Environmental IllnessTOSINCT02069002
Comparing Interventions for Indoor Air -Related Functional Symptoms
A study testing Cognitive-Behavioral Therapy (CBT), Applied relaxation group therapy and Information session (psychoeducation) in people with Environmental Illness and Functional Symptoms, run by Finnish Institute of Occupational Health at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 58 years
- Conditions the study is for
- Environmental Illness, Functional Symptoms
- What is being tested?
- Cognitive-Behavioral Therapy (CBT), Applied relaxation group therapy and Information session (psychoeducation)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2014to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Finnish Institute of Occupational Health (Finland)
Helsinki, Uusimaa, 00250
About this study
Official title: Psychosocial Interventions for Indoor Air -Related Functional Symptoms - Randomized Controlled Trial (RCT)
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.
Read the 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
- Environmental Illness, Functional Symptoms
- Being tested
- Cognitive-Behavioral Therapy (CBT), Applied relaxation group therapy, Information session (psychoeducation)
- Keywords
- Indoor Air, Medically unexplained symptoms, Randomized controlled trial, Cognitive-Behavioral Therapy, Applied relaxation
- Medical subject headings
- Environmental Illness, Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy (CBT)Behavioural
Applied relaxation group therapyBehavioural
Information session (psychoeducation)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Experimental | There will be ten (10) manualized session, fist 90 minutes and nine (9) 45-minute individual sessions conducted at weekly intervals, last two sessions 2 weeks intervals. One booster session will be conducted three months after the treatment. Sessions include psychoeducation about indoor air related symptoms and personal health behavior factors integrated on patients individual symptomatology, cognitive restructuring, behavioral experiments of patients health promoting behavior, imagery rescripting and relapse prevention.
Intervention: Behavioral: Psychotherapy (CBT) Receives: Behavioral: Cognitive-Behavioral Therapy (CBT) |
| Applied relaxation group therapy | Experimental | There will be seven (7) manualized session, first 120 minutes and six (6) 90-minute group sessions conducted at weekly intervals, last two sessions 2 weeks intervals. One booster session will be conducted three months after treatment. Sessions include information about indoor air related symptoms, behavioral training and experiments focusing on applied relaxation technique and relapse prevention.
Intervention: Behavioral: group therapy (ART)
NB: The Applied Relaxation group Therapy won´t be carried out due to slow and prolonged recruiting process (A steering group agreement 4/2015 and the Ethics Committee approval 5/2015 for the change of the study plan). Receives: Behavioral: Applied relaxation group therapy |
| Information session (psychoeducation) | Experimental | There will be one (1) manualized 90-minute individual session. The session includes information about indoor air related symptoms and factors affecting individual health behavior.
Intervention: Information session (psychoeducation) Receives: Behavioral: Information session (psychoeducation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
15D - instrument
The health-related quality of life (HRQoL) instrument (Sintonen, 2001)
Measured: baseline, 3, 6 and 12 months from the baseline
Secondary outcomes (11)
• Generalized Anxiety Disorder (GAD-7)
Self-report measure that assesses anxiety symptoms
Measured: baseline, 3, 6 and 12 months from the baseline
Insomnia Severity Index (ISI)
Self-report measure that assesses insomnia severity
Measured: baseline, 3, 6 and 12 months from the baseline
The Symptom checkList-90 (SCL-90)
Self-report measure that assesses general psychological and somatic symptoms and severity
Measured: baseline, 6 and 12 months from the baseline
The Patient Health Questionnaire (PHQ-9)
Self-report measure that assesses depressive symptoms
Measured: baseline, 3, 6 and 12 months from the baseline
Visual Analogue Scale (VAS)
Self-report measure that assesses respiratory symptom severity
Measured: baseline, 3, 6 and 12 months from the baseline
The Acceptance and Action Questionnaire-2 (AAQ-2)
Self-report measure focuses on experiential avoidance and psychological inflexibility
Measured: baseline, 3, 6 and 12 months from the baseline
Illness Worry Scale (IWS)
Self-report measure that focuses on illness worries and attitudes towards illness
Measured: baseline, 3, 6 and 12 months from the baseline
Penn State Worry Questionnaire (PSWQ)
Self-report measure that focuses on mourning and continuous worrying toughs
Measured: baseline, 3, 6 and 12 months from the baseline
Need for Recovery (NRF)
Self-report measure that focuses on time needed on the recovery after work day
Measured: baseline, 3, 6 and 12 months from the baseline
Strategy and Attribution Questionnaire (SAQ)
Self-report measure focuses on personal attribute strategies.
