An Executive/Monitoring Treatment Protocol on Everyday Life Activities

NCT ID: NCT03958487

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-29
• Study Completion Date: 2021-06-28

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.

Conditions

Brain Damage; Executive Dysfunction; Anosognosia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Video feedback, Feedback online

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Metacognitive Training

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Granada

OTHER

Sponsor Role: collaborator

María Rodríguez Bailón

OTHER

Sponsor Role: lead

Responsible Party

María Rodríguez Bailón

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

María Jesús Funes- Molina, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Granada. Departamento de Psicología Experimental)

Locations

Hospital Universitario Marítimo Virgen de la Victoria (Torremolinos)

Málaga, España, Spain

Centro de Investigación Mente, Cerebro y Comportamiento (CIMCYC)

Granada, , Spain

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

Granada, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 39010748 (View on PubMed)

Other Identifiers

AnosognosiaAVD2017

Identifier Type: -

Identifier Source: org_study_id