Persistent Physical SymptomsDigiPimoNCT04532827
Web-based Rehabilitation for Persistent Physical Symptoms.
A study testing Case formulation with web-program in people with Persistent Physical Symptoms and Indoor Environment Associated Symptoms, run by Finnish Institute of Occupational Health at 1 site in Finland.
Trial summary
Persistent physical symptoms (PPS) might diminish studying or workability and daily functioning without a clear medical or environment-related explanation. Psychosocial, patient-involving treatments that support individuals' abilities managing with the PPS and health behaviours have shown promising effects in treating… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persistent Physical Symptoms, Indoor Environment Associated Symptoms, Indoor Air Associated Symptoms
- What is being tested?
- Case formulation with web-program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFinland
- Study dates
- 18 Aug 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent Finnish (web-program is in Finnish)
- Duration of the symptoms Onset of symptoms with disability maximum of 3 years before the study
- Symptomatology A) Indoor air-related symptoms or B) Persistent, chronic fatigue
- Indoor air-related symptoms
- Self-reported symptoms attributed to indoor (non-industrial) environments include: i) symptoms from at least two different organ systems eg. respiratory, digestive or nervous system.
- Symptoms recurrently i) occur in more than one indoor environment or ii) continue despite environmental improvements (e.g. study or work arrangements and/or workplace repairs)
Show all 12Show fewer
- or
- Chronic fatigue
- Post-exertional malaise and/ or post-exertional fatigue.
- Unrefreshing sleep or disturbance of sleep quantity or rhythm disturbance.
- Multiorgan symptoms i) Pain, often widespread, ii) Two of more neurological or cognitive symptoms, iii) At least two symptoms of following categories: Autonomic manifestations, neuroendocrine manifestations or immune manifestations
- Duration and severity of the condition: Symptoms minimum of six months; Symptoms are not lifelong and result in substantial functional restrictions in daily life.
Who cannot join
- Work situation: Long sick leave (≥3 months) without return to work plan, not actively participating in study or work life (retired or unemployed)
- Medical reasons
- Some serious and/or acute medical disease or illness explains the symptoms i) Somatic disease that explains the symptoms (e.g. uncontrolled asthma, hypothyroidism, sleep apnea)
- Psychiatric disorder (bipolar disorder, psychotic disorders, alcohol and/or drug dependency or abuse, eating disorders, and/or severe mood disorders)
- Developmental disorders
- Current psychotherapy
- Other Patient refusal
Trial locations and contacts
1 site in 1 country.
Finland1 site
Finnish Institute of Occupational Health
Helsinki, Uusimaa, 00270
About this study
Official title: The Effectiveness of Web-based Rehabilitation for Enhancing Workability and Daily Functioning for Persistent Physical Symptoms.
Persistent physical symptoms (PPS) might diminish studying or workability and daily functioning without a clear medical or environment-related explanation. Psychosocial, patient-involving treatments that support individuals' abilities managing with the PPS and health behaviours have shown promising effects in treating PPS but the acceptability of these treatments among symptomatic individuals is low.
This study aims to assess the effectiveness of an eHealth intervention based on relational frame theory and acceptance and commitment therapy on PPS with two focus groups, among participants with indoor air associated disabling symptoms or persistent, chronic fatigue.
Read more
This study will compare web program enhanced with video-based individual case formulation with treatment as usual. The web program includes 10 one weeks (pilot included 6 two weeks) modules. In addition to patient-reported outcomes, ecological momentary assessments are conducted to provide real-time data on functioning and national registers are used to obtain information on health-care use and social benefits.
Data collection begins in August 2020 and will continue until 2023.
Read the detailed description
Background: Frequent physical symptoms are common in the general population with over 90 per cent of the population reporting symptoms at some level. In some cases, they become persistent diminishing workability and daily functioning and associate with increased healthcare usage and sick leaves independently of other somatic or psychiatric comorbidities. Persistent physical symptoms (PPS) challenge health care systems as it is estimated that up to 4-30 per cent of primary health care visits are due to PPS without a clear medical explanation. Psychosocial, patient-involving treatments, such as cognitive-behavioural psychotherapy (CBT), that support individuals' abilities managing with the PPS and health behaviours have shown promising effects in treating PPS but so far, evidence-based treatments have resulted only in small to moderate effect sizes. The acceptability of these treatments among symptomatic individuals is also low - presumably because of the stigma related to the ambiguity of the PPS´ status as a medical condition. A stronger orientation to personalized treatment protocols is needed to improve the treatment efficacy and applicability.
