Replica Study of a Neuropsychological Treatment for Patients Who Show Spontaneous Confabulation After Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in the number of correct responses
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •The presence of impairment in alertness.
- •Dementia.
- •Acute confusional state.
- •A history of drug abuse.
- •Psychiatric antecedents.
研究组 & 干预措施
Neuropsychological treatment
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.
干预措施: Neuropsychological treatment (Behavioral)
Non-confabulators control group
Non-confabulators (brain injured patients but without confabulations) in this control group only performed the pre- and post-measurements without treatment.
Healthy control group
Healthy participants in this control group only performed the pre- and post-measurements without treatment.
结局指标
主要结局
Change in the number of correct responses
时间窗: 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).
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 Confabulations
时间窗: 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).
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 non-responses
时间窗: 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).
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).
次要结局
- 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).)
研究者
Monica Triviño Mosquera
Psychology PhD
San Rafael University Hospital, Granada, Spain