Improving Cognitive and Emotional Processing in Older (Psychiatric) Patients: the Transdiagnostic Effectiveness of the Ronnie Gardiner Method (RGM).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Core EFs (i.e. motor/response inhibition, cognitive flexibility and working memory) using four subtests of the Cambridge Neuropsychological Test Automated Battery (CANTAB® [Cognitive assessment software]).
研究概览
简要总结
The investigators want to investigate the feasibility and transdiagnostic effectiveness of the Ronnie Gardiner Method (RGM) in a sample of Flemish psychogeriatric residential patients (≥60 years old) admitted to the Psychiatric Clinic of Alexianen Zorggroep Tienen. No control group will be used in this study, as every patient in the clinic is entitled to receive treatment. The investigators expect to observe significant improvements in the core executive functions (core EFs) by RGM participation. The investigators expect that the more sessions participants follow, the larger the effects will be. Given the strong connection between executive functions and emotion regulation, the investigators anticipate that strengthening the core EFs will in turn contribute to better emotion regulation. More specifically, the mediating role of core EFs in the relationship between the number of RGM sessions attended and improvement in emotion regulation is investigated. Given RGMs previously reported effects on quality of life, the investigators also expect to observe improved well-being. Additionally, the investigators want to examine to what extent positive experiences with RGM and temperament based personality types influence the effectiveness of the RGM training.
The RGM training will be organised twice a week for a period of 12 weeks. The training sessions will be provided by trained RGM-practitioners in the Psychiatric Clinic of the Alexianen Zorggroep Tienen. Each session will last at least 45 minutes. Core EFs, emotion regulation and well-being are evaluated pre-, mid- and post-RGM (at 6-week intervals) using a number of relevant instruments (i.e. questionnaires and neuropsychological tests). At baseline, the information and consent forms will be delivered to the patient and exclusion criteria will be checked using the MMSE and the patient file. Experiences with RGM training will be evaluated midway and post-intervention by means of a brief questionnaire developed by the research team. Personality type questionnaires (The Behavioural Inhibition System (BIS)/Behavioural Activation System (BAS) scales and the Effortful Control (EC) scale), which allow us to study whether a particular temperament based personality type is predictive of RGMs success, are routinely administered in the psychiatric clinic upon admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Psychogeriatric inpatients aged 60+
排除标准
- •Checking for moderate to severe cognitive impairments (exclusion criterion) using the Mini-Mental State Examination (MMSE; Folstein, Folstein, & McHugh, 1975; Dutch version: Kok and Verhey, 2002), following exclusion criterion applies: a score of less than 21 on the MMSE (excluding dementia or other moderate to severe cognitive impairment)
- •Not fluent in Dutch
- •Having undergone surgery and/or chemotherapy in the last three months.
结局指标
主要结局
Change in Core EFs (i.e. motor/response inhibition, cognitive flexibility and working memory) using four subtests of the Cambridge Neuropsychological Test Automated Battery (CANTAB® [Cognitive assessment software]).
时间窗: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training
The four subtests are: (1)Intra-Extra Dimensional Set Shift (Cognitive Flexibility), (2) Spatial Span, (3) Spatial Working Memory and (4) Stop-Signal Task (Inhibition). For the subtest Intra-Extra Dimensional Set Shift (IED), total latency (which is the sum of the response times over all trials) and in addition the total number of errors adjusted (which is the number of incorrect stimulus choices) will be analyzed. Next outcome measure is the Spatial Span Forward Span Length (SSPFSL), which is the longest sequence that the participant can reproduce forward. The Spatial Working Memory Total Errors (SWMTE) is another outcome measure to analyze recall problems. This is a measure of the total number of selections from a box that certainly cannot contain a token. The final outcome measure of the CANTAB is the Stop Signal Task Stop Signal Reaction Time (SSTSSRT), which is the estimated time in which a participant can successfully inhibit their responses 50% of the time.
Change in Emotion Regulation using the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2002)
时间窗: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training
The CERQ was originally developed in Dutch. This self-report questionnaire has 36 items that evaluate the frequency of the use of emotion regulation strategies. The items are divided proportionally among nine emotion regulation strategies based on theory and empirical research: blaming yourself, blaming others, accepting, rumination, relating, catastrophising, focusing on other positive things, focusing on planning and positively reinterpreting. The items are answered on a Likert five-point scale ranging from almost never (1) to almost always (5) (Kraaij \& Garnefski, 2006; Garnefski \& Kraaij, 2006; Garnefski \& Kraaij, 2007; Nowlan et al., 2015). Variations in the total scores of the nine subscales of the CERQ will be examined.
Change in Core EFs (i.e. cognitive inhibition) using the California Older Adult Stroop Test (COAST)
时间窗: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training
The COAST is a modified Stroop Color-Word Test (SCWT) that was developed specifically for older adults by Pachana and colleagues (2004). In the COAST, only three, more easily distinguishable colours (red, yellow and green) and a larger font are used to minimise the risk of errors due to colour confusion or reduced visual acuity. In addition, the number of items in the COAST was reduced (to 50 items) to minimise fatigue. For this study, we are mainly interested in the last subtest. In this subtest, colour words are presented in a different ink colour (e.g. the word GREEN with a red ink colour) and the aim is for the participants to name the ink colour and inhibit the reading automaticity. The interference score, total completion time and total error score on the interference task of the COAST will be analyzed in this study. Thus, both response/motor inhibition (using the CANTAB Stop-Signal Task) and cognitive inhibition (using the COAST) are studied.
Monitor mental well-being using the Dutch version of the 14-item Warwick-Edingburgh Mental Well-Being Scale (WEMWBS)
时间窗: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training
This questionnaire includes 14 (positively worded) items that question mental well-being (Taggart \& Stewart-Brown, 2015; Tennant et al., 2007). The questionnaire is suitable for individuals as young as 13 years old (Taggart \& Stewart-Brown, 2015). Participants are required to answer the items on a five-point scale, ranging from never (1) to always (5), according to their psychological functioning over the past two weeks. The sensitivity to change of the WEMWBS has been well validated (Taggart \& Stewart-Brown, 2015). This is important in intervention studies where pre- and post-scores are compared, which is also the aim in the current study. The research duo Taggart and Stewart-Brown (2015) compared different instruments of mental well-being and concluded that the WEMWBS is preferred (over the WHO-5) in intervention studies. The total score will be analyzed for this study. The higher the total score, the higher the level of mental well-being (Tennant et al., 2007).
次要结局
- Defining the temperament based personality type using the Behavioural Inhibition System (BIS)/Behavioural Activation System (BAS) scale(routinely administrated in the psychiatric clinic upon admission)
- Experiences with RGM-training(after 6 weeks of RGM-training and after 12 weeks of RGM-training)
- Defining the temperament based personality type using the Effortful Control (EC) scale(routinely administrated in the psychiatric clinic upon admission)
研究者
Xenia Brancart
PhD student
Universitair Ziekenhuis Brussel