Memory Disorders
Conditions
Keywords
Confabulations, Neuropsychological rehabilitation, Memory
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.
Interventions
BEHAVIORALNeuropsychological treatment
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.
Sponsors
Monica Triviño Mosquera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 86 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Confabulations | 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). |
| Number of Correct Responses | 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). |
| Number of Non-responses | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Countries
Spain
Participant flow
Recruitment details
Patients were recruited during the period between April 2013 and April 2015 at the San Rafael Hospital where they were admitted for rehabilitation after acquired brain injury.
Pre-assignment details
Due to the absence of confabulations in the Dalla Barba interview two participants were excluded. Another two participants were excluded because a deficit in alertness.
Participants by arm
| Arm | Count |
|---|---|
| Neuropsychological Treatment Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits. | 10 |
| No Treatment Patients in the control group only performed the baselines. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Neuropsychological Treatment | No Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 7 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Continuous | 63.9 years STANDARD_DEVIATION 14.3 | 68.1 years STANDARD_DEVIATION 11.2 | 66.0 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Spain | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 7 / 10 |
Outcome results
Primary
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).
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
Population: We used preliminary data from the first 5 patients using the G\*Power software to calculate the sample size. From them, to detect differences through a Student t-test considering the significance level is 5%, the sample size was estimated in 7 subjects per group with an alpha of 0.95. We expanded to 10 to ensure greater power.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neuropsychological Treatment | Number of Confabulations | Pre baseline | 30.0 Confabulations | Standard Deviation 9.9 |
| Neuropsychological Treatment | Number of Confabulations | Post baseline | 8.1 Confabulations | Standard Deviation 4.2 |
| No Treatment | Number of Confabulations | Post baseline | 35.5 Confabulations | Standard Deviation 11.3 |
| No Treatment | Number of Confabulations | Pre baseline | 29.9 Confabulations | Standard Deviation 13.8 |
Primary
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).
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
Population: Minimum number for comparison of means calculated with G\*Power software (see Analysis Population Description of previous outcome measure data, i.e., confabulations).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neuropsychological Treatment | Number of Correct Responses | Pre baseline | 22.0 Correct responses | Standard Deviation 13.6 |
| Neuropsychological Treatment | Number of Correct Responses | Post baseline | 42.6 Correct responses | Standard Deviation 18.7 |
| No Treatment | Number of Correct Responses | Pre baseline | 20.9 Correct responses | Standard Deviation 10.6 |
| No Treatment | Number of Correct Responses | Post baseline | 22.0 Correct responses | Standard Deviation 8.9 |
Primary
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).
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
Population: Minimum number for comparison of means calculated with G\*Power software (see Analysis Population Description of the first outcome measure data, i.e., confabulations).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neuropsychological Treatment | Number of Non-responses | Pre baseline | 26.3 Non-responses | Standard Deviation 15.8 |
| Neuropsychological Treatment | Number of Non-responses | Post baseline | 22.3 Non-responses | Standard Deviation 17.5 |
| No Treatment | Number of Non-responses | Pre baseline | 29.5 Non-responses | Standard Deviation 11.8 |
| No Treatment | Number of Non-responses | Post baseline | 19.2 Non-responses | Standard Deviation 8.8 |
Secondary
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). 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).
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
Population: Minimum number for comparison of means calculated with G\*Power software (see Analysis Population Description of the first outcome measure data, i.e., confabulations).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neuropsychological Treatment | Number of Errors in Source Attribution | Pre baseline | 25.1 Errors in source attribution | Standard Deviation 6.1 |
| Neuropsychological Treatment | Number of Errors in Source Attribution | Post baseline | 12.2 Errors in source attribution | Standard Deviation 7 |
| No Treatment | Number of Errors in Source Attribution | Pre baseline | 25.7 Errors in source attribution | Standard Deviation 12.5 |
| No Treatment | Number of Errors in Source Attribution | Post baseline | 30.2 Errors in source attribution | Standard Deviation 11.6 |