This study will assess the effects of an eHealth intervention based on relational frame theory and acceptance and commitment therapy on PPS with two focus groups, among participants with indoor air associated disabling symptoms or persistent, chronic fatigue.
Methods: Using a randomized controlled design (RCT) with two parallel groups in a 1:1 ratio, the investigators will compare ACT/RFT-based web program enhanced with individual case formulation with treatment as usual. The web program intervention includes 10 one weeks (pilot included 6 two weeks) modules that each ask to complete the module and included training in two weeks. The web program is in Finnish. Participants will be asked to complete outcome questionnaires at baseline before the interview for inclusion, after the interview (randomization) and at 3, 6- and 12-months' follow-up after the randomization. The intervention group receives also a questionnaire four weeks after the beginning of the web program. In addition, ecological momentary assessments are also conducted to provide real-time data on functioning and national registers are used to obtain information on healthcare use and social benefits to complete patient-reported outcomes.
Eligible participants will be randomized to either the intervention or to TAU. The primary outcome will be a health-related quality of life. The secondary outcome measures are symptoms, illness perceptions, psychological flexibility and workability. Further, the investigators will assess whether any effect of the intervention on the primary outcome is mediated by the case formulation. The baseline data collection begins in August 2020 and will continue until 2022, follow-up data collection will continue until 2023.
- Conditions
- Persistent Physical Symptoms, Indoor Environment Associated Symptoms, Indoor Air Associated Symptoms, Chronic Fatigue Syndrome
- Being tested
- Case formulation with web-program
- Keywords
- Indoor air, Persistent physical symptoms, Chronic Fatigue Syndrome, Web-based intervention, Rehabilitation, Indoor environment, EHealth
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case formulation with web-programBehavioural
The first meeting includes an interview to establish understanding on the participant´s symptomatology and current life situation, a case formulation (CF) will be build based on it. The CF is presented in the second session and modifications can be made to ensure acceptability for the participant. Goals for web program (WB) are set based on the CF and understanding of the factors contributing to the participant´s wellbeing.
WB modules are instructed to complete during the week. Modules include psychoeducation, experiential exercises and training aimed at improving wellbeing and psychological flexibility. Web-therapist will offer written feedback. The participants can contact the therapist via the WB and al messages will be replied within one week. Automatic reminders will be sent if a participant has not been active in the WB, the therapists will call participants who have discontinued using the WB.
| Study group | Role | What they receive |
|---|---|---|
| Case formulation with web-program | Experimental | The intervention will start with two video meetings with a psychologist to build up and present an individual case formulation, based on behavioural analysis, and to build up a shared decision of individual goals for the web program. The intervention continues with a web program consisting of ten manualized web-based modules, each at one-week intervals based on relational frame theory (RFT) and acceptance and commitment therapy (ACT). The pilot programme included six two-weeks modules and it was in use until 5/2021. The programme is in Finnish.
Both participants in the intervention arm and in the treatment as the usual arm will receive usual care, meaning that TAU will be enhanced with the study intervention in the intervention arm. In addition to TAU, all participants will be given self-help and educational leaflet based on scientific knowledge related to their condition. Receives: Behavioral: Case formulation with web-program |
| Treatment as usual | No intervention | Treatment as usual includes all the routine care that individual receives when he or she is presenting his or her symptoms at the primary or the occupational health care unit (corresponds primary care level treatment) or other unit that recommends the study for the participant. In practice, TAU may vary between the study participants based on their individual needs e.g. treatments for co-morbid somatic diseases or psychiatric disorders that this study will not interfere. Both participants in the intervention arm and in the treatment as usual arm will receive usual care, meaning that TAU will be enhanced with the study intervention in the intervention arm. In addition to TAU all participants will be given self-help and educational leaflet based on scientific knowledge related to their condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 15D questionnaire (health related quality of life)
The 15D is a utility-based generic, standardized measure, comprising the following 15 dimensions that describe physical, mental, and social well-being: mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. Each dimension is graded by the respondent on a scale ranging between 1 and 5, where 1 indicates an experience of no problems at all with the dimension and 5 indicates severe problems. Thus, the 15D can be used to measure a vast number of health states. We will use the 15D data both to derive 15D overall scores with values from 1 (full health) to 0 (being dead), and to obtain dimensional symptom profiles.
