Clinical trial NCT03183453: Neuropsychological Rehabilitation of Spontaneous Confabulation: a Replica Study
Official title: Replica Study of a Neuropsychological Treatment for Patients Who Show Spontaneous Confabulation After Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Disorders
Keywords: Confabulations
Neuropsychological rehabilitation
Memory
Lead sponsor: San Rafael University Hospital, Granada, Spain
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 57
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Confabulators consistently generate false memories without intention to deceive and with great feeling of rightness. However, there is currently no known effective treatment for them. In order to fill this gap, we performed a neuropsychological treatment in two groups of confabulators: experimental vs. control (ClinicalTrials.gov ID: NCT02540772).

Now, we intend to replicate the treatment with a larger sample of confabulators and with other two control groups: non-confabulator patients with brain injury and healthy individuals

Detailed description: The treatment consisted of some brief material that patients had to learn and recall at both immediate and delayed moments. After both recollections, patients were given feedback about their performance (errors and correct responses). Pre-treatment and post-treatment measurements were administered.

Non-confabulator patients and healthy participants performed only the pre-treatment measurement.

Eligibility criteria: Inclusion Criteria:

* The presence of spontaneous confabulations after acute brain injury, for at least three months and without clinical improvement (interfering with the patient's daily life with frequent arguments and exhaustive supervision).
* The presence of momentary confabulations in the Spanish adaptation of Dalla Barba provoked confabulation interview.
* Prior to injury, all patients should be completely independent for daily living.

Exclusion Criteria:

* The presence of impairment in alertness.
* Dementia.
* Acute confusional state.
* A history of drug abuse.
* Psychiatric antecedents.

Primary outcomes:
measure: Change in the number of Confabulations
timeFrame: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).
measure: Change in the number of correct responses
timeFrame: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).
measure: Change in the number of non-responses
timeFrame: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).
Secondary outcomes:
measure: Change in the number of errors in source attribution
timeFrame: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).
Other outcomes:
Locations:
city: Granada
country: Spain
facility: San Rafael University Hospital
Study officials:
affiliation: San Rafael University Hospital
name: Monica Triviño, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gilboa A, Alain C, Stuss DT, Melo B, Miller S, Moscovitch M. Mechanisms of spontaneous confabulations: a strategic retrieval account. Brain. 2006 Jun;129(Pt 6):1399-414. doi: 10.1093/brain/awl093. Epub 2006 Apr 25.
citation: Trivino M, Rodenas E, Lupianez J, Arnedo M. Effectiveness of a neuropsychological treatment for confabulations after brain injury: A clinical trial with theoretical implications. PLoS One. 2017 Mar 3;12(3):e0173166. doi: 10.1371/journal.pone.0173166. eCollection 2017.
citation: Schnider A. The confabulating mind. How the brain creates reality. Oxford: Oxford University Press; 2008
citation: Nahum L, Bouzerda-Wahlen A, Guggisberg A, Ptak R, Schnider A. Forms of confabulation: dissociations and associations. Neuropsychologia. 2012 Aug;50(10):2524-34. doi: 10.1016/j.neuropsychologia.2012.06.026. Epub 2012 Jul 7.
citation: Ciaramelli E, Ghetti S, Borsotti M. Divided attention during retrieval suppresses false recognition in confabulation. Cortex. 2009 Feb;45(2):141-53. doi: 10.1016/j.cortex.2007.10.006. Epub 2008 Feb 6.