibition, error detection, problem solving) following acquired brain injury produce serious impact on patient's daily life performance. The authors developed an intervention method aimed at improving "on-line" error detection and correction abilities during performance of naturalistic action. Patients will be asked to complete two significant everyday activities (e.g. making a sandwich and setting the kitchen table for four people) while increasing the level of monitoring requirements as their performance improve. Monitoring requirements increased by presenting new semantically and physically related distractors and increasing the number of conflicting/problem solving situations. The treatment involves a metacognitive contextual intervention program based on providing systematic online/offline-feedback on their own performance, with emphasis on making the patient aware of how to deal with distracting/conflicting situations that were previously failed. The authors predict that errors committed and addressed through the feedback sessions (errors, actions towards distractors, failures to detect/solve conflicting situations) will be reduced on post-intervention performance compared to baseline. The authors also expect behavioral improvements to generalize to trained tasks but adding new distractors/conflicting situations or even to untrained tasks.
Read the detailed description
This protocol will be applied to several acquired brain damage patients with executive/monitoring deficits. Baseline evaluation will take take around 5 sessions, The training phase will be done on 6 sessions and post-training evaluation will be completed on around 3 sessions. Each patient will be invited to be retested 8/10 weeks after completing the training, to evaluate long term effects (secondary outcome). The final number of participants enrolled in the study will depend on availability.
The authors will use a single case A-B changing criterium design: Phase A constitutes the base line. Three ADL tasks will be performed by the participant without help, two of them will be treated on phase B and the other will not be trained. Each task will be evaluated 3/4 times to obtain a robust baseline. Apart from ADL, other executive/monitoring measures will be obtained pre and post-training through neuropsychological screening.
The level of monitoring difficulty will be increasing from one training session to the next, from level 1 (2 distractors/1 conflicting situation) to level 3 (8 distractors/4 conflicting situations). Baseline and post-training performance will be evaluated at level 3.The criterion to increase the level of monitoring requirements will be adjusted to each individual depending on his/her performance on the previous level. Therefore, only if a given participant reduces on at least 75% the amount of errors from initial evaluation on the present training session he/she will be confronted with the next level of difficulty on the next session. However, if the patient doesn't reach the criterium, the same level of monitoring will be repeated and trained on the following session.
Outcomes measures (post-training phase) will be taken after completing 6 training sessions.
- Conditions
- Brain Damage, Executive Dysfunction, Anosognosia
- Being tested
- Video feedback, Feedback online
- Keywords
- Activities of Daily Living, Brain Injuries/rehabilitation, Generalization (Psychology), Brain Injuries/psychology, Feedback, Psychological/physiology
- Medical subject headings
- Brain Injuries, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video feedback, Feedback onlineBehavioural
Also called Metacognitive Training
The treatment phase have 3 timepoints, 1 the patient is asked to perform an ADL alone, 2. Video feedback is administrated. This requires the participant to watch its own videotaped performance with the therapist while the therapist encourage the participant to identify errors, areas of strength, and to suggest strategies to solve errors in future sessions. 3. feedback online will be provided by the therapist on participant performance. The therapist will wait for the patient to detect and correct their error spontaneously. If the patient does not detect it, the therapist provides unspecified/specific help. This strategy is based on previous work (Schmidt, et al 2013, Ownstorth et al. 2010). The novelty of our procedure is the inclusion of distracting and conflicting/problem solving situations to be inhibited, detected and solved. Feedback will focus on these situations. The level of monitoring requirements will be adjusted to participants performance using a changing criterion design.
| Study group | Role | What they receive |
|---|---|---|
| executive/monitoring training | Experimental | All participants will be part of the same group and their performance after treatment will be compared to their own performance prior to treatment (baseline) Receives: Behavioral: Video feedback, Feedback online |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of errors on trained ADL tasks at post-training phase compared to baseline phase.
Target errors will be coded based on the criteria developed by Humphreys and Forde (2002). Distractor errors will be considered whenever an action is directed to a non-target object. Finally, conflicting errors will be considered whenever a conflicting situation is not detected and/or solved correctly. The authors expect to find a significant reduction on the number of errors of every category (target errors, distractor errors and conflicting errors) committed on post-training performance of trained tasks compared to baseline measures of these tasks.
Measured: 30-45 minutes
Rate of old/new errors on trained ADL tasks at post-training phase.
The authors will codify errors as old/new, depending on whether they were already asdressed or not during the training sessions. The authors expect a reduced rate of old compared to new ones at the post-training phase.
Measured: 30-45 minutes
Number of errors (target errors, distractor errors, conflicting errors) on trained ADL tasks with novel executive/monitoring requirements
The authors expect to find a significant reduction on the number of errors of every type (target, distractor and conflicting errors) committed at post-training performance compared to baseline even when presenting new distractors and conflicting situations that were never encountered during the training sessions. This outcome will constitute a test of near transfer.
Measured: 30-45 minutes
Number of errors (target errors, distractor errors, conflicting errors) on the untrained ADL task at post-training phase compared to baseline phase
The authors expect to find a significant reduction on the number of errors o every type committed at post-training performance compared to performance at baseline, even in a task that was not trained. This outcome will constitute a test of far transfer
Measured: 20 minutes
INECO Frontal Screening
Executive functions. This screening test was designed to provide health professionals with a sensitive and specific executive screening test to determine frontal dysfunction. The authors expect to find a better performance in this test at the post-training phase compared to the baseline phase. This outcome will constitute a test of far transfer.
Measured: 6-10 minutes
WCPA The Weekly Calendar Planning Activity
This test includes the scheduling of meetings as part of a weekly planning, in total there are 10 appointments. The test provides a total error score and the ability to use problem-solving strategies.The authors expect to find a better performance in this test at the post-training phase compared to the baseline phase. This outcome will constitute a test of far transfer.
Measured: 15-20 minutes
WCST Wisconsin Card Sorting Test
Evaluates the capacity of abstraction, formation of concepts and the change of cognitive strategies in response to changes that occur in environmental contingencies.The authors expect to find a better performance in this test at the post-training phase compared to the baseline phase. This outcome will constitute a test of far transfer.
Measured: 10-15 min
Secondary outcomes (5)
Measure of anticipatory awareness about own ADL performance
Before performing every ADL task , the researcher will ask participants to evaluate how well they think they will perform (i.e. to predict the number of errors). This estimation will be compared with actual performance (number of errors committed). The difference between these two measures will constitute a measure of anticipatory awareness discrepancy, that could be positive (overestimation) or negative (underestimation). The authors expect that discrepancy in anticipatory awareness will be reduced after training compared to measures at baseline.
Measured: 3 minutes.
Measure of self awareness about own ADL performance
After completing every ADL patients will be asked which errors they think they have committed. This estimation will be compared with actual performance (actual number of errors committed). The difference between these two measures will constitute a measure of self awareness discrepancy on their ADL performance. The Authors expect that discrepancies between patients evaluations and their actual performance will be reduced after training.
Measured: 3 minutes.
Measure of general metacognitive knowledge measured with the "Patient Competency Rating Scale" (PCRS, Prigatano, 1980).
The PCRS is a 30-item self-report instrument which asks the subject to use a 5-point Likert scale to rate his or her degree of difficulty in a variety of tasks and functions. The subject's responses are compared to those of a significant other (a relative or therapist) who rates the subject on the identical items. Impaired self-awareness is inferred from discrepancies between the two ratings, such that the subject overestimates/underestimates his/ her abilities compared to the other informant. It includes items about competency in activities of daily living, behavioral and emotional function, cognitive abilities, and physical function.functional and cognitive competency. The authors expect that discrepancies between the patient and the caregiver will be reduced after training compared to these measures at baseline.
Measured: 15 minutes.
Follow-up of the same measures described above, taken 8/10 weeks after the end of the treatment.
The authors are interested at measuring potential long-term benefits of our intervention. To do so the authors will invite participants to be re-evaluated with most of the tests described above used at the immediate post-training phase. The authors expect to find that most improvements already present at the immediate post-training phase are still present at this follow-up time point.
Measured: 100 minutes
Caregiver daily registration of instrumental ADL performed by the patient during the Follow-up period (during the 8/10 weeks after the end of the treatment).
The authors will include a short questionnaire for direct caregivers where they will provide information about the number of ADL performed by the patient everyday. during this time period. This information will be analyzed as a potential mediator of follow-up outcomes.
Measured: 150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start29 Nov 2018
- Primary completion30 Oct 2020
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain DamageStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with acquired brain damage and with cognitive deficits on executive/monitoring and self awareness,previously measured through neuropsychological screening
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- María Rodríguez Bailón
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada
- Responsible party
- Sponsor-investigator, María Rodríguez Bailón, University of Malaga
- Investigators
- María Jesús Funes- Molina, Professor, Principal investigator, University of Granada. Departamento de Psicología Experimental)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958487
- Sponsor's protocol ID
- AnosognosiaAVD2017
- Status last verified
- Nov 2022
- First submitted
- 10 May 2019
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salazar-Frias D, Rodriguez-Bailon M, Ricchetti G, Navarro-Egido A, de Los Santos M, Funes MJ. Training to deal with distractions and conflicting situations in activities of daily living after traumatic brain injury (TBI): Preliminary evidence from a single-case experimental design study. Neuropsychol Rehabil. 2025 May;35(4):774-809. doi: 10.1080/09602011.2024.2375495. Epub 2024 Jul 15.
