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Completed

NCT Number: NCT02069002

Comparing Interventions for Indoor Air -Related Functional Symptoms

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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Key information

Age range

25 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Finnish Institute of Occupational Health (Finland)

Helsinki, Uusimaa, 00250, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive-Behavioral Therapy (CBT)

Behavioral

Applied relaxation group therapy

Behavioral

Information session (psychoeducation)

Behavioral

Primary outcomes

  1. 15D - instrument

    Time frame: baseline, 3, 6 and 12 months from the baseline

    The health-related quality of life (HRQoL) instrument (Sintonen, 2001)

Secondary outcomes

  1. • Generalized Anxiety Disorder (GAD-7)

    Time frame: baseline, 3, 6 and 12 months from the baseline

    Self-report measure that assesses anxiety symptoms

  2. Insomnia Severity Index (ISI)

    Time frame: baseline, 3, 6 and 12 months from the baseline

    Self-report measure that assesses insomnia severity

  3. The Symptom checkList-90 (SCL-90)

    Time frame: baseline, 6 and 12 months from the baseline

    Self-report measure that assesses general psychological and somatic symptoms and severity

  4. The Patient Health Questionnaire (PHQ-9)

    Time frame: baseline, 3, 6 and 12 months from the baseline

    Self-report measure that assesses depressive symptoms

  5. Visual Analogue Scale (VAS)

    Time frame: baseline, 3, 6 and 12 months from the baseline

    Self-report measure that assesses respiratory symptom severity

  6. The Acceptance and Action Questionnaire-2 (AAQ-2)

    Time frame: baseline, 3, 6 and 12 months from the baseline

    Self-report measure focuses on experiential avoidance and psychological inflexibility

  7. Illness Worry Scale (IWS)

    Time frame: baseline, 3, 6 and 12 months from the baseline

    Self-report measure that focuses on illness worries and attitudes towards illness

  8. Penn State Worry Questionnaire (PSWQ)

    Time frame: baseline, 3, 6 and 12 months from the baseline

    Self-report measure that focuses on mourning and continuous worrying toughs

  9. Need for Recovery (NRF)

    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

  10. Strategy and Attribution Questionnaire (SAQ)

    Time frame: baseline, 6 and 12 months from the baseline

    Self-report measure focuses on personal attribute strategies.

  11. Self-assessed work ability

    Time frame: baseline, 3, 6 and 12 months from the baseline

    Self-assessed work ability (on a scale 0-10) (Tuomi & al. 1998)

Other outcomes

  1. Working Alliance Inventory (WAI)

    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

  2. Sense of coherence Group (SOC-G-20)

    Time frame: after the first, fourth and the last session of the grouptherapy

    For the group therapy patients to evaluate the groups therapeutic alliance.

  3. Satisfaction of the treatment

    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.

Sponsors and collaborators

Lead sponsor

Finnish Institute of Occupational Health

Other

Collaborators

  • City of Helsinki
  • Finnish Work Environment Fund
  • Mehiläinen Oy healthcare service company (Finland)
  • Terveystalo healthcare service company (Finland)
  • The Occupational Health Centre of the city of Espoo
  • The Occupational Health Centre of the city of Vantaa
  • The Social Insurance Institution of Finland

Registry information

Official study title

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

Acronym: TOSI

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 21, 2014
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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