Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Executive/Monitoring Treatment Protocol on Everyday Life Activities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03958487
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Universidad de Granada
Information provided by (Responsible Party):
María Rodríguez Bailón, University of Malaga

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.

Condition or disease Intervention/treatment Phase
Brain Damage Executive Dysfunction Anosognosia Behavioral: Video feedback, Feedback online Not Applicable

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.


Layout table for study information
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)
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
Estimated Primary Completion Date : November 28, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


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)
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: María Jesús Funes Molina, Professor 958247884 mjfunes@ugr.es
Contact: María Rodríguez Bailón mariarbailon@uma.es

Locations
Layout table for location information
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         
Sponsors and Collaborators
María Rodríguez Bailón
Universidad de Granada
Investigators
Layout table for investigator information
Principal Investigator: María Jesús Funes- Molina, Professor University of Granada. Departamento de Psicología Experimental)

Layout table for additonal information
Responsible Party: María Rodríguez Bailón, Professor, University of Malaga
ClinicalTrials.gov Identifier: NCT03958487     History of Changes
Other Study ID Numbers: AnosognosiaAVD2017
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by María Rodríguez Bailón, University of Malaga:
Activities of Daily Living
Brain Injuries/rehabilitation
Generalization (Psychology)
Brain Injuries/psychology
Feedback, Psychological/physiology

Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Agnosia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms