Psychosocial Interventions for Indoor Air -Related Functional Symptoms - Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- 15D - instrument
研究概览
简要总结
The aim of the current study is to compare the effictiveness of three different psychosocial therapies for treating functional disorders caused by indoor air problems.
详细描述
Indoor air -related respiratory and other multiple organ symptoms are common in work environments in Finland. Symptoms effect on well-being and quality of life and may lead to impaired social and cognitive functioning and decreased work ability. All indoor air -related conditions are not explained by underlying physical factors and remain medically unexplained. Functional disorders are conditions where patients complain of multiple medically unexplained physical symptoms or physical problems don´t correlate with symptom severity. Indoor air -related symptoms and functional disorders are strongly associated to each other but there are no well-established diagnostic criteria for the condition . So far, there is no available treatment program to the indoor air -related symptoms to offer in primary or occupational health care services in Finland.
In randomized controlled trials, cognitive behavioral treatment has shown to be effective for patients suffering from functional disorders. In addition, a relaxation technique entitled as applied relaxation (Tuomisto & al, 1996) have shown to been shown to been effective to treat different kind of functional problems.
There are no published trials on treatment for individuals of indoor air related symptomatology. The present study is designed as a pragmatic trial to investigate the effect of three different treatment programs as compared to treatment as usual (TAU) for indoor air- related problems in order to improve the (1) work capacity and (2) well-being. A secondary aim of the study is to identify psychological factors affecting the patients' response to the treatment.
The patients are recruited from occupational health care services to establish and to evaluate the efficacy and usability of the treatment procedures. Participants will first undergo baseline assessment including medical examination of the respiratory symptoms. Then they are randomized to one of the study groups: TAU or one of the intervention groups. All study patients receive TAU at occupational health care services for their medical problems during the study. Patients randomized to the study groups receive also the intervention with TAU.
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
- 25 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-assessed work ability not more than 7 (on a scale 0-10, compared to lifetime best) (removed, see below)
- •Employed minimum three (3) or more years
- •Symptoms related to work environment indoor air (non-industrial workplaces)
- •Respiratory symptoms related to indoor air
- •And symptoms involve more than one other organ system
- •Symptoms onset maximum three years before the study
- •Symptoms are recurrent
- •Symptoms appear more than one (1) environment or continue after repairs environmental exposure(s)
- •No single widely acceptable test of organ system function can explain the symptoms (symptoms are medically unexplained)
- •Minimum of one sick leave due to indoor air symptoms during the preceding half year
- •Fluent Finnish (write/read/speak) (due the interventions)
排除标准
- •six (6) months or more sick leave sick leaves due to indoor air symptoms during the preceding two years and currently unable to work
- •Planned changes in the work (for example retirement, study free period, pregnancy etc.) during the study
- •An acute, untreated medical disorder or illnesses:
- •Somatic disease that explains the symptoms
- •An acute, untreated mental disorder (depression, bipolar disorder, psychotic disorders, obsessive-compulsive disorder, eating disorders, personality disorders)
- •Abuse of narcotics or alcohol or (non-prescribed) medicine
- •Developmental disorders
- •Psychotherapy (current or has ended preceding two years)
- •No inform consent
- •Other: Patient refusal; not actively participating working life (retired or unemployed)
- •Based on a steering group´s advice and agreement (10.10.2014), inclusion criteria (Self-assessed work ability not more than 7, on a scale 0-10, compared to lifetime best) was removed. Recruitment continues without this question as an inclusion criteria.
研究组 & 干预措施
Cognitive-Behavioral Therapy (CBT)
There will be ten (10) manualized session, fist 90 minutes and nine (9) 45-minute individual sessions conducted at weekly intervals, last two sessions 2 weeks intervals. One booster session will be conducted three months after the treatment. Sessions include psychoeducation about indoor air related symptoms and personal health behavior factors integrated on patients individual symptomatology, cognitive restructuring, behavioral experiments of patients health promoting behavior, imagery rescripting and relapse prevention.
Intervention: Behavioral: Psychotherapy (CBT)
干预措施: Cognitive-Behavioral Therapy (CBT) (Behavioral)
Applied relaxation group therapy
There will be seven (7) manualized session, first 120 minutes and six (6) 90-minute group sessions conducted at weekly intervals, last two sessions 2 weeks intervals. One booster session will be conducted three months after treatment. Sessions include information about indoor air related symptoms, behavioral training and experiments focusing on applied relaxation technique and relapse prevention.
Intervention: Behavioral: group therapy (ART)
NB: The Applied Relaxation group Therapy won´t be carried out due to slow and prolonged recruiting process (A steering group agreement 4/2015 and the Ethics Committee approval 5/2015 for the change of the study plan).
干预措施: Applied relaxation group therapy (Behavioral)
Information session (psychoeducation)
There will be one (1) manualized 90-minute individual session. The session includes information about indoor air related symptoms and factors affecting individual health behavior.
Intervention: Information session (psychoeducation)
干预措施: Information session (psychoeducation) (Behavioral)
结局指标
主要结局
15D - instrument
时间窗: baseline, 3, 6 and 12 months from the baseline
The health-related quality of life (HRQoL) instrument (Sintonen, 2001)
次要结局
- • Generalized Anxiety Disorder (GAD-7)(baseline, 3, 6 and 12 months from the baseline)
- Insomnia Severity Index (ISI)(baseline, 3, 6 and 12 months from the baseline)
- The Symptom checkList-90 (SCL-90)(baseline, 6 and 12 months from the baseline)
- The Patient Health Questionnaire (PHQ-9)(baseline, 3, 6 and 12 months from the baseline)
- Visual Analogue Scale (VAS)(baseline, 3, 6 and 12 months from the baseline)
- The Acceptance and Action Questionnaire-2 (AAQ-2)(baseline, 3, 6 and 12 months from the baseline)
- Illness Worry Scale (IWS)(baseline, 3, 6 and 12 months from the baseline)
- Penn State Worry Questionnaire (PSWQ)(baseline, 3, 6 and 12 months from the baseline)
- Need for Recovery (NRF)(baseline, 3, 6 and 12 months from the baseline)
- Strategy and Attribution Questionnaire (SAQ)(baseline, 6 and 12 months from the baseline)
- Self-assessed work ability(baseline, 3, 6 and 12 months from the baseline)