Comparing Interventions for Indoor Air -Related Functional Symptoms (TOSI)

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.

Study Overview

• Status: Completed
• Conditions: Environmental Illness; Functional Symptoms
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Therapy (CBT); Behavioral: Applied relaxation group therapy; Behavioral: Information session (psychoeducation)

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00250
      • Finnish Institute of Occupational Health (Finland)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Behavioral: Cognitive-Behavioral Therapy (CBT)
Experimental: Applied relaxation group therapy; 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).	Behavioral: Applied relaxation group therapy
Experimental: 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)	Behavioral: Information session (psychoeducation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
15D - instrument	The health-related quality of life (HRQoL) instrument (Sintonen, 2001)	baseline, 3, 6 and 12 months from the baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Generalized Anxiety Disorder (GAD-7)	Self-report measure that assesses anxiety symptoms	baseline, 3, 6 and 12 months from the baseline
Insomnia Severity Index (ISI)	Self-report measure that assesses insomnia severity	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	baseline, 6 and 12 months from the baseline
The Patient Health Questionnaire (PHQ-9)	Self-report measure that assesses depressive symptoms	baseline, 3, 6 and 12 months from the baseline
Visual Analogue Scale (VAS)	Self-report measure that assesses respiratory symptom severity	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	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	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	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	baseline, 3, 6 and 12 months from the baseline
Strategy and Attribution Questionnaire (SAQ)	Self-report measure focuses on personal attribute strategies.	baseline, 6 and 12 months from the baseline
Self-assessed work ability	Self-assessed work ability (on a scale 0-10) (Tuomi & al. 1998)	baseline, 3, 6 and 12 months from the baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working Alliance Inventory (WAI)	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	after the first, fifth and the last session of the CBT
Sense of coherence Group (SOC-G-20)	For the group therapy patients to evaluate the groups therapeutic alliance.	after the first, fourth and the last session of the grouptherapy
Satisfaction of the treatment	Questionnaire for the intervention groups patients to evaluate the satisfaction of the treatment and its efficacy.	3, 6 and 12 months from the baseline

Collaborators and Investigators

• Sponsor: Finnish Institute of Occupational Health
• Collaborators: City of Helsinki; 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
• Investigators: Principal Investigator: Tiina M. Paunio, MD, PhD, Finnish Institute of Occupational Health and University of Helsinki

Publications and helpful links

General 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.
• Tuomi 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.
• 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.
• 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.
• 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. Erratum In: BMJ Open. 2017 Apr 22;7(4):e011003corr1.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): July 29, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: February 20, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Medically unexplained symptoms; Cognitive-Behavioral Therapy; Indoor Air; Applied relaxation
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Disorders of Environmental Origin; Environmental Illness
• Other Study ID Numbers: TSR113076; TTL338270202 (Other Grant/Funding Number: Finnish Institute of Occupational Health (Finland))

Plan for Individual participant data (IPD)

Study Data/Documents

1. Study Protocol