Comparing Interventions for Indoor Air -Related Functional Symptoms

Environmental Illness Clinical Trial

— TOSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069002
• Other study ID #: TSR113076
• Secondary ID: TTL338270202
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: July 30, 2018

Study information

• Verified date: February 2017
• Source: Finnish Institute of Occupational Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 30, 2018
• Est. primary completion date: July 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 58 Years

Eligibility

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.

Related Conditions & MeSH terms

• Environmental Illness
• Functional Symptoms

Intervention

Behavioral:
• Cognitive-Behavioral Therapy (CBT)

• Applied relaxation group therapy

• Information session (psychoeducation)

Locations

Country	Name	City	State
Finland	Finnish Institute of Occupational Health (Finland)	Helsinki	Uusimaa

Sponsors (8)

Lead Sponsor	Collaborator
Finnish Institute of Occupational Health	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

Country where clinical trial is conducted

Finland, 

References & Publications (3)

Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med. 2001 Jul;33(5):328-36. Review. — View Citation

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. Review. Finnish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	15D - instrument	The health-related quality of life (HRQoL) instrument (Sintonen, 2001)	baseline, 3, 6 and 12 months from the baseline
Secondary	• Generalized Anxiety Disorder (GAD-7)	Self-report measure that assesses anxiety symptoms	baseline, 3, 6 and 12 months from the baseline
Secondary	Insomnia Severity Index (ISI)	Self-report measure that assesses insomnia severity	baseline, 3, 6 and 12 months from the baseline
Secondary	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
Secondary	The Patient Health Questionnaire (PHQ-9)	Self-report measure that assesses depressive symptoms	baseline, 3, 6 and 12 months from the baseline
Secondary	Visual Analogue Scale (VAS)	Self-report measure that assesses respiratory symptom severity	baseline, 3, 6 and 12 months from the baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Strategy and Attribution Questionnaire (SAQ)	Self-report measure focuses on personal attribute strategies.	baseline, 6 and 12 months from the baseline
Secondary	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