PubMed 39010748
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training to Deal With Distractors and With Conflicting/Problem-solving Situations: An Executive/Monitoring Treatment Protocol on Everyday Life Activities
- ClinicalTrials.gov ID
- NCT03958487
- Acronym / sponsor ID
- AnosognosiaAVD2017
- Conditions
- Brain Damage, Executive Dysfunction, Anosognosia
- Keywords
- Activities of Daily Living, Brain Injuries/rehabilitation, Generalization (Psychology), Brain Injuries/psychology, Feedback, Psychological/physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- María Rodríguez BailónUniversity, hospital or other
- Collaborators
- Universidad de Granada
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 22 May 2019 (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.
Empirical research shows that deficits in executive/monitoring abilities (inhibition, error detection, problem solving) following acquired brain injury produce serious impact on patient's daily life performance. The authors developed an intervention method aimed at improving "on-line" error detection and correction abilities during performance of naturalistic action. Patients will be asked to complete two significant everyday activities (e.g. making a sandwich and setting the kitchen table for four people) while increasing the level of monitoring requirements as their performance improve. Monitoring requirements increased by presenting new semantically and physically related distractors and increasing the number of conflicting/problem solving situations. The treatment involves a metacognitive contextual intervention program based on providing systematic online/offline-feedback on their own performance, with emphasis on making the patient aware of how to deal with distracting/conflicting situations that were previously failed. The authors predict that errors committed and addressed through the feedback sessions (errors, actions towards distractors, failures to detect/solve conflicting situations) will be reduced on post-intervention performance compared to baseline. The authors also expect behavioral improvements to generalize to trained tasks but adding new distractors/conflicting situations or even to untrained tasks.
Detailed description
This protocol will be applied to several acquired brain damage patients with executive/monitoring deficits. Baseline evaluation will take take around 5 sessions, The training phase will be done on 6 sessions and post-training evaluation will be completed on around 3 sessions. Each patient will be invited to be retested 8/10 weeks after completing the training, to evaluate long term effects (secondary outcome). The final number of participants enrolled in the study will depend on availability.
The authors will use a single case A-B changing criterium design: Phase A constitutes the base line. Three ADL tasks will be performed by the participant without help, two of them will be treated on phase B and the other will not be trained. Each task will be evaluated 3/4 times to obtain a robust baseline. Apart from ADL, other executive/monitoring measures will be obtained pre and post-training through neuropsychological screening.
The level of monitoring difficulty will be increasing from one training session to the next, from level 1 (2 distractors/1 conflicting situation) to level 3 (8 distractors/4 conflicting situations). Baseline and post-training performance will be evaluated at level 3.The criterion to increase the level of monitoring requirements will be adjusted to each individual depending on his/her performance on the previous level. Therefore, only if a given participant reduces on at least 75% the amount of errors from initial evaluation on the present training session he/she will be confronted with the next level of difficulty on the next session. However, if the patient doesn't reach the criterium, the same level of monitoring will be repeated and trained on the following session.
Outcomes measures (post-training phase) will be taken after completing 6 training sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with acquired brain damage and with cognitive deficits on executive/monitoring and self awareness,previously measured through neuropsychological screening
| Arm | Type | Receives |
|---|---|---|
| executive/monitoring training | Experimental | Behavioral: Video feedback, Feedback onlineAll participants will be part of the same group and their performance after treatment will be compared to their own performance prior to treatment (baseline) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of a chronic DCA (more than 3 months),
- Presence of cognitive deficits relative to executive/monitoring functions and/or memory evaluated by the team of professionals
- Age ≥ 18 years
Key exclusion criteria (5 listed)
- Visuoperceptual deficits
- Attentional neglect
- Severe motor or perceptual alterations that impede the realization of activities of daily life
- Alterations of verbal comprehension
- Severe memory disturbances
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 |
|---|---|---|
| Video feedback, Feedback onlineAlso: Metacognitive TrainingThe treatment phase have 3 timepoints, 1 the patient is asked to perform an ADL alone, 2. Video feedback is administrated. This requires the participant to watch its own videotaped performance with the therapist while the therapist encourage the participant to identify errors, areas of strength, and to suggest strategies to solve errors in future sessions. 3. feedback online will be provided by the therapist on participant performance. The therapist will wait for the patient to detect and correct their error spontaneously. If the patient does not detect it, the therapist provides unspecified/specific help. This strategy is based on previous work (Schmidt, et al 2013, Ownstorth et al. 2010). The novelty of our procedure is the inclusion of distracting and conflicting/problem solving situations to be inhibited, detected and solved. Feedback will focus on these situations. The level of monitoring requirements will be adjusted to participants performance using a changing criterion design. | Behavioural | executive/monitoring training |
Primary outcome
Number of errors on trained ADL tasks at post-training phase compared to baseline phase.
