Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Damage Executive Dysfunction Anosognosia | Behavioral: Video feedback, Feedback online | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention 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) |
Masking Description: | Patients will not be informed about the phases of the study they are in (baseline, treatment, post-treatment, follow-up) |
Primary Purpose: | Treatment |
Official Title: | Training to Deal With Distractors and With Conflicting/Problem-solving Situations: An Executive/Monitoring Treatment Protocol on Everyday Life Activities |
Actual Study Start Date : | November 29, 2018 |
Actual Primary Completion Date : | October 30, 2020 |
Estimated Study Completion Date : | June 28, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: executive/monitoring training
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)
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Behavioral: Video feedback, Feedback online
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.
Other Name: Metacognitive Training
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: María Jesús Funes Molina, Professor | 958247884 | mjfunes@ugr.es | |
Contact: María Rodríguez Bailón | mariarbailon@uma.es |
Spain | |
Hospital Universitario Marítimo Virgen de la Victoria (Torremolinos) | Recruiting |
Málaga, España, Spain, 29620 | |
Contact: Raquel Navas-Fernández, Máster | |
Sub-Investigator: Daniel Salazar, ph.D student | |
Sub-Investigator: Giorgia Richetti, ph.D student | |
Sub-Investigator: Jose Antonio Merchán Baeza, ph.D student | |
Principal Investigator: Maria J. Funes, ph.D | |
Sub-Investigator: Alba Navarro Egido, Máster | |
Sub-Investigator: Maria Rodríguez Bailón, PhD | |
Centro de Investigación Mente, Cerebro y Comportamiento (CIMCYC) | Recruiting |
Granada, Spain, 18011 | |
Contact: Maria J. Funes, PhD | |
Sub-Investigator: Giorgia Richetti, Phd Student | |
Sub-Investigator: Daniel Salazar, Phd Student | |
Sub-Investigator: Alba Navarro Egido, Máster | |
Sub-Investigator: Jose Antonio Merchán-Baeza, PhD | |
Sub-Investigator: María Rodríguez-Bailón, PhD | |
Principal Investigator: Maria J. Funes, PhD | |
Hospital Universitario Virgen de las Nieves. Departamento de Medicina Física y Rehabilitación. | Recruiting |
Granada, Spain, 18013 | |
Contact: Patrocinio Ariza-Vega pariza@ugr.es | |
Sub-Investigator: Daniel Salazar, ph. Student | |
Sub-Investigator: Giorgia Richetti, ph. Student | |
Sub-Investigator: María Rodríguez Bailón, ph.D | |
Sub-Investigator: Jose Antonio Merchán Baeza, ph.D | |
Sub-Investigator: Alba Navarro Egido, master | |
Sub-Investigator: Patrocinio Ariza-Vega, ph.D | |
Principal Investigator: María J. Funes, ph.D |
Principal Investigator: | María Jesús Funes- Molina, Professor | University of Granada. Departamento de Psicología Experimental) |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 10, 2019 | ||||||||
First Posted Date ICMJE | May 22, 2019 | ||||||||
Last Update Posted Date | November 4, 2020 | ||||||||
Actual Study Start Date ICMJE | November 29, 2018 | ||||||||
Actual Primary Completion Date | October 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
Measures of emotional distress at post-training compared to these measures at baseline with the The Depression Anxiety Stress Scale (DASS-21, Lovibond & Lovibond, 1995) [ Time Frame: 20 minutes ] The DASS-21, is a well-established instrument to measure symptoms of depression, anxiety and stress in both clinical and non-clinical samples of adults. It includes a total of 21 items, 7 items per subscale: depression, anxiety and stress. Patients are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much). Sum scores are computed by adding up the scores on the items per (sub)scale and multiplying them by a factor 2. Sum scores for the total DASS-total scale thus range between 0 and 120, and those for each of the subscales may range between 0 and 42. Cut-off scores of 60 and 21 are used for the total DASS score and for the depression subscale respectively. The scale will be administrated to patients pre and post intervention in order to asses changes in emotional distress due to training. Based on previous research using similar feedback training methodology with ADL no changes are expected.
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | An Executive/Monitoring Treatment Protocol on Everyday Life Activities | ||||||||
Official Title ICMJE | Training to Deal With Distractors and With Conflicting/Problem-solving Situations: An Executive/Monitoring Treatment Protocol on Everyday Life Activities | ||||||||
Brief 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. 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention 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)Masking Description: Patients will not be informed about the phases of the study they are in (baseline, treatment, post-treatment, follow-up) Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Video feedback, Feedback online
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.
Other Name: Metacognitive Training
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Study Arms ICMJE | Experimental: executive/monitoring training
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)
Intervention: Behavioral: Video feedback, Feedback online
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
6 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 28, 2021 | ||||||||
Actual Primary Completion Date | October 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Spain | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03958487 | ||||||||
Other Study ID Numbers ICMJE | AnosognosiaAVD2017 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | María Rodríguez Bailón, University of Malaga | ||||||||
Study Sponsor ICMJE | María Rodríguez Bailón | ||||||||
Collaborators ICMJE | Universidad de Granada | ||||||||
Investigators ICMJE |
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PRS Account | University of Malaga | ||||||||
Verification Date | November 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |