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Trial record 3 of 8 for:    TTL

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Finnish Institute of Occupational Health.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02069002
First Posted: February 21, 2014
Last Update Posted: August 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
The Occupational Health Centre of the city of Helsinki
Information provided by (Responsible Party):
Finnish Institute of Occupational Health
  Purpose
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.

Condition Intervention
Environmental Illness Functional Symptoms Behavioral: Cognitive-Behavioral Therapy (CBT) Behavioral: Applied relaxation group therapy Behavioral: Information session (psychoeducation)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychosocial Interventions for Indoor Air -Related Functional Symptoms - Randomized Controlled Trial (RCT)

Further study details as provided by Finnish Institute of Occupational Health:

Primary Outcome Measures:
  • 15D - instrument [ Time Frame: baseline, 3, 6 and 12 months from the baseline ]
    The health-related quality of life (HRQoL) instrument (Sintonen, 2001)


Secondary Outcome Measures:
  • • Generalized Anxiety Disorder (GAD-7) [ Time Frame: baseline, 3, 6 and 12 months from the baseline ]
    Self-report measure that assesses anxiety symptoms

  • Insomnia Severity Index (ISI) [ Time Frame: baseline, 3, 6 and 12 months from the baseline ]
    Self-report measure that assesses insomnia severity

  • The Symptom checkList-90 (SCL-90) [ Time Frame: baseline, 6 and 12 months from the baseline ]
    Self-report measure that assesses general psychological and somatic symptoms and severity

  • The Patient Health Questionnaire (PHQ-9) [ Time Frame: baseline, 3, 6 and 12 months from the baseline ]
    Self-report measure that assesses depressive symptoms

  • Visual Analogue Scale (VAS) [ Time Frame: baseline, 3, 6 and 12 months from the baseline ]
    Self-report measure that assesses respiratory symptom severity

  • The Acceptance and Action Questionnaire-2 (AAQ-2) [ Time Frame: baseline, 3, 6 and 12 months from the baseline ]
    Self-report measure focuses on experiential avoidance and psychological inflexibility

  • Illness Worry Scale (IWS) [ Time Frame: baseline, 3, 6 and 12 months from the baseline ]
    Self-report measure that focuses on illness worries and attitudes towards illness

  • Penn State Worry Questionnaire (PSWQ) [ Time Frame: baseline, 3, 6 and 12 months from the baseline ]
    Self-report measure that focuses on mourning and continuous worrying toughs

  • Need for Recovery (NRF) [ Time Frame: baseline, 3, 6 and 12 months from the baseline ]
    Self-report measure that focuses on time needed on the recovery after work day

  • Strategy and Attribution Questionnaire (SAQ) [ Time Frame: baseline, 6 and 12 months from the baseline ]
    Self-report measure focuses on personal attribute strategies.

  • Self-assessed work ability [ Time Frame: baseline, 3, 6 and 12 months from the baseline ]
    Self-assessed work ability (on a scale 0-10) (Tuomi & al. 1998)


Other Outcome Measures:
  • Working Alliance Inventory (WAI) [ Time Frame: after the first, fifth and the last session of the CBT ]
    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

  • Sense of coherence Group (SOC-G-20) [ Time Frame: after the first, fourth and the last session of the grouptherapy ]
    For the group therapy patients to evaluate the groups therapeutic alliance.

  • Satisfaction of the treatment [ Time Frame: 3, 6 and 12 months from the baseline ]
    Questionnaire for the intervention groups patients to evaluate the satisfaction of the treatment and its efficacy.


Estimated Enrollment: 120
Study Start Date: January 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069002


Contacts
Contact: Tiina M. Paunio, MD, PhD + 358 50 3507936 tiina.paunio@ttl.fi
Contact: Sanna I. Selinheimo, MA (psych.) +358 50 311 2583 sanna.selinheimo@ttl.fi

Locations
Finland
Finnish Institute of Occupational Health (Finland) Recruiting
Helsinki, Uusimaa, Finland, 00250
Contact: Tiina M. Paunio, PhD    + 358 50 3507936    tiina.paunio@ttl.fi   
Contact: Sanna I. Selinheimo, Ma (psych.)    +358 50 311 2583    sanna.selinheimo@ttl.fi   
Principal Investigator: Tiina M. Paunio, PhD         
Sponsors and Collaborators
Finnish Institute of Occupational Health
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
The Occupational Health Centre of the city of Helsinki
Investigators
Principal Investigator: Tiina M. Paunio, MD, PhD Finnish Institute of Occupational Health and University of Helsinki
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Finnish Institute of Occupational Health
ClinicalTrials.gov Identifier: NCT02069002     History of Changes
Other Study ID Numbers: TSR113076
TTL338270202 ( Other Grant/Funding Number: Finnish Institute of Occupational Health (Finland) )
First Submitted: February 20, 2014
First Posted: February 21, 2014
Last Update Posted: August 14, 2015
Last Verified: August 2015

Keywords provided by Finnish Institute of Occupational Health:
Indoor Air
Medically unexplained symptoms
Randomized controlled trial
Cognitive-Behavioral Therapy
Applied relaxation

Additional relevant MeSH terms:
Environmental Illness
Hypersensitivity
Immune System Diseases
Disorders of Environmental Origin