Development and Validation of an Intervention Targeting Motivational Negative Symptoms: Switch Protocol 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Lille Apathy Rating Scale (patient version) (LARS-p)
研究概览
简要总结
This study aims to investigate the effects of the Switch intervention on motivation and associated processes and explore the dynamics between the processes.
A single case approach is followed, with a pre-post and follow-up assessment design, and continuous ambulatory assessments (experience sampling method (ESM) and step count).
详细描述
Motivational negative symptoms hinder quality of life and daily functioning of individuals with schizophrenia spectrum, bipolar and major depressive disorders.
A recently developed intervention, Switch, has shown promising effects on negative symptoms and functional outcomes. Switch is based on a model that identifies various cognitive, behavioural and emotional processes related to motivation and goal-directed behaviours: pleasure anticipation, value-effort-probability computation, (dys)functional attitudes (e.g., discouraging thoughts, self-efficacy), planning, initiation, in-the-moment enjoyment, reminiscence. The intervention combines a person-centred and recovery approach with cognitive, behavioural and 3rd wave techniques to tackle the obstacles related to motivation and goal-directed behaviours (i.e., targetting the various cognitive, behavioural and emotional processes listed above). Thus, an important part of the intervention focuses on the person's strengths, needs, goals and values. Furthermore, various strategies (e.g., cognitive defusion, pleasure anticipation, problem solving, reminiscence) are used to encourage engagement in meaningful personal goals and values.
The Switch intervention is provided either in individual (one-hour sessions), or in a group setting (two-hour sessions), twice a week for around two months.
There are three types of evaluation: traditional assessment scales of motivational deficits, apathy, quality of life and daily functioning (pre, post and follow-up at 3 months); ambulatory assessment including ESM (i.e., daily questionnaires); actigraphy (step count).
The aims of this study is to evaluate the efficacy of Switch in two different settings (i.e., individual sessions and a group programme) on motivation/apathy and functional outcomes/quality of life. Furthermore, we wish to explore the effects of Switch on process related to motivation and goal-directed behaviours (e.g., pleasure anticipation, reminiscence, defeatist beliefs, activities' meaningfulness) and on activity (i.e., step count). Finally, we wish to evaluate the dynamics between the different cognitive, behavioural and emotional processes related to motivation and goal-directed behaviours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
A blinding procedure was used for the evaluation of the Brief Negative Symptom Scale: interviews were recorded and each video or sound recording was evaluated at the end of the study by one (or two) independent evaluator who was unaware of the recordings' assessment time.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual-V (DSM-V) criteria for schizophrenia, schizoaffective, bipolar or major depressive disorder (American Psychiatric Association, 2013).
- •Good understanding of French.
排除标准
- •Presenting an unstable clinical picture;
- •Evidence of a significant change in medication within one month prior to baseline assessment;
- •Having a history of severe brain trauma or epilepsy;
- •Comorbid intellectual disability;
- •Moderate or severe substance use disorder other than tobacco (according to the DSM-V; i.e., showing 4 or more symptoms).
结局指标
主要结局
Lille Apathy Rating Scale (patient version) (LARS-p)
时间窗: 2 months (post-intervention)
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 (\[-36; -22\] = absence of apathy; \[-21; -17\] = tendency towards apathy; \[-16; -10\] = moderate apathy; \[-9; 36\] = severe apathy).
Lille Apathy Rating Scale (informant version) (LARS-i)
时间窗: 6 months (follow-up)
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 (\[-36; -22\] = absence of apathy; \[-21; -17\] = tendency towards apathy; \[-16; -10\] = moderate apathy; \[-9; 36\] = severe apathy).
Functional Remission of General Schizophrenia (FROGS)
时间窗: 6 months (follow-up)
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.
Brief Negative Symptom Scale (BNSS)
时间窗: 6 months (follow-up)
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Schizophrenia - Quality of Life questionnaire
时间窗: 6 months (follow-up)
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
次要结局
- Experience Sampling Method(Follow-up (14 days): 5 triggers/day)
- Step count(Follow-up (14 days): 5 triggers/day)
研究者
Thonon Bénédicte
Principal investigator
University of Liege