NCT02069002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

August 7, 2018

Status Verified

February 1, 2017

Enrollment Period

4.5 years

First QC Date

February 20, 2014

Last Update Submit

August 6, 2018

Conditions

Environmental IllnessFunctional Symptoms

Keywords

Indoor AirMedically unexplained symptomsRandomized controlled trialCognitive-Behavioral TherapyApplied relaxation

Outcome Measures

Primary Outcomes (1)

  • 15D - instrument

    The health-related quality of life (HRQoL) instrument (Sintonen, 2001)

    baseline, 3, 6 and 12 months from the baseline

Secondary Outcomes (11)

  • • Generalized Anxiety Disorder (GAD-7)

    baseline, 3, 6 and 12 months from the baseline

  • Insomnia Severity Index (ISI)

    baseline, 3, 6 and 12 months from the baseline

  • The Symptom checkList-90 (SCL-90)

    baseline, 6 and 12 months from the baseline

  • The Patient Health Questionnaire (PHQ-9)

    baseline, 3, 6 and 12 months from the baseline

  • Visual Analogue Scale (VAS)

    baseline, 3, 6 and 12 months from the baseline

  • +6 more secondary outcomes

Other Outcomes (3)

  • Working Alliance Inventory (WAI)

    after the first, fifth and the last session of the CBT

  • Sense of coherence Group (SOC-G-20)

    after the first, fourth and the last session of the grouptherapy

  • Satisfaction of the treatment

    3, 6 and 12 months from the baseline

Study Arms (3)

Cognitive-Behavioral Therapy (CBT)

EXPERIMENTAL

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)

Applied relaxation group therapy

EXPERIMENTAL

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

Information session (psychoeducation)

EXPERIMENTAL

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)

Interventions

Cognitive-Behavioral Therapy (CBT)BEHAVIORAL
Cognitive-Behavioral Therapy (CBT)
Applied relaxation group therapyBEHAVIORAL
Applied relaxation group therapy
Information session (psychoeducation)BEHAVIORAL
Information session (psychoeducation)

Eligibility Criteria

Age25 Years - 58 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Self-assessed work ability not more than 7 (on a scale 0-10, compared to lifetime best) (removed, see below)
  • Employed minimum three (3) or more years
  • Symptoms related to work environment indoor air (non-industrial workplaces)
  • Respiratory symptoms related to indoor air
  • And symptoms involve more than one other organ system
  • Symptoms onset maximum three years before the study
  • Symptoms are recurrent
  • Symptoms appear more than one (1) environment or continue after repairs environmental exposure(s)
  • No single widely acceptable test of organ system function can explain the symptoms (symptoms are medically unexplained)
  • Minimum of one sick leave due to indoor air symptoms during the preceding half year
  • Fluent Finnish (write/read/speak) (due the interventions)

You may not qualify if:

  • six (6) months or more sick leave sick leaves due to indoor air symptoms during the preceding two years and currently unable to work
  • Planned changes in the work (for example retirement, study free period, pregnancy etc.) during the study
  • An acute, untreated medical disorder or illnesses:
  • Somatic disease that explains the symptoms
  • An acute, untreated mental disorder (depression, bipolar disorder, psychotic disorders, obsessive-compulsive disorder, eating disorders, personality disorders)
  • Abuse of narcotics or alcohol or (non-prescribed) medicine
  • Developmental disorders
  • Psychotherapy (current or has ended preceding two years)
  • No inform consent
  • Other: Patient refusal; not actively participating working life (retired or unemployed)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finnish Institute of Occupational Health (Finland)

Helsinki, Uusimaa, 00250, Finland

Location

Related Publications (6)

  • 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.

    PMID: 11491191BACKGROUND

  • Tuomi T Ilmarinen J, Jahkola A, Katajarinne l, Tulkki A (1998) Work ability index. Finnish Institute of Occupational Health, Helsinki.

    BACKGROUND

  • 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.

    PMID: 10592988BACKGROUND

  • 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 Apr;131:109962. doi: 10.1016/j.jpsychores.2020.109962. Epub 2020 Feb 12.

    PMID: 32078837DERIVED

  • 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.

    PMID: 30935665DERIVED

  • 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.

    PMID: 27266771DERIVED

MeSH Terms

Conditions

Environmental IllnessMedically Unexplained Symptoms

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

HypersensitivityImmune System DiseasesDisorders of Environmental OriginSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tiina M. Paunio, MD, PhD

    Finnish Institute of Occupational Health and University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2014

First Posted

February 21, 2014

Study Start

February 1, 2014

Primary Completion

July 29, 2018

Study Completion

July 30, 2018

Last Updated

August 7, 2018

Record last verified: 2017-02

Locations

FI(1)