Clinical trial NCT02069002: Comparing Interventions for Indoor Air -Related Functional Symptoms
Official title: Psychosocial Interventions for Indoor Air -Related Functional Symptoms - Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Illness
Functional Symptoms
Keywords: Indoor Air
Medically unexplained symptoms
Randomized controlled trial
Cognitive-Behavioral Therapy
Applied relaxation
Lead sponsor: Finnish Institute of Occupational Health
Sponsor class: OTHER
Collaborators: name: Finnish Work Environment Fund
name: The Social Insurance Institution of Finland
name: The Occupational Health Centre of the city of Espoo
name: Terveystalo healthcare service company (Finland)
name: Mehiläinen Oy healthcare service company (Finland)
name: The Occupational Health Centre of the city of Vantaa
name: City of Helsinki
First posted: 2014-02-21
Enrollment: 75
Sex: ALL
Minimum age (years): 25
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: 15D - instrument
timeFrame: baseline, 3, 6 and 12 months from the baseline
Secondary outcomes:
measure: • Generalized Anxiety Disorder (GAD-7)
timeFrame: baseline, 3, 6 and 12 months from the baseline
measure: Insomnia Severity Index (ISI)
timeFrame: baseline, 3, 6 and 12 months from the baseline
measure: The Symptom checkList-90 (SCL-90)
timeFrame: baseline, 6 and 12 months from the baseline
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, 3, 6 and 12 months from the baseline
measure: Visual Analogue Scale (VAS)
timeFrame: baseline, 3, 6 and 12 months from the baseline
measure: The Acceptance and Action Questionnaire-2 (AAQ-2)
timeFrame: baseline, 3, 6 and 12 months from the baseline
measure: Illness Worry Scale (IWS)
timeFrame: baseline, 3, 6 and 12 months from the baseline
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: baseline, 3, 6 and 12 months from the baseline
measure: Need for Recovery (NRF)
timeFrame: baseline, 3, 6 and 12 months from the baseline
measure: Strategy and Attribution Questionnaire (SAQ)
timeFrame: baseline, 6 and 12 months from the baseline
measure: Self-assessed work ability
timeFrame: baseline, 3, 6 and 12 months from the baseline
Other outcomes:
measure: Working Alliance Inventory (WAI)
timeFrame: after the first, fifth and the last session of the CBT
measure: Sense of coherence Group (SOC-G-20)
timeFrame: after the first, fourth and the last session of the grouptherapy
measure: Satisfaction of the treatment
timeFrame: 3, 6 and 12 months from the baseline
Locations:
city: Helsinki
country: Finland
facility: Finnish Institute of Occupational Health (Finland)
state: Uusimaa
Study officials:
affiliation: Finnish Institute of Occupational Health and University of Helsinki
name: Tiina M. Paunio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med. 2001 Jul;33(5):328-36. doi: 10.3109/07853890109002086.
citation: Tuomi T Ilmarinen J, Jahkola A, Katajarinne l, Tulkki A (1998) Work ability index. Finnish Institute of Occupational Health, Helsinki.
citation: Tuomisto MT, Lappalainen R, Tuomisto T, Timonen T. [Applied relaxation in psychiatry and behavioral therapy]. Duodecim. 1996;112(11):960-7. No abstract available. Finnish.
citation: Selinheimo S, Vuokko A, Hublin C, Jarnefelt H, Karvala K, Sainio M, Suojalehto H, Paunio T. Psychosocial treatments for employees with non-specific and persistent physical symptoms associated with indoor air: A randomised controlled trial with a one-year follow-up. J Psychosom Res. 2020 Feb 12;131:109962. doi: 10.1016/j.jpsychores.2020.109962. Online ahead of print.
citation: Selinheimo S, Vuokko A, Hublin C, Jarnefelt H, Karvala K, Sainio M, Suojalehto H, Suvisaari J, Paunio T. Health-related quality among life of employees with persistent nonspecific indoor-air-associated health complaints. J Psychosom Res. 2019 Jul;122:112-120. doi: 10.1016/j.jpsychores.2019.03.181. Epub 2019 Mar 25.
citation: Selinheimo S, Vuokko A, Sainio M, Karvala K, Suojalehto H, Jarnefelt H, Paunio T. Comparing cognitive-behavioural psychotherapy and psychoeducation for non-specific symptoms associated with indoor air: a randomised control trial protocol. BMJ Open. 2016 Jun 6;6(6):e011003. doi: 10.1136/bmjopen-2015-011003.