Measured: Chance from baseline (i.e. at self-referral) to after randomisation (i.e. after clinical assessment), and to 6 and 14 weeks and to 6 and to 12 months after randomisation
Secondary outcomes (45)
Demographic questions: age (years)
Measured: At baseline (i.e. at self-referral)
Demographic questions: gender (male, female, prefer not to say)
Measured: At baseline (i.e. at self-referral)
Demographic questions: marital status (Unmarried, married or cohabiting, divorced or separation, widow)
Measured: At baseline (i.e. at self-referral)
Demographic questions: education (basic, secondary, higher)
Measured: At baseline (i.e. at self-referral)
Demographic questions: daily exercise
One item of the frequency of the exercise on a six point likert scale (No weekly exercise - 4 times/week or more)
Measured: At baseline (i.e. at self-referral)
Demographic questions: Diet
Two items of the diet on a six point likert scale (have daily regular eating habits - have no regular eating habits; Caffeine consumption never - 7 or more proportion per day)
Measured: At baseline (i.e. at self-referral)
Social support and loneliness
Five questions of frequency of perceived loneliness and and social support in challenging situations (likert scale).
Measured: At baseline (i.e. at self-referral), and 12 months after randomisation
Smoking, Alcohol Use Disorders Identification Test (Audit-C)
Measured: At baseline (i.e. at self-referral), and 12 months after randomisation
Questions about health: Self-reported health
Five point likert scale (very poor - very good)
Measured: At baseline (i.e. at self-referral), and 12 months after randomisation
Questions about health: Self-reported diseases (diagnosed by medical doctor)
Measured: At baseline (i.e. at self-referral), and 12 months after randomisation
Questions about health: medication
Self-reported medication during past four weeks (name, dose, purpose of use)
Measured: At baseline (i.e. at self-referral), and 12 months after randomisation
Questions about health: Health care unit
An open question of the participant´s health care provider.
Measured: At baseline (i.e. at self-referral), and 12 months after randomisation
Questions about health: Information seeking
Questions about health information seeking from different sources (on a six point likert scale)
Measured: At baseline (i.e. at self-referral), and 12 months after randomisation
Questions about health: height in meters
height in meters to calculate BMI kg/m^2
Measured: At baseline (i.e. at self-referral)
Questions about health: weight in kilograms
weight in kilograms to calculate BMI kg/m^2
Measured: At baseline (i.e. at self-referral)
Work characteristics
Questions about participant work characteristics (working hours, field of industry etc)
Measured: At baseline (i.e. at self-referral), and 12 months after randomisation
Symptoms related to environmental factors
Questions whether environmental factors such as mold or water damage in buildings, electromagnetic fields, chemicals or indoor air have associated with symptoms and have they associated with avoidance behavior (yes - no).
Measured: At baseline (i.e. at self-referral), and 6 and 14 weeks and 6 and 12 months after randomisation
Health worries and health worries related to environmental factors
Questions about health worries in general and related to environmental factors (scale 0 not worried at all - 10 extremely worried)
Measured: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Environmental factors: influence on everyday life
Questions about the influence of environmental factors on everyday life (scale 0 no consequences - 10 severe consequences)
Measured: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Resiliency (SOC-3)
Measured: Time Frame: At baseline (i.e. at self-referral)
Personality Inventory (PK5)
Measured: Time Frame: At baseline (i.e. at self-referral)
Questions about sleep quality, sleeping patterns
Length of sleep (weekdays and weekends, hours)
Measured: At baseline (i.e. at self-referral), and 14 weeks, and, 6 and 12 months after randomisation
Questions about sleep quality, sleeping patterns
Nap (frequency per week and length, hours)
Measured: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Questions about sleep quality, sleeping patterns
Self-reported i) sleep quality, ii) night awakening iii) sleep disorders and iv) frequency of sleeping medicine usage at five point likert scale.
