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Neuropsychological Rehabilitation of Spontaneous Confabulation: a Replica Study

Primary Purpose

Memory Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neuropsychological treatment
Sponsored by
Monica Triviño Mosquera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Memory Disorders focused on measuring Confabulations, Neuropsychological rehabilitation, Memory

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • San Rafael University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Neuropsychological treatment

Non-confabulators control group

Healthy control group

Arm Description

The tested treatment is a combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.

Non-confabulators (brain injured patients but without confabulations) in this control group only performed the pre- and post-measurements without treatment.

Healthy participants in this control group only performed the pre- and post-measurements without treatment.

Outcomes

Primary Outcome Measures

Change in the number of Confabulations
The confabulations recorded were 1) guessed answers, 2) confusions in time and space, 3) a mixture of two or more stimuli presented, and 4) devised or bizarre responses. Scores ranged from 0 (no confabulations) to unlimited number of them (because devised or bizarre responses were recorded) and consisted of the sum of all the confabulations produced during the 3 sessions.
Change in the number of correct responses
Scores ranged from 0 (no correct answers) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).
Change in the number of non-responses
Scores ranged from 0 (no non-responses) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).

Secondary Outcome Measures

Change in the number of errors in source attribution
After the recall of the material, patients were also asked to remember which modality corresponded to each recall (i.e., seen, heard or imagined), and who had presented the material during the learning session (i.e., the therapist or themselves). Scores ranged from 0 (if all answers were non-responses) to unlimited number (depending on number of confabulations produced by patients).

Full Information

First Posted
April 25, 2017
Last Updated
May 25, 2018
Sponsor
Monica Triviño Mosquera
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1. Study Identification

Unique Protocol Identification Number
NCT03183453
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Monica Triviño Mosquera

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorders
Keywords
Confabulations, Neuropsychological rehabilitation, Memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuropsychological treatment
Arm Type
Experimental
Arm Description
The tested treatment is a combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
Arm Title
Non-confabulators control group
Arm Type
No Intervention
Arm Description
Non-confabulators (brain injured patients but without confabulations) in this control group only performed the pre- and post-measurements without treatment.
Arm Title
Healthy control group
Arm Type
No Intervention
Arm Description
Healthy participants in this control group only performed the pre- and post-measurements without treatment.
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological treatment
Other Intervention Name(s)
Confabulations treatment
Intervention Description
Participants had to learn some brief material (words, faces, pictures, news), after which they were asked for an immediate and a delayed recall. After both recalls, participants were confronted with feedback about correct responses, non-responses and errors (i.e., confabulations and errors of attribution). This type of feedback worked on: 1) selective attention during the learning phase, training patients to focus on the relevant details of the stimuli; 2) monitoring processes during the retrieval phase, reinforcing the strategic search and training patients to inhibit traces that were irrelevant; and 3) memory control processes after the retrieval phase. The treatment consisted of 9 sessions and lasted for 3 weeks and the participants performed a baseline before and after treatment.
Primary Outcome Measure Information:
Title
Change in the number of Confabulations
Description
The confabulations recorded were 1) guessed answers, 2) confusions in time and space, 3) a mixture of two or more stimuli presented, and 4) devised or bizarre responses. Scores ranged from 0 (no confabulations) to unlimited number of them (because devised or bizarre responses were recorded) and consisted of the sum of all the confabulations produced during the 3 sessions.
Time Frame
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).
Title
Change in the number of correct responses
Description
Scores ranged from 0 (no correct answers) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).
Time Frame
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).
Title
Change in the number of non-responses
Description
Scores ranged from 0 (no non-responses) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).
Time Frame
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 Outcome Measure Information:
Title
Change in the number of errors in source attribution
Description
After the recall of the material, patients were also asked to remember which modality corresponded to each recall (i.e., seen, heard or imagined), and who had presented the material during the learning session (i.e., the therapist or themselves). Scores ranged from 0 (if all answers were non-responses) to unlimited number (depending on number of confabulations produced by patients).
Time Frame
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Triviño, PhD
Organizational Affiliation
San Rafael University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Rafael University Hospital
City
Granada
ZIP/Postal Code
18001
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
16638795
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.
Results Reference
background
PubMed Identifier
28257420
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.
Results Reference
background
Citation
Schnider A. The confabulating mind. How the brain creates reality. Oxford: Oxford University Press; 2008
Results Reference
background
PubMed Identifier
22781813
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.
Results Reference
background
PubMed Identifier
19150516
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.
Results Reference
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Neuropsychological Rehabilitation of Spontaneous Confabulation: a Replica Study

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