Comparing Interventions for Indoor Air -Related Functional Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Psychosocial Interventions for Indoor Air -Related Functional Symptoms - Randomized Controlled Trial (RCT)

Conditions
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Environmental Illness, Functional Symptoms

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Therapy (CBT)
* Behavioral: Applied relaxation group therapy
* Behavioral: Information session (psychoeducation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 58 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-Behavioral Therapy (CBT)<br>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) | Behavioral: Cognitive-Behavioral Therapy (CBT)<br> <br> |
| Experimental: Applied relaxation group therapy<br>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). | Behavioral: Applied relaxation group therapy<br> <br> |
| Experimental: Information session (psychoeducation)<br>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) | Behavioral: Information session (psychoeducation)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15D - instrument | The health-related quality of life (HRQoL) instrument (Sintonen, 2001) | baseline, 3, 6 and 12 months from the baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Generalized Anxiety Disorder (GAD-7) | Self-report measure that assesses anxiety symptoms | baseline, 3, 6 and 12 months from the baseline | 
| Insomnia Severity Index (ISI) | Self-report measure that assesses insomnia severity | baseline, 3, 6 and 12 months from the baseline | 
| The Symptom checkList-90 (SCL-90) | Self-report measure that assesses general psychological and somatic symptoms and severity | baseline, 6 and 12 months from the baseline | 
| The Patient Health Questionnaire (PHQ-9) | Self-report measure that assesses depressive symptoms | baseline, 3, 6 and 12 months from the baseline | 
| Visual Analogue Scale (VAS) | Self-report measure that assesses respiratory symptom severity | baseline, 3, 6 and 12 months from the baseline | 
| The Acceptance and Action Questionnaire-2 (AAQ-2) | Self-report measure focuses on experiential avoidance and psychological inflexibility | baseline, 3, 6 and 12 months from the baseline | 
| Illness Worry Scale (IWS) | Self-report measure that focuses on illness worries and attitudes towards illness | baseline, 3, 6 and 12 months from the baseline | 
| Penn State Worry Questionnaire (PSWQ) | Self-report measure that focuses on mourning and continuous worrying toughs | baseline, 3, 6 and 12 months from the baseline | 
| Need for Recovery (NRF) | Self-report measure that focuses on time needed on the recovery after work day | baseline, 3, 6 and 12 months from the baseline | 
| Strategy and Attribution Questionnaire (SAQ) | Self-report measure focuses on personal attribute strategies. | baseline, 6 and 12 months from the baseline | 
| Self-assessed work ability | Self-assessed work ability (on a scale 0-10) (Tuomi & al. 1998) | baseline, 3, 6 and 12 months from the baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indoor Air, Medically unexplained symptoms, Randomized controlled trial, Cognitive-Behavioral Therapy, Applied relaxation