Measured: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Questions about sleep quality, sleeping patterns
Self-reported quality of rest and rhythmicity at four point likert scale.
Measured: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Fatigue
Questionnaire about perceived fatigue and its´consequences on daily functioning during past six months.
Measured: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Generalized Anxiety Disorder 7 (GAD-7)
Measured: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Insomnia Severity Index (ISI)
Measured: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Patient Health Questionnaire-15 (PHQ-15)
Measured: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
The Patient Health Questionnaire (PHQ-9)
Measured: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
AIDO Healthcare app: daily mood and fatigue
Measured: 1.5, 3.5 and 12 months after randomisation
The Acceptance and Action Questionnaire -II AAQ-7
Measured: At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation
Comprehensive assessment of Acceptance and Commitment Therapy CompACT
Measured: At baseline (i.e. at self-referral), and 14 weeks, 6 and 12 months after randomisation
Cognitive Fusion Questionnaire (CFQ-7)
Measured: At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation
Whiteley index -7 questionnaire
Measured: At baseline (i.e. at self-referral), and 14 weeks and 6 and 12 months after randomisation
White Bear Suppression Inventory (WBSI)
Measured: At baseline (i.e. at self-referral), after randomization and 14 weeks and, 6 and 12 months after randomisation
Five Facet Mindfulness Questionnaire (FFMQ)
Measured: At baseline (i.e. at self-referral), after randomization and 12 months after randomisation
Toronto alexithymia scale (TAS-20)
Measured: At baseline (i.e. at self-referral)
Illness Perception Questionnaire
Measured: At baseline (i.e. at self-referral) and 6 and 14 weeks and 6 and 12 months after randomisation
Self-assessed current ability to study or work
One question about current ability to study or work on a scale 1-10.
Measured: At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation
Own prognosis of ability to study or work two years from now
One question about of work ability two years from now (scale Unlikely; Not certain; Relatively certain)
Measured: At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation
Self-assessed stress and recovery
One question about stress and recovery on a scale 1-10.
Measured: At baseline (i.e. at self-referral) and 14 weeks and 6 and 12 months after randomisation
Daily functioning in three sub-domains.
Three questions about daily functioning (work, social life, home) on a scale 1-10 each
Measured: At baseline (i.e. at self-referral and 14 weeks and 6 and 12 months after randomisation
Working Alliance Inventory (WAI) - patient version for eHealth intervention
Measured: after randomization and 6 and 14 weeks after randomisation
Treatment satisfaction
Six items of treatment satisfaction based on Seligman´s report (1995). The effectiveness of psychotherapy: The Consumer Reports study. American psychologist, 50(12), 965.
Measured: after randomization and 6 and 14 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start18 Aug 2020
- Primary completion1 Jul 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Persistent Physical SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute of Occupational Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Social Insurance Institution of Finland, Hospital District of Helsinki and Uusimaa
- Responsible party
- Sponsor
- Investigators
- Tiina Paunio, Professor, Principal investigator, University of Helsinki, Finnish Institute of Occupational Health, the Hospital District of Helsinki and Uusimaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532827
- Sponsor's protocol ID
- 3531101
- Acronym
- DigiPimo
- Status last verified
- Jan 2023
- First submitted
- 18 Aug 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD that underlie results in a publication could be published But: study participants choose in informed consent that do they accept that their IPD will be published (anonymized). If they choose 'no´, their data won´t be published. Thus the preliminary plan is not to share the IPD (´undecided' would be accurate as well).
Publications
Selinheimo S, Vuokko A, Lappalainen P, Keinonen K, Tolvanen A, Lappalainen R, Sainio M, Paunio T. The Role of Psychological Flexibility in Health-Related Quality of Life Among Patients With Persistent Physical Symptoms Associated With Indoor Environment and Chronic Fatigue - 9-Month Follow-Up of a Randomized Controlled Trial. Int J Behav Med. 2026 Jul 14. doi: 10.1007/s12529-026-10477-z. Online ahead of print.
