A Pilot Trial on the Effect of Mindfulness-based Cognitive Therapy Versus "Treatment as Usual" for Individuals With Multiple Chemical Sensitivities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Symptom Checklist- 92 (SCL-92)
研究概览
简要总结
OBJECTIVES
The objective is to evaluate the effect of an 8-week mindfulness-based cognitive therapy (MBCT) programme on psychological - and somatic symptoms, and illness perceptions in individuals with self- reported multiple chemical sensitivities.
PARTICIPANTS
Participants will be recruited among respondents to a survey on the consequences of self-reported symptoms related to inhalation of airborne chemicals conducted by the Danish Research Centre for Chemical Sensitivities.
DESIGN
The pilot trial is designed as a randomized trial on the effect of MBCT versus treatment as usual.
INTERVENTION
The MBCT programme includes 2½ hours of group training at the Psychiatric Centre, Rigshospitalet once a week for 8 weeks. Furthermore participants are encouraged to practice at home for up to 45 min per day, 6 days a week during the entire course.
OUTCOME MEASURES
Effect of MBCT will be estimated from individual scores on psychometric scales
详细描述
BACKGROUND
Multiple chemical sensitivities is a collective term used to describe illness from exposure to common environ-mental agents. A recent Danish population-based cross sectional study reported that 27% of the respondents reported various symptoms from exposure to common environmental agents. In 19% of the respondents symptoms had led to behavioral changes and in 3.3% of the respondents to adjustments in either social life or occupational conditions, and in 0.5% to adjustments in both social life and occupational conditions. Multiple chemical sensitivities is not acknowledged as a clinical diagnose in Denmark and the Danish Healthcare System has no clinical guidelines for management of people who report this type of illness.
OBJECTIVES
To evaluate the effect of an 8-week mindfulness-based cognitive therapy (MBCT) programme on psychological - and somatic symptoms, and illness perceptions in individuals with self- reported multiple chemical sensitivities.
PARTICIPANTS
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years,
- •Currently living in Zealand,
- •Self - reported adjustments of social life and/or occupational conditions due to symptoms related to inhalation of airborne chemicals,
- •Registered at the Danish Research Centre for Chemical Sensitivities because of self-reported symptoms attributed to common chemical scents,
- •Consulted the Al-lergy Clinic,
- •Rigshospitalet between 1990 and 2006 because of self-reported symptoms related to exposures to common environmental agents,
- •Informed consent
排除标准
- •Severe depression
- •Psychotic disorders
- •Medical treatment with antianxiety agents and antidepressants
- •Alcohol - or drug abuse
- •Previous participation in a MBCT programme
- •Lack of informed consent
结局指标
主要结局
Symptom Checklist- 92 (SCL-92)
时间窗: Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course
次要结局
- The Brief Illness Perception Questionnaire (Brief IPQ)(Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course)
- Perceived Stress Scale (PSS-10)(Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course)
- The subjective health complaints (SHC) inventory(Baseline, four- and eight weeks after start of MBCT course, 3 months after ending MBCT course)