NCT03183453

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

May 29, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

April 25, 2017

Last Update Submit

May 25, 2018

Conditions

Keywords

ConfabulationsNeuropsychological rehabilitationMemory

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

  • 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).

    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).

  • 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).

    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 (1)

  • Change in the number of errors in source attribution

    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).

Study Arms (3)

Neuropsychological treatment

EXPERIMENTAL

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.

Behavioral: Neuropsychological treatment

Non-confabulators control group

NO INTERVENTION

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

Healthy control group

NO INTERVENTION

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

Interventions

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.

Also known as: Confabulations treatment
Neuropsychological treatment

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Rafael University Hospital

Granada, 18001, Spain

Location

Related Publications (5)

  • 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.

    PMID: 16638795BACKGROUND
  • 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.

    PMID: 28257420BACKGROUND
  • Schnider A. The confabulating mind. How the brain creates reality. Oxford: Oxford University Press; 2008

    BACKGROUND
  • 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.

    PMID: 22781813BACKGROUND
  • 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.

    PMID: 19150516BACKGROUND

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Monica Triviño, PhD

    San Rafael University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Psychology PhD

Study Record Dates

First Submitted

April 25, 2017

First Posted

June 12, 2017

Study Start

July 1, 2015

Primary Completion

September 1, 2017

Study Completion

January 31, 2018

Last Updated

May 29, 2018

Record last verified: 2018-05

Locations