NCT02540772

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, the aim of this trial was to design a neuropsychological treatment based on the current theoretical models and test it experimentally in two groups of confabulators: experimental vs. control. 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 baselines were administered. Confabulators in the control group performed the baselines without treatment, and were then offered the treatment after the second baseline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 7, 2016

Completed
Last Updated

March 7, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

August 15, 2015

Results QC Date

September 5, 2015

Last Update Submit

February 9, 2016

Conditions

Memory Disorders

Keywords

ConfabulationsNeuropsychological rehabilitationMemory

Outcome Measures

Primary Outcomes (3)

  • 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 baseline. The values in the table represent the mean of confabulations for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment).

    Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them

  • 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). The values in the table represent the mean of correct responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment).

    Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them

  • 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). The values in the table represent the mean of non-responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment).

    Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them

Secondary Outcomes (1)

  • Number of Errors in Source Attribution

    Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them

Study Arms (2)

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

No treatment

NO INTERVENTION

Patients in the control group only performed the baselines.

Interventions

Neuropsychological treatmentBEHAVIORAL

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 - 86 Years
Sexall
Healthy VolunteersNo
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 alcohol or drug abuse.
  • Psychiatric antecedents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Rafael University Hospital

Granada, Granada, 18001, Spain

Location

Related Publications (8)

  • 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

  • Moscovitch M, Melo B. Strategic retrieval and the frontal lobes: evidence from confabulation and amnesia. Neuropsychologia. 1997 Jul;35(7):1017-34. doi: 10.1016/s0028-3932(97)00028-6.

    PMID: 9226662BACKGROUND

  • 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

  • Dayus B, Van den Broek MD. Treatment of stable delusional confabulations using self-monitoring training. Neuropsychol Rehabil, 2000; 10(4):415-427.

    BACKGROUND

  • Del Grosso Destreri N, Farina E, Calabrese E, Pinardi G, Imbornone E, Mariani C. Frontal impairment and confabulation after herpes simplex encephalitis: A case report. Arch Phys Med Rehabil. 2002 Mar;83(3):423-6. doi: 10.1053/apmr.2002.29646.

    PMID: 11887126BACKGROUND

  • Dalla Barba G, Decaix C. "Do you remember what you did on March 13, 1985?" A case study of confabulatory hypermnesia. Cortex. 2009 May;45(5):566-74. doi: 10.1016/j.cortex.2008.03.009. Epub 2008 Jun 5.

    PMID: 18621364BACKGROUND

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Monica Triviño Mosquera
Organization
San Rafael University Hospital
monica.trivino@sjd.es
34958275700

Study Officials

  • Monica Triviño, PhD

    San Rafael University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

August 15, 2015

First Posted

September 4, 2015

Study Start

April 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

March 7, 2016

Results First Posted

March 7, 2016

Record last verified: 2016-02

Locations

ES(1)