An Executive/Monitoring Treatment Protocol on Everyday Life Activities
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|ClinicalTrials.gov Identifier: NCT03958487|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : November 4, 2020
|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|
|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)|
|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|
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)
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
- 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.
- Measure of anticipatory awareness about own ADL performance [ Time Frame: 3 minutes. ]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.
- Measure of self awareness about own ADL performance [ Time Frame: 3 minutes. ]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.
- Measure of general metacognitive knowledge measured with the "Patient Competency Rating Scale" (PCRS, Prigatano, 1980). [ Time Frame: 15 minutes. ]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.
- Follow-up of the same measures described above, taken 8/10 weeks after the end of the treatment. [ Time Frame: 100 minutes ]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.
- 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 ]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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958487
|Contact: María Jesús Funes Molina, Professorfirstname.lastname@example.org|
|Contact: María Rodríguez Bailónemail@example.com|
|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 firstname.lastname@example.org|
|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)|