Clinical Trial: Comparing Interventions for Indoor Air -Related Functional Symptoms

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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. Parti
Sponsor: Finnish Institute of Occupational Health

Current 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • • 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)


Original Secondary Outcome:

  • • 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 ans 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)


Information By: Finnish Institute of Occupational Health

Dates:
Date Received: February 20, 2014
Date Started: January 2014
Date Completion: June 2016
Last Updated: August 13, 2015
Last Verified: August 2015