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Trials / Completed

CompletedNCT02069002

Comparing Interventions for Indoor Air -Related Functional Symptoms

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
75 (actual)
Sponsor
Finnish Institute of Occupational Health · Academic / Other
Sex
All
Age
25 Years – 58 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive-Behavioral Therapy (CBT)
BEHAVIORALApplied relaxation group therapy
BEHAVIORALInformation session (psychoeducation)

Timeline

Start date
2014-02-01
Primary completion
2018-07-29
Completion
2018-07-30
First posted
2014-02-21
Last updated
2018-08-07

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT02069002. Inclusion in this directory is not an endorsement.