Comparing Interventions for Indoor Air -Related Functional Symptoms

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02069002
• Date of registration: 20/02/2014
• Prospective Registration: No
• Primary sponsor: Finnish Institute of Occupational Health
• Public title: Comparing Interventions for Indoor Air -Related Functional Symptoms TOSI
• Scientific title: Psychosocial Interventions for Indoor Air -Related Functional Symptoms - Randomized Controlled Trial (RCT)
• Date of first enrolment: February 2014
• Target sample size: 75
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02069002
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Finland

Contacts

• Name: Tiina M. Paunio, MD, PhD
• Affiliation: Finnish Institute of Occupational Health and University of Helsinki

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Self-assessed work ability not more than 7 (on a scale 0-10, compared to lifetime
best) (removed, see below)

2. Employed minimum three (3) or more years

3. Symptoms related to work environment indoor air (non-industrial workplaces)

4. Respiratory symptoms related to indoor air

5. And symptoms involve more than one other organ system

6. Symptoms onset maximum three years before the study

7. Symptoms are recurrent

8. Symptoms appear more than one (1) environment or continue after repairs environmental
exposure(s)

9. No single widely acceptable test of organ system function can explain the symptoms
(symptoms are medically unexplained)

10. Minimum of one sick leave due to indoor air symptoms during the preceding half year

11. Fluent Finnish (write/read/speak) (due the interventions)

Exclusion Criteria:

1. six (6) months or more sick leave sick leaves due to indoor air symptoms during the
preceding two years and currently unable to work

2. Planned changes in the work (for example retirement, study free period, pregnancy
etc.) during the study

3. An acute, untreated medical disorder or illnesses:

1. Somatic disease that explains the symptoms

2. An acute, untreated mental disorder (depression, bipolar disorder, psychotic
disorders, obsessive-compulsive disorder, eating disorders, personality
disorders)

3. Abuse of narcotics or alcohol or (non-prescribed) medicine

4. Developmental disorders

4. Psychotherapy (current or has ended preceding two years)

5. No inform consent

6. 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.



Age minimum: 25 Years
Age maximum: 58 Years
Gender: All

Health Condition(s) or Problem(s) studied

Environmental Illness

Functional Symptoms

Intervention(s)

Behavioral: Information session (psychoeducation)

Behavioral: Applied relaxation group therapy

Behavioral: Cognitive-Behavioral Therapy (CBT)

Primary Outcome(s)

15D - instrument [Time Frame: baseline, 3, 6 and 12 months from the baseline]

Secondary Outcome(s)

• Generalized Anxiety Disorder (GAD-7) [Time Frame: baseline, 3, 6 and 12 months from the baseline]

Penn State Worry Questionnaire (PSWQ) [Time Frame: baseline, 3, 6 and 12 months from the baseline]

Illness Worry Scale (IWS) [Time Frame: baseline, 3, 6 and 12 months from the baseline]

The Symptom checkList-90 (SCL-90) [Time Frame: baseline, 6 and 12 months from the baseline]

Self-assessed work ability [Time Frame: baseline, 3, 6 and 12 months from the baseline]

The Patient Health Questionnaire (PHQ-9) [Time Frame: baseline, 3, 6 and 12 months from the baseline]

Visual Analogue Scale (VAS) [Time Frame: baseline, 3, 6 and 12 months from the baseline]

Need for Recovery (NRF) [Time Frame: baseline, 3, 6 and 12 months from the baseline]

The Acceptance and Action Questionnaire-2 (AAQ-2) [Time Frame: baseline, 3, 6 and 12 months from the baseline]

Insomnia Severity Index (ISI) [Time Frame: baseline, 3, 6 and 12 months from the baseline]

Strategy and Attribution Questionnaire (SAQ) [Time Frame: baseline, 6 and 12 months from the baseline]

Secondary ID(s)

TSR113076

TTL338270202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Occupational Health Centre of the city of Espoo

The Social Insurance Institution of Finland

City of Helsinki

Terveystalo healthcare service company (Finland)

The Occupational Health Centre of the city of Vantaa

Finnish Work Environment Fund

Mehiläinen Oy healthcare service company (Finland)