Effectiveness of a Schema Therapy on Anxiety in Patients With Multiple Sclerosis .a Randomized Control Study in 106Persian Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- changes Anxiety in patient with MS,Beck Anxiety Inventory (BAI)
研究概览
简要总结
It is a multicentric randomized and controlled study comparing a Scheme therapy program versus local practice in RRMS patients with anxiety. Patients will assist to twenty once-weekly group sessions with a 6-month follow up after the end of the programme. The main criteria is the impact of schema therapy on anxiety evaluated by the questionnaires at the end of the program and at the end of the 6-month follow-up.
详细描述
A parallel arm randomized controlled trial comparing a group receiving Scheme Therapy plus current usual practice versus a group receiving current local practice only. The trial will take place in KASHANI Hospital (in Isfahan).Recruitment of the participants will be identified and recruited by the neurologists of the hospitals who take part in the programme, when they come for a medical examination.
After giving their informed consent, the patients will be entered onto the trial database and randomized to either the schema therapy or control using software allocated The intervention is the schema therapy focuses on the management of anxiety and is based on self-efficacy, self-management . It consists of 20 once-weekly sessions of 90 minutes (with a 15 Min break), with homework activities between the sessions. It is designed for groups of 8 people and will be delivered by two psychologists. The programme is standardized: Power Points presentations support each session and a detailed therapist manual and companion patient workbook accompany the programme.
For the ST group an evaluation will be administered pretest and post-test six months after the end of the schema therapy programme and at the same times for those in the control group. Socio-demographic and medical data, age, sex, level of education, marital status, number of children and professional status; date of diagnosis, disease type, level of disability (EDSS, Kurtzke, 1983) and information on relapses and treatments, are evaluated. The main criteria is the impact of schema therapy on anxiety evaluated by the BAI (beck anxiety inventory ) and level of cortisol at 6 month after the start program . Secondary criteria are: impact on the psychological dimensions assessed by Hospital Anxiety and Depression Scale (HADS), intensity of fatigue assessed by Fatigue Severity Scale (FSS), sleep quality evaluated by the Pittsburgh Sleep Quality Index(PSQI) depression by BDI (beck depression inventory ) and quality of life evaluated by (Multiple sclerosis impact scale) MSIS29.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subject has relapsing remitting MS
- •anxiety (score >26 at the BAI scale)
- •history of psychotic disorders
- •history of cognitive deficiency
- •use anti-depressant in the past 3 months
- •history of relapse in the past 3 month
- •expanded Disability Status Scale score less than 6
- •ability reading and writing Persian
- •Non hospitalized
排除标准
- •history of psychotic disorders
- •history of cognitive deficiency
- •use anti-depressant in the past 3 months
- •history of relapse in the past 3 month
研究组 & 干预措施
control group
no intervention
experimental group
schema therapy
干预措施: schema therapy (Behavioral)
结局指标
主要结局
changes Anxiety in patient with MS,Beck Anxiety Inventory (BAI)
时间窗: Change measures in 0,6,12 month
Beck Anxiety Inventory (BAI),self-reported questionnaire of anxiety,.21-question multiple- choice each answer being scored on a scale value of 0 (not at all) to 3 (severely),Higher total scores indicate more severe anxiety symptoms . score between 0-63
changes in level of cortisol
时间窗: Change measures in 0,6,12 month
cortisol measure by Immunoassay by cortisol saliva ELISA, DiaMetra ( kit),adult morning peak :3-10 ,higher values represent more anxiety
次要结局
- changes in depression,Beck Depression Inventory (BDI)(Change measures in 0,6,12 month)
- changes quality of life.Multiple sclerosis impact scale - 29 items(MSIS29)(Change measures in 0,6,12 month)
- changes in quality of sleep.Pittsburgh Sleep Quality Index (PSQI)(Change measures in 0,6,12 month)
- changes in fatigue.Fatigue Severity Scale (FSS)(Change measures in 0,6,12 month)
研究者
Azam Mansourzadeh
PHD student of university Nanterre-clinical researcher in university ISFAHAN
Paris Nanterre University