Time frame: 30-45 minutes
Target errors will be coded based on the criteria developed by Humphreys and Forde (2002). Distractor errors will be considered whenever an action is directed to a non-target object. Finally, conflicting errors will be considered whenever a conflicting situation is not detected and/or solved correctly. The authors expect to find a significant reduction on the number of errors of every category (target errors, distractor errors and conflicting errors) committed on post-training performance of trained tasks compared to baseline measures of these tasks.
Rate of old/new errors on trained ADL tasks at post-training phase.
Time frame: 30-45 minutes
The authors will codify errors as old/new, depending on whether they were already asdressed or not during the training sessions. The authors expect a reduced rate of old compared to new ones at the post-training phase.
Number of errors (target errors, distractor errors, conflicting errors) on trained ADL tasks with novel executive/monitoring requirements
Time frame: 30-45 minutes
The authors expect to find a significant reduction on the number of errors of every type (target, distractor and conflicting errors) committed at post-training performance compared to baseline even when presenting new distractors and conflicting situations that were never encountered during the training sessions. This outcome will constitute a test of near transfer.
Number of errors (target errors, distractor errors, conflicting errors) on the untrained ADL task at post-training phase compared to baseline phase
Time frame: 20 minutes
The authors expect to find a significant reduction on the number of errors o every type committed at post-training performance compared to performance at baseline, even in a task that was not trained. This outcome will constitute a test of far transfer
INECO Frontal Screening
Time frame: 6-10 minutes
Executive functions. This screening test was designed to provide health professionals with a sensitive and specific executive screening test to determine frontal dysfunction. The authors expect to find a better performance in this test at the post-training phase compared to the baseline phase. This outcome will constitute a test of far transfer.
WCPA The Weekly Calendar Planning Activity
Time frame: 15-20 minutes
This test includes the scheduling of meetings as part of a weekly planning, in total there are 10 appointments. The test provides a total error score and the ability to use problem-solving strategies.The authors expect to find a better performance in this test at the post-training phase compared to the baseline phase. This outcome will constitute a test of far transfer.
WCST Wisconsin Card Sorting Test
Time frame: 10-15 min
Evaluates the capacity of abstraction, formation of concepts and the change of cognitive strategies in response to changes that occur in environmental contingencies.The authors expect to find a better performance in this test at the post-training phase compared to the baseline phase. This outcome will constitute a test of far transfer.
5 secondary outcomes
Measure of anticipatory awareness about own ADL performance
Time frame: 3 minutes.
Measure of self awareness about own ADL performance
Time frame: 3 minutes.
Measure of general metacognitive knowledge measured with the "Patient Competency Rating Scale" (PCRS, Prigatano, 1980).
Time frame: 15 minutes.
Follow-up of the same measures described above, taken 8/10 weeks after the end of the treatment.
Time frame: 100 minutes
Caregiver daily registration of instrumental ADL performed by the patient during the Follow-up period (during the 8/10 weeks after the end of the treatment).
Time frame: 150 minutes
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 9 Nov 2022.
- Derived from this study: PubMed 39010748Salazar-Frias D, Rodriguez-Bailon M, Ricchetti G, Navarro-Egido A, de Los Santos M, Funes MJ. Training to deal with distractions and conflicting situations in activities of daily living after traumatic brain injury (TBI): Preliminary evidence from a single-case experimental design study. Neuropsychol Rehabil. 2025 May;35(4):774-809. doi: 10.1080/09602011.2024.2375495. Epub 2024 Jul 15.
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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.
María Jesús Funes- Molina, Professor principal investigator
University of Granada. Departamento de Psicología Experimental)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video feedback, Feedback online in people with Brain Damage and Executive Dysfunction, run by María Rodríguez Bailón at 3 sites 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 5 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 9 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 3 sites 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. 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?
Number of errors on trained ADL tasks at post-training phase compared to baseline phase. (time frame: 30-45 minutes). The study lists 7 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 NCT03958487, which also lists 1 linked publication.
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 9 Nov 2022.