Evaluation of a Compensatory Brain Game Supporting Goal Management Training Intervention Targeting Executive Function in Acquired Brain Injury Patients With Depressive and/or Anxiety Symptoms: a Single-case Experimental Design
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B
研究概览
简要总结
The main cognitive complaint in brain-injured patients is often the everyday disorganization caused by Executive Function (EF) deficits. EF deficits are often seen in patients with psychiatric disorders i.e. depression or anxiety. In order to minimize everyday disorganization, effective EF interventions are required. Interventions using compensatory strategies have the potential to enable patients to minimize disabilities, minimize participation problems and to function more independently in daily life. A well-known evidence-based intervention that uses compensatory strategies is Goal Management Training (GMT), a training that has been found to alleviate depressive symptoms in a depressed population. GMT entails learning and applying an algorithm, in which a daily task is subdivided into multiple steps to handle executive difficulties of planning, and problem solving. To adopt the GMT strategy and ensure maximal profitability for patients, they have to learn to use the algorithm in different situations and tasks. Therefore, GMT is comprehensive, time-consuming and thus labour-intensive. Along with this, brain games become increasingly attractive as an (add-on) intervention, most notably in an effort to develop home-based personalized care. Until now, however, the rationale behind brain games is based on what can be considered the restorative approach (i.e. strengthening of executive problems) rather than practicing compensatory strategies, with little or no transfer to improvements in daily life functioning. This study therefore aims to assess the potential of a newly developed Brain Game, based on compensatory strategies, as an add-on to GMT to develop a shortened and partly self-paced GMT intervention. The primary objective of this study is to assess whether the use of a compensatory brain game supported GMT treatment could be of interest in people with EF deficits after ABI that also suffer from depression or anxiety, to improve goal achievement, their executive function performance during goal-related tasks, and their executive performance during an ecological valid shopping task. Also we assess whether psychological symptoms alleviate following the GMT intervention and at 6-weeks follow-up. The study will be a multiple-baseline across individuals single-case experimental design (SCED). The study population consists of brain-injured patients, between 18 and 75 years old that receive in-patient mental neuropsychiatric healthcare. Participants eligible for the study must have EF deficits due to (nonprogressive) Acquired Brain Injury (ABI), minumum time post-onset of 3 months and depressive or anxiety symptoms. EF deficits will be assessed by extensive neuropsychological examination. Participants will be recruited from an inpatient clinic. In the course of one and a half year four participants will be recruited.
详细描述
Not provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The target behavior (i.e. performance on an untrained shopping task) will be measured repeatedly, on a minimum of six occasions in each phase where possible, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria. Repeated measures of target behavior will be assessed via the OxMET-NL task and is scored automatically: no assessor input is required to either save or score the main outcome data. The secondary outcome measure(s) are scored by an outcome assessor who is blind to the order in which the secondary outcome measure(s) were taken.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 75 years
- •Non-progressive acquired brain injury
- •Minimal time post-onset of 3 months
- •Receive inpatient neuropsychiatric care at the time of inclusion
- •Executive deficits (neuropsychological assessment)
- •Reasonable amount of awareness in their deficits, at least to the extent that they are motivated and capable to learn new skills with respect to their executive performance.
排除标准
- •Inability to speak/understand the Dutch language
- •Severe psychiatric disorders such as psychosis, manic episode, severe disruptive behavior
- •Neurodegenerative disorders (i.e. dementia, Huntington, Parkinson
- •Substance abuse (active)
- •Severe cognitive comorbidity (i.e. Korsakov)
- •Unable to look at a computer screen for 15 minutes
- •Unable to operate a keyboard or computer mouse
研究组 & 干预措施
Follow-up period
A follow-up period of six weeks takes place after phase B. During this follow-up period, patients receive no intervention.
No Intervention: Baseline phase (Phase A)
o At the start of the study, all participants are assigned to the baseline phase (phase A). During phase A, patients do not receive interventions related to executive function problems. The start of the intervention phase (phase B) is determined randomly for each participant, given the restriction that phase A should last for at least three weeks (21 days) and at most five weeks (30 days). This means that phase B can start on any day between the 21th and the 30th days, resulting in a total of 10 possible assignments. So, in the first three weeks, all participants are in phase A. The duration of phase A will thus be different for each subject. Phase A acts as a control and is therefore compared with phase B.
Experimental: Intervention phase (Phase B): Goal Management Training
During the intervention phase (phase B), all included participants will have 6 sessions of Goal Management Training (GMT; twice per week) in which two individual chosen IADL-tasks will be subdivided into multiple steps under guidance of a therapist using the GMT method. In addition participants play the compensatory brain game in which they are challenged to apply the learned GMT strategy in an imaginary and safe environment.
干预措施: Compensatory brain game supporting Goal Management Training intervention (Behavioral)
结局指标
主要结局
Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B
时间窗: The target behavior (i.e. performance on the OxMET-NL) will be measured repeatedly, two times a week, for the duration of phase A (3 to 5 weeks) and phase B (36 weeks
The target behavior will be assessed repeatedly, on a minimum of six occasions in phase A and B, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria (Tate et al., 2013). The OxMET-NL task is a computer-tablet based version of the Multiple Errands Test and is scored automatically. The task requires patients to buy six items and to answer two questions. The main outcome measure of the task is accuracy which ranges from -10 to + 10 (higher score is better outcome) based on a score obtained in each shop.
次要结局
- Change in performance on treatment goals as measured with the Goal Attainment Scale (GAS)(pre-intervention, immediately following intervention and at six weeks follow-up)
- Change in strategy use during the performance of trained and untrained IADL tasks(pre-intervention, immediately following intervention and at six weeks follow-up)
- Change in subjective experience of strategy use in daily life(pre-intervention, immediately following intervention and at six weeks follow-up)
- Change in subjectively experienced psychological symptoms such as depressive, anxiety and stress symptoms.(pre-intervention, immediately following intervention and at six weeks follow-up)
- Change on the Visual Analogue Scale (VAS) from phase A to phase B to follow-up(The VAS will be assessed repeatedly, two times a week, for the duration of phase A (3 to 5 weeks), phase B (3 weeks) and follow-up (6 weeks))
- Change in performance on two trained IADL task (treatment goals)(pre-intervention, immediately following intervention and at six weeks follow-up)
- Change in everyday difficulties in activities/participation as measured on the Daily Living Questionnaire (DLQ-R-NL)(pre-intervention, immediately following intervention and at six weeks follow-up)
研究者
Helen Alexandra Anema
Principal Investigator
ProPersona