Clinical trial NCT03958487: An Executive/Monitoring Treatment Protocol on Everyday Life Activities
Official title: Training to Deal With Distractors and With Conflicting/Problem-solving Situations: An Executive/Monitoring Treatment Protocol on Everyday Life Activities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Damage
Executive Dysfunction
Anosognosia
Keywords: Activities of Daily Living
Brain Injuries/rehabilitation
Generalization (Psychology)
Brain Injuries/psychology
Feedback, Psychological/physiology
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Universidad de Granada
First posted: 2019-05-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with acquired brain damage and with cognitive deficits on executive/monitoring and self awareness,previously measured through neuropsychological screening
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of errors on trained ADL tasks at post-training phase compared to baseline phase.
timeFrame: 30-45 minutes
measure: Rate of old/new errors on trained ADL tasks at post-training phase.
timeFrame: 30-45 minutes
measure: Number of errors (target errors, distractor errors, conflicting errors) on trained ADL tasks with novel executive/monitoring requirements
timeFrame: 30-45 minutes
measure: Number of errors (target errors, distractor errors, conflicting errors) on the untrained ADL task at post-training phase compared to baseline phase
timeFrame: 20 minutes
measure: INECO Frontal Screening
timeFrame: 6-10 minutes
measure: WCPA The Weekly Calendar Planning Activity
timeFrame: 15-20 minutes
measure: WCST Wisconsin Card Sorting Test
timeFrame: 10-15 min
Secondary outcomes:
measure: Measure of anticipatory awareness about own ADL performance
timeFrame: 3 minutes.
measure: Measure of self awareness about own ADL performance
timeFrame: 3 minutes.
measure: Measure of general metacognitive knowledge measured with the "Patient Competency Rating Scale" (PCRS, Prigatano, 1980).
timeFrame: 15 minutes.
measure: Follow-up of the same measures described above, taken 8/10 weeks after the end of the treatment.
timeFrame: 100 minutes
measure: 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).
timeFrame: 150 minutes
Other outcomes:
measure: 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)
timeFrame: 20 minutes
Locations:
city: Málaga
country: Spain
facility: Hospital Universitario Marítimo Virgen de la Victoria (Torremolinos)
state: España
city: Granada
country: Spain
facility: Centro de Investigación Mente, Cerebro y Comportamiento (CIMCYC)
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves. Departamento de Medicina Física y Rehabilitación.
Study officials:
affiliation: University of Granada. Departamento de Psicología Experimental)
name: María Jesús Funes- Molina, Professor
role: PRINCIPAL_INVESTIGATOR
References: