Finnish Institute of Occupational Health (Finland)
Helsinki, Uusimaa, 00250, Finland
NCT Number: NCT02069002
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.
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Notify Me25 year–58 year
All sexes
Interventional
Not applicable
Helsinki, Uusimaa, 00250, Finland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: baseline, 3, 6 and 12 months from the baseline
The health-related quality of life (HRQoL) instrument (Sintonen, 2001)
Time frame: baseline, 3, 6 and 12 months from the baseline
Self-report measure that assesses anxiety symptoms
Time frame: baseline, 3, 6 and 12 months from the baseline
Self-report measure that assesses insomnia severity
Time frame: baseline, 6 and 12 months from the baseline
Self-report measure that assesses general psychological and somatic symptoms and severity
Time frame: baseline, 3, 6 and 12 months from the baseline
Self-report measure that assesses depressive symptoms
Time frame: baseline, 3, 6 and 12 months from the baseline
Self-report measure that assesses respiratory symptom severity
Time frame: baseline, 3, 6 and 12 months from the baseline
Self-report measure focuses on experiential avoidance and psychological inflexibility
Time frame: baseline, 3, 6 and 12 months from the baseline
Self-report measure that focuses on illness worries and attitudes towards illness
Time frame: baseline, 3, 6 and 12 months from the baseline
Self-report measure that focuses on mourning and continuous worrying toughs
Time frame: baseline, 3, 6 and 12 months from the baseline
Self-report measure that focuses on time needed on the recovery after work day
Time frame: baseline, 6 and 12 months from the baseline
Self-report measure focuses on personal attribute strategies.
Time frame: baseline, 3, 6 and 12 months from the baseline
Self-assessed work ability (on a scale 0-10) (Tuomi & al. 1998)
Time frame: after the first, fifth and the last session of the CBT
Self-report measure that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond; for therapists and the patient of the individual cognitive-behavior therapy
Time frame: after the first, fourth and the last session of the grouptherapy
For the group therapy patients to evaluate the groups therapeutic alliance.
Time frame: 3, 6 and 12 months from the baseline
Questionnaire for the intervention groups patients to evaluate the satisfaction of the treatment and its efficacy.
Finnish Institute of Occupational Health
Other
Psychosocial Interventions for Indoor Air -Related Functional Symptoms - Randomized Controlled Trial (RCT)
Acronym: TOSI
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