An Executive/Monitoring Treatment Protocol on Everyday Life Activities

NCT03958487 | Completed

• 1 other identifier: AnosognosiaAVD2017
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

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.

Conditions

Brain Damage; Executive Dysfunction; Anosognosia

Keywords

Activities of Daily Living; Brain Injuries/rehabilitation; Generalization (Psychology); Brain Injuries/psychology; Feedback, Psychological/physiology

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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

  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.

  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.

  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.

  10-15 min

Secondary Outcomes (5)

• Measure of anticipatory awareness about own ADL performance

  3 minutes.

• Measure of self awareness about own ADL performance

  3 minutes.

• Measure of general metacognitive knowledge measured with the "Patient Competency Rating Scale" (PCRS, Prigatano, 1980).

  15 minutes.

• Follow-up of the same measures described above, taken 8/10 weeks after the end of the treatment.

  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).

  150 minutes

Other Outcomes (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)

  20 minutes

Study Arms (1)

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)

Behavioral: Video feedback, Feedback online

Interventions

Video feedback, Feedback online BEHAVIORAL

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.

Also known as: Metacognitive Training

executive/monitoring training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• María Rodríguez Bailón: lead
• Universidad de Granada: collaborator

Study Sites (3)

Hospital Universitario Marítimo Virgen de la Victoria (Torremolinos)

Málaga, España, 29620, Spain

Location

Centro de Investigación Mente, Cerebro y Comportamiento (CIMCYC)

Granada, 18011, Spain

Location

Hospital Universitario Virgen de las Nieves. Departamento de Medicina Física y Rehabilitación.

Granada, 18013, Spain

Location

Related Publications (1)

• 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.

  PMID: 39010748 DERIVED

MeSH Terms

Conditions

Brain Injuries; Agnosia

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Officials

• María Jesús Funes- Molina, Professor

  University of Granada. Departamento de Psicología Experimental)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients will not be informed about the phases of the study they are in (baseline, treatment, post-treatment, follow-up)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Patients with acquired brain damage and with cognitive deficits on executive/monitoring and self awareness,previously measured through neuropsychological screening

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 22, 2019
• Study Start: November 29, 2018
• Primary Completion: October 30, 2020
• Study Completion: June 28, 2021
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

ES (3)