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Completed

NCT Number: NCT02540772

Neuropsychological Rehabilitation of Spontaneous Confabulation

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.

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Key information

Conditions

Memory Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Rafael University Hospital

Granada, 18001, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 alcohol or drug abuse.
  • Psychiatric antecedents.

Treatment and study plan

Neuropsychological treatment

Behavioral

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.

Other names: Confabulations treatment

Primary outcomes

  1. Number of Confabulations

    Time frame: 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

    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).

  2. Number of Correct Responses

    Time frame: 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

    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).

  3. Number of Non-responses

    Time frame: 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

    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).

Secondary outcomes

  1. Number of Errors in Source Attribution

    Time frame: 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

    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).

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

Sponsors and collaborators

Lead sponsor

Monica Triviño Mosquera

Other

Registry information

Official study title

Study of the Neuroanatomical Circuits, Predictors and Prognostic Factors of Spontaneous Confabulation: Designing an Assessment and Rehabilitation Program

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2015
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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