PubMed 42449061Vuokko A, Immonen M, Lappalainen P, Keinonen K, Sainio M, Lappalainen R, Paunio T, Selinheimo S. Work Ability and Functioning Among Individuals with Persistent Indoor Environment-Related Symptoms or Chronic Fatigue: Nine-Month Follow-Up of a Web-Based Randomized Controlled Trial. J Occup Rehabil. 2026 Apr 25. doi: 10.1007/s10926-026-10400-z. Online ahead of print.
PubMed 42033546Selinheimo S, Vuokko A, Lappalainen P, Keinonen K, Sainio M, Lappalainen R, Paunio T. The association between quality of life and psychological flexibility, depressive, anxiety or insomnia symptoms in patients with persistent indoor environment-related symptoms or chronic fatigue. BMC Psychol. 2025 Mar 11;13(1):229. doi: 10.1186/s40359-025-02549-8.
PubMed 40069901Lappalainen P, Keinonen K, Lappalainen R, Selinheimo S, Vuokko A, Sainio M, Liesto S, Tolvanen A, Paunio T. Online acceptance and commitment therapy (iACT) for adults with persistent physical symptoms - 3-month follow-up study of a randomized controlled trial. J Psychosom Res. 2024 Aug;183:111830. doi: 10.1016/j.jpsychores.2024.111830. Epub 2024 Jun 13.
PubMed 38878337Selinheimo S, Keinonen K, Vuokko A, Liesto S, Sainio M, Lappalainen R, Paunio T. A randomized controlled trial protocol for persistent physical symptoms associated with indoor environment or chronic fatigue: Effectiveness of video-based functional case conceptualization and web-program for improving quality of life. Front Psychol. 2023 Jan 6;13:923532. doi: 10.3389/fpsyg.2022.923532. eCollection 2022.
PubMed 36687807
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Web-based Rehabilitation for Enhancing Workability and Daily Functioning for Persistent Physical Symptoms.
- ClinicalTrials.gov ID
- NCT04532827
- Acronym / sponsor ID
- DigiPimo / 3531101
- Conditions
- Persistent Physical Symptoms, Indoor Environment Associated Symptoms, Indoor Air Associated Symptoms, Chronic Fatigue Syndrome
- Keywords
- Indoor air, Persistent physical symptoms, Chronic Fatigue Syndrome, Web-based intervention, Rehabilitation, Indoor environment, EHealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Finnish Institute of Occupational HealthUniversity, hospital or other
- Collaborators
- The Social Insurance Institution of Finland, Hospital District of Helsinki and Uusimaa
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Persistent physical symptoms (PPS) might diminish studying or workability and daily functioning without a clear medical or environment-related explanation. Psychosocial, patient-involving treatments that support individuals' abilities managing with the PPS and health behaviours have shown promising effects in treating PPS but the acceptability of these treatments among symptomatic individuals is low.
This study aims to assess the effectiveness of an eHealth intervention based on relational frame theory and acceptance and commitment therapy on PPS with two focus groups, among participants with indoor air associated disabling symptoms or persistent, chronic fatigue.
This study will compare web program enhanced with video-based individual case formulation with treatment as usual. The web program includes 10 one weeks (pilot included 6 two weeks) modules. In addition to patient-reported outcomes, ecological momentary assessments are conducted to provide real-time data on functioning and national registers are used to obtain information on health-care use and social benefits.
Data collection begins in August 2020 and will continue until 2023.
