Comparing cognitive-behavioural psychotherapy and psychoeducation for non-specific symptoms associated with indoor air: a randomised control trial protocol

Sanna Selinheimo, Aki Vuokko, Markku Sainio, Kirsi Karvala, Hille Suojalehto, Heli Järnefelt, Tiina Paunio, Sanna Selinheimo, Aki Vuokko, Markku Sainio, Kirsi Karvala, Hille Suojalehto, Heli Järnefelt, Tiina Paunio

Abstract

Introduction: Indoor air-related conditions share similarities with other conditions that are characterised by medically unexplained symptoms (MUS)-a combination of non-specific symptoms that cannot be fully explained by structural bodily pathology. In cases of indoor air-related conditions, these symptoms are not fully explained by either medical conditions or the immunological-toxicological effects of environmental factors. The condition may be disabling, including a non-adaptive health behaviour. In this multifaceted phenomenon, psychosocial factors influence the experienced symptoms. Currently, there is no evidence of clinical management of symptoms, which are associated with the indoor environment and cannot be resolved by removing the triggering environmental factors. The aim of this study is to compare the effect of treatment-as-usual (TAU) and two psychosocial interventions on the quality of life, and the work ability of employees with non-specific indoor air-related symptomatology.

Methods and analyses: The aim of this ongoing randomised controlled trial is to recruit 60 participants, in collaboration with 5 occupational health service units. The main inclusion criterion is the presence of indoor air-related recurrent symptoms in ≥2 organ systems, which have no pathophysiological explanation. After baseline clinical investigations, participants are randomised into interventions, which all include TAU: cognitive-behavioural psychotherapy, psychoeducation and TAU (control condition). Health-related quality of life, measured using the 15D-scale, is the primary outcome. Secondary outcomes include somatic and psychiatric symptoms, occupational factors, and related underlying mechanisms (ie, cognitive functioning). Questionnaires are completed at baseline, at 3, 6 and 12-month follow-ups. Data collection will continue until 2017. The study will provide new information on the individual factors related to indoor air-associated symptoms, and on ways in which to support work ability.

Ethics and dissemination: The Coordinating Ethics Committee of the Hospital District of Helsinki and Uusimaa, Finland, has granted approval for the study. The results will be published in peer-reviewed journals.

Trial registration number: NCT02069002; Pre-results.

Keywords: Cognitive-behavioural therapy; Idiopathic environmental intolerance; Indoor air; Medically unexplained symptoms; Randomized controlled tria.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Cognitive-behavioural model of hypothesised cycle of symptom perpetuation (extended after Deary et al27) and the focus of the present RCT study (encircled). The focus is part of a multifactorial approach to managing symptoms associated with indoor air. RCT, randomised controlled trial.
Figure 2
Figure 2
Flow chart of study. *OHS (A to E) join the study consecutively: (A and B) in January 2014, (C) in June 2014, (D) in August 2014, and (E) in March 2015. Participant recruitment began: (A and B) in 24th February 2014, (C) in July 2014, (D) in September 2014 and (E) in May 2015. **AR Group Therapy discontinued during study due to slow, prolonged recruitment process. FIOH, Finnish Institute of Occupational Health; OHS, occupational health service.

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