Measured: baseline, 6 and 12 months from the baseline
Self-assessed work ability
Self-assessed work ability (on a scale 0-10) (Tuomi \& al. 1998)
Measured: baseline, 3, 6 and 12 months from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion29 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Environmental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute of Occupational Health
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Work Environment Fund, The Social Insurance Institution of Finland, The Occupational Health Centre of the city of Espoo, Terveystalo healthcare service company (Finland), Mehiläinen Oy healthcare service company (Finland), The Occupational Health Centre of the city of Vantaa, City of Helsinki
- Responsible party
- Sponsor
- Investigators
- Tiina M. Paunio, MD, PhD, Principal investigator, Finnish Institute of Occupational Health and University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069002
- Sponsor's protocol ID
- TSR113076
- Other IDs
- TTL338270202
- Acronym
- TOSI
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2014
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11491191Tuomi T Ilmarinen J, Jahkola A, Katajarinne l, Tulkki A (1998) Work ability index. Finnish Institute of Occupational Health, Helsinki.
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.
PubMed 10592988Selinheimo 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 Apr;131:109962. doi: 10.1016/j.jpsychores.2020.109962. Epub 2020 Feb 12.
PubMed 32078837Selinheimo 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.
PubMed 30935665Selinheimo 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.
PubMed 27266771
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Interventions for Indoor Air -Related Functional Symptoms - Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT02069002
- Acronym / sponsor ID
- TOSI / TSR113076
- Conditions
- Environmental Illness, Functional Symptoms
- Keywords
- Indoor Air, Medically unexplained symptoms, Randomized controlled trial, Cognitive-Behavioral Therapy, Applied relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Finnish Institute of Occupational HealthUniversity, hospital or other
- Collaborators
- Finnish Work Environment Fund, The Social Insurance Institution of Finland, The Occupational Health Centre of the city of Espoo, Terveystalo healthcare service company (Finland), Mehiläinen Oy healthcare service company (Finland), The Occupational Health Centre of the city of Vantaa, City of Helsinki
- Study start
- Feb 2014 (actual)
- Primary completion
- 29 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Experimental | Behavioral: Cognitive-Behavioral Therapy (CBT)There will be ten (10) manualized session, fist 90 minutes and nine (9) 45-minute individual sessions conducted at weekly intervals, last two sessions 2 weeks intervals. One booster session will be conducted three months after the treatment. Sessions include psychoeducation about indoor air related symptoms and personal health behavior factors integrated on patients individual symptomatology, cognitive restructuring, behavioral experiments of patients health promoting behavior, imagery rescripting and relapse prevention. Intervention: Behavioral: Psychotherapy (CBT) |
| Applied relaxation group therapy | Experimental | Behavioral: Applied relaxation group therapyThere will be seven (7) manualized session, first 120 minutes and six (6) 90-minute group sessions conducted at weekly intervals, last two sessions 2 weeks intervals. One booster session will be conducted three months after treatment. Sessions include information about indoor air related symptoms, behavioral training and experiments focusing on applied relaxation technique and relapse prevention. Intervention: Behavioral: group therapy (ART) NB: The Applied Relaxation group Therapy won´t be carried out due to slow and prolonged recruiting process (A steering group agreement 4/2015 and the Ethics Committee approval 5/2015 for the change of the study plan). |
| Information session (psychoeducation) | Experimental | Behavioral: Information session (psychoeducation)There will be one (1) manualized 90-minute individual session. The session includes information about indoor air related symptoms and factors affecting individual health behavior. Intervention: Information session (psychoeducation) |
Who may qualify
- Ages
- 25 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
- Psychotherapy (current or has ended preceding two years)
- No inform consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Behavioural | Cognitive-Behavioral Therapy (CBT) |
| Applied relaxation group therapy | Behavioural | Applied relaxation group therapy |
| Information session (psychoeducation) | Behavioural | Information session (psychoeducation) |
Primary outcome
15D - instrument
Time frame: baseline, 3, 6 and 12 months from the baseline
The health-related quality of life (HRQoL) instrument (Sintonen, 2001)
11 secondary outcomes
• Generalized Anxiety Disorder (GAD-7)
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
The Symptom checkList-90 (SCL-90)
Time frame: baseline, 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
The Acceptance and Action Questionnaire-2 (AAQ-2)
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
Penn State Worry Questionnaire (PSWQ)
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
Strategy and Attribution Questionnaire (SAQ)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Background: PubMed 11491191Sintonen 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.
- BackgroundTuomi T Ilmarinen J, Jahkola A, Katajarinne l, Tulkki A (1998) Work ability index. Finnish Institute of Occupational Health, Helsinki.
- Background: PubMed 10592988Tuomisto MT, Lappalainen R, Tuomisto T, Timonen T. [Applied relaxation in psychiatry and behavioral therapy]. Duodecim. 1996;112(11):960-7. No abstract available. Finnish.
- Derived from this study: PubMed 32078837Selinheimo 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 Apr;131:109962. doi: 10.1016/j.jpsychores.2020.109962. Epub 2020 Feb 12.
- Derived from this study: PubMed 30935665Selinheimo 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.
- Derived from this study: PubMed 27266771Selinheimo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiina M. Paunio, MD, PhD principal investigator
Finnish Institute of Occupational Health and University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy (CBT), Applied relaxation group therapy and Information session (psychoeducation) in people with Environmental Illness and Functional Symptoms, run by Finnish Institute of Occupational Health at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
15D - instrument (time frame: baseline, 3, 6 and 12 months from the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02069002, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.