Detailed description
Background: Frequent physical symptoms are common in the general population with over 90 per cent of the population reporting symptoms at some level. In some cases, they become persistent diminishing workability and daily functioning and associate with increased healthcare usage and sick leaves independently of other somatic or psychiatric comorbidities. Persistent physical symptoms (PPS) challenge health care systems as it is estimated that up to 4-30 per cent of primary health care visits are due to PPS without a clear medical explanation. Psychosocial, patient-involving treatments, such as cognitive-behavioural psychotherapy (CBT), that support individuals' abilities managing with the PPS and health behaviours have shown promising effects in treating PPS but so far, evidence-based treatments have resulted only in small to moderate effect sizes. The acceptability of these treatments among symptomatic individuals is also low - presumably because of the stigma related to the ambiguity of the PPS´ status as a medical condition. A stronger orientation to personalized treatment protocols is needed to improve the treatment efficacy and applicability.
This study will assess the effects of an eHealth intervention based on relational frame theory and acceptance and commitment therapy on PPS with two focus groups, among participants with indoor air associated disabling symptoms or persistent, chronic fatigue.
Methods: Using a randomized controlled design (RCT) with two parallel groups in a 1:1 ratio, the investigators will compare ACT/RFT-based web program enhanced with individual case formulation with treatment as usual. The web program intervention includes 10 one weeks (pilot included 6 two weeks) modules that each ask to complete the module and included training in two weeks. The web program is in Finnish. Participants will be asked to complete outcome questionnaires at baseline before the interview for inclusion, after the interview (randomization) and at 3, 6- and 12-months' follow-up after the randomization. The intervention group receives also a questionnaire four weeks after the beginning of the web program. In addition, ecological momentary assessments are also conducted to provide real-time data on functioning and national registers are used to obtain information on healthcare use and social benefits to complete patient-reported outcomes.
Eligible participants will be randomized to either the intervention or to TAU. The primary outcome will be a health-related quality of life. The secondary outcome measures are symptoms, illness perceptions, psychological flexibility and workability. Further, the investigators will assess whether any effect of the intervention on the primary outcome is mediated by the case formulation. The baseline data collection begins in August 2020 and will continue until 2022, follow-up data collection will continue until 2023.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case formulation with web-program | Experimental | Behavioral: Case formulation with web-programThe intervention will start with two video meetings with a psychologist to build up and present an individual case formulation, based on behavioural analysis, and to build up a shared decision of individual goals for the web program. The intervention continues with a web program consisting of ten manualized web-based modules, each at one-week intervals based on relational frame theory (RFT) and acceptance and commitment therapy (ACT). The pilot programme included six two-weeks modules and it was in use until 5/2021. The programme is in Finnish. Both participants in the intervention arm and in the treatment as the usual arm will receive usual care, meaning that TAU will be enhanced with the study intervention in the intervention arm. In addition to TAU, all participants will be given self-help and educational leaflet based on scientific knowledge related to their condition. |
| Treatment as usual | No intervention | –Treatment as usual includes all the routine care that individual receives when he or she is presenting his or her symptoms at the primary or the occupational health care unit (corresponds primary care level treatment) or other unit that recommends the study for the participant. In practice, TAU may vary between the study participants based on their individual needs e.g. treatments for co-morbid somatic diseases or psychiatric disorders that this study will not interfere. Both participants in the intervention arm and in the treatment as usual arm will receive usual care, meaning that TAU will be enhanced with the study intervention in the intervention arm. In addition to TAU all participants will be given self-help and educational leaflet based on scientific knowledge related to their condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Fluent Finnish (web-program is in Finnish)
- Duration of the symptoms Onset of symptoms with disability maximum of 3 years before the study
- Symptomatology A) Indoor air-related symptoms or B) Persistent, chronic fatigue
- Indoor air-related symptoms
- Self-reported symptoms attributed to indoor (non-industrial) environments include: i) symptoms from at least two different organ systems eg. respiratory, digestive or nervous system.
Key exclusion criteria (7 listed)
- Work situation: Long sick leave (≥3 months) without return to work plan, not actively participating in study or work life (retired or unemployed)
- Medical reasons
- Current psychotherapy
- Other Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case formulation with web-programThe first meeting includes an interview to establish understanding on the participant´s symptomatology and current life situation, a case formulation (CF) will be build based on it. The CF is presented in the second session and modifications can be made to ensure acceptability for the participant. Goals for web program (WB) are set based on the CF and understanding of the factors contributing to the participant´s wellbeing. WB modules are instructed to complete during the week. Modules include psychoeducation, experiential exercises and training aimed at improving wellbeing and psychological flexibility. Web-therapist will offer written feedback. The participants can contact the therapist via the WB and al messages will be replied within one week. Automatic reminders will be sent if a participant has not been active in the WB, the therapists will call participants who have discontinued using the WB. | Behavioural | Case formulation with web-program |
Primary outcome
The 15D questionnaire (health related quality of life)
Time frame: Chance from baseline (i.e. at self-referral) to after randomisation (i.e. after clinical assessment), and to 6 and 14 weeks and to 6 and to 12 months after randomisation
The 15D is a utility-based generic, standardized measure, comprising the following 15 dimensions that describe physical, mental, and social well-being: mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. Each dimension is graded by the respondent on a scale ranging between 1 and 5, where 1 indicates an experience of no problems at all with the dimension and 5 indicates severe problems. Thus, the 15D can be used to measure a vast number of health states. We will use the 15D data both to derive 15D overall scores with values from 1 (full health) to 0 (being dead), and to obtain dimensional symptom profiles.
45 secondary outcomes
Demographic questions: age (years)
Time frame: At baseline (i.e. at self-referral)
Demographic questions: gender (male, female, prefer not to say)
Time frame: At baseline (i.e. at self-referral)
Demographic questions: marital status (Unmarried, married or cohabiting, divorced or separation, widow)
Time frame: At baseline (i.e. at self-referral)
Demographic questions: education (basic, secondary, higher)
Time frame: At baseline (i.e. at self-referral)
Demographic questions: daily exercise
Time frame: At baseline (i.e. at self-referral)
Demographic questions: Diet
Time frame: At baseline (i.e. at self-referral)
Social support and loneliness
Time frame: At baseline (i.e. at self-referral), and 12 months after randomisation
Smoking, Alcohol Use Disorders Identification Test (Audit-C)
Time frame: At baseline (i.e. at self-referral), and 12 months after randomisation
Questions about health: Self-reported health
Time frame: At baseline (i.e. at self-referral), and 12 months after randomisation
Questions about health: Self-reported diseases (diagnosed by medical doctor)
Time frame: At baseline (i.e. at self-referral), and 12 months after randomisation
Questions about health: medication
Time frame: At baseline (i.e. at self-referral), and 12 months after randomisation
Questions about health: Health care unit
Time frame: At baseline (i.e. at self-referral), and 12 months after randomisation
Questions about health: Information seeking
Time frame: At baseline (i.e. at self-referral), and 12 months after randomisation
Questions about health: height in meters
Time frame: At baseline (i.e. at self-referral)
Questions about health: weight in kilograms
Time frame: At baseline (i.e. at self-referral)
Work characteristics
Time frame: At baseline (i.e. at self-referral), and 12 months after randomisation
Symptoms related to environmental factors
Time frame: At baseline (i.e. at self-referral), and 6 and 14 weeks and 6 and 12 months after randomisation
Health worries and health worries related to environmental factors
Time frame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Environmental factors: influence on everyday life
Time frame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Resiliency (SOC-3)
Time frame: Time Frame: At baseline (i.e. at self-referral)
Personality Inventory (PK5)
Time frame: Time Frame: At baseline (i.e. at self-referral)
Questions about sleep quality, sleeping patterns
Time frame: At baseline (i.e. at self-referral), and 14 weeks, and, 6 and 12 months after randomisation
Questions about sleep quality, sleeping patterns
Time frame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Questions about sleep quality, sleeping patterns
Time frame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Questions about sleep quality, sleeping patterns
Time frame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Fatigue
Time frame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Generalized Anxiety Disorder 7 (GAD-7)
Time frame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Insomnia Severity Index (ISI)
Time frame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Patient Health Questionnaire-15 (PHQ-15)
Time frame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
The Patient Health Questionnaire (PHQ-9)
Time frame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
AIDO Healthcare app: daily mood and fatigue
Time frame: 1.5, 3.5 and 12 months after randomisation
The Acceptance and Action Questionnaire -II AAQ-7
Time frame: At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation
Comprehensive assessment of Acceptance and Commitment Therapy CompACT
Time frame: At baseline (i.e. at self-referral), and 14 weeks, 6 and 12 months after randomisation
Cognitive Fusion Questionnaire (CFQ-7)
Time frame: At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation
Whiteley index -7 questionnaire
Time frame: At baseline (i.e. at self-referral), and 14 weeks and 6 and 12 months after randomisation
White Bear Suppression Inventory (WBSI)
Time frame: At baseline (i.e. at self-referral), after randomization and 14 weeks and, 6 and 12 months after randomisation
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: At baseline (i.e. at self-referral), after randomization and 12 months after randomisation
Toronto alexithymia scale (TAS-20)
Time frame: At baseline (i.e. at self-referral)
Illness Perception Questionnaire
Time frame: At baseline (i.e. at self-referral) and 6 and 14 weeks and 6 and 12 months after randomisation
Self-assessed current ability to study or work
Time frame: At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 42449061Selinheimo S, Vuokko A, Lappalainen P, Keinonen K, Tolvanen A, Lappalainen R, Sainio M, Paunio T. The Role of Psychological Flexibility in Health-Related Quality of Life Among Patients With Persistent Physical Symptoms Associated With Indoor Environment and Chronic Fatigue - 9-Month Follow-Up of a Randomized Controlled Trial. Int J Behav Med. 2026 Jul 14. doi: 10.1007/s12529-026-10477-z. Online ahead of print.
- Derived from this study: PubMed 42033546Vuokko A, Immonen M, Lappalainen P, Keinonen K, Sainio M, Lappalainen R, Paunio T, Selinheimo S. Work Ability and Functioning Among Individuals with Persistent Indoor Environment-Related Symptoms or Chronic Fatigue: Nine-Month Follow-Up of a Web-Based Randomized Controlled Trial. J Occup Rehabil. 2026 Apr 25. doi: 10.1007/s10926-026-10400-z. Online ahead of print.
- Derived from this study: PubMed 40069901Selinheimo S, Vuokko A, Lappalainen P, Keinonen K, Sainio M, Lappalainen R, Paunio T. The association between quality of life and psychological flexibility, depressive, anxiety or insomnia symptoms in patients with persistent indoor environment-related symptoms or chronic fatigue. BMC Psychol. 2025 Mar 11;13(1):229. doi: 10.1186/s40359-025-02549-8.
- Derived from this study: PubMed 38878337Lappalainen P, Keinonen K, Lappalainen R, Selinheimo S, Vuokko A, Sainio M, Liesto S, Tolvanen A, Paunio T. Online acceptance and commitment therapy (iACT) for adults with persistent physical symptoms - 3-month follow-up study of a randomized controlled trial. J Psychosom Res. 2024 Aug;183:111830. doi: 10.1016/j.jpsychores.2024.111830. Epub 2024 Jun 13.
- Derived from this study: PubMed 36687807Selinheimo S, Keinonen K, Vuokko A, Liesto S, Sainio M, Lappalainen R, Paunio T. A randomized controlled trial protocol for persistent physical symptoms associated with indoor environment or chronic fatigue: Effectiveness of video-based functional case conceptualization and web-program for improving quality of life. Front Psychol. 2023 Jan 6;13:923532. doi: 10.3389/fpsyg.2022.923532. eCollection 2022.
- Individual participant dataSharing planned: No. All IPD that underlie results in a publication could be published But: study participants choose in informed consent that do they accept that their IPD will be published (anonymized). If they choose 'no´, their data won´t be published. Thus the preliminary plan is not to share the IPD (´undecided' would be accurate as well).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiina Paunio, Professor principal investigator
University of Helsinki, Finnish Institute of Occupational Health, the Hospital District of Helsinki and Uusimaa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case formulation with web-program in people with Persistent Physical Symptoms and Indoor Environment Associated Symptoms, run by Finnish Institute of Occupational Health at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 15D questionnaire (health related quality of life) (time frame: Chance from baseline (i.e. at self-referral) to after randomisation (i.e. after clinical assessment), and to 6 and 14 weeks and to 6 and to 12 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04532827, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.