Chronic Fatigue Syndrome, Indoor Air Associated Symptoms, Indoor Environment Associated Symptoms, Persistent Physical Symptoms
Conditions
Keywords
Indoor air, Persistent physical symptoms, Chronic Fatigue Syndrome, Web-based intervention, Rehabilitation, Indoor environment, EHealth
Brief 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 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.
Interventions
BEHAVIORALCase formulation with web-program
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.
Sponsors
The Social Insurance Institution of Finland
the Hospital District of Helsinki and Uusimaa
Finnish Institute of Occupational Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The randomization will be pre-programmed and the allocation sequence will be carried out and concealed by a researcher who is not otherwise involved in trial at FIOH. This study compares eHealth intervention with treatment as usual. Thus it is not possible to blind the study participants. However, eHealth therapists are blinded for study participant compared with patients in eHealth intervention for other reasons, I.e. study participants and patients referred to the program as treatment as usual by their physician. Further, data analyst will be blinded to intervention arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 A) Indoor air-related symptoms 1. 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. 2. 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) or B) Chronic fatigue 1. Post-exertional malaise and/ or post-exertional fatigue. 2. Unrefreshing sleep or disturbance of sleep quantity or rhythm disturbance. 3. 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.
Exclusion criteria
* 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 1. 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) 2. Psychiatric disorder (bipolar disorder, psychotic disorders, alcohol and/or drug dependency or abuse, eating disorders, and/or severe mood disorders) 3. Developmental disorders * Current psychotherapy * Other Patient refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The 15D questionnaire (health related quality of life) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Own prognosis of ability to study or work two years from now | At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation | One question about of work ability two years from now (scale Unlikely; Not certain; Relatively certain) |
| Self-assessed stress and recovery | At baseline (i.e. at self-referral) and 14 weeks and 6 and 12 months after randomisation | One question about stress and recovery on a scale 1-10. |
| Daily functioning in three sub-domains. | At baseline (i.e. at self-referral and 14 weeks and 6 and 12 months after randomisation | Three questions about daily functioning (work, social life, home) on a scale 1-10 each |
| Working Alliance Inventory (WAI) - patient version for eHealth intervention | after randomization and 6 and 14 weeks after randomisation | — |
| Treatment satisfaction | after randomization and 6 and 14 weeks after randomisation | Six items of treatment satisfaction based on Seligman´s report (1995). The effectiveness of psychotherapy: The Consumer Reports study. American psychologist, 50(12), 965. |
| Demographic questions: age (years) | At baseline (i.e. at self-referral) | — |
| Demographic questions: gender (male, female, prefer not to say) | At baseline (i.e. at self-referral) | — |
| Demographic questions: marital status (Unmarried, married or cohabiting, divorced or separation, widow) | At baseline (i.e. at self-referral) | — |
| Demographic questions: education (basic, secondary, higher) | At baseline (i.e. at self-referral) | — |
| Demographic questions: daily exercise | At baseline (i.e. at self-referral) | One item of the frequency of the exercise on a six point likert scale (No weekly exercise - 4 times/week or more) |
| Demographic questions: Diet | At baseline (i.e. at self-referral) | 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) |
| Social support and loneliness | At baseline (i.e. at self-referral), and 12 months after randomisation | Five questions of frequency of perceived loneliness and and social support in challenging situations (likert scale). |
| Smoking, Alcohol Use Disorders Identification Test (Audit-C) | At baseline (i.e. at self-referral), and 12 months after randomisation | — |
| Questions about health: Self-reported health | At baseline (i.e. at self-referral), and 12 months after randomisation | Five point likert scale (very poor - very good) |
| Questions about health: Self-reported diseases (diagnosed by medical doctor) | At baseline (i.e. at self-referral), and 12 months after randomisation | — |
| Questions about health: medication | At baseline (i.e. at self-referral), and 12 months after randomisation | Self-reported medication during past four weeks (name, dose, purpose of use) |
| Questions about health: Health care unit | At baseline (i.e. at self-referral), and 12 months after randomisation | An open question of the participant´s health care provider. |
| Questions about health: Information seeking | At baseline (i.e. at self-referral), and 12 months after randomisation | Questions about health information seeking from different sources (on a six point likert scale) |
| Questions about health: height in meters | At baseline (i.e. at self-referral) | height in meters to calculate BMI kg/m\^2 |
| Questions about health: weight in kilograms | At baseline (i.e. at self-referral) | weight in kilograms to calculate BMI kg/m\^2 |
| Work characteristics | At baseline (i.e. at self-referral), and 12 months after randomisation | Questions about participant work characteristics (working hours, field of industry etc) |
| Symptoms related to environmental factors | At baseline (i.e. at self-referral), and 6 and 14 weeks and 6 and 12 months after randomisation | 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). |
| Health worries and health worries related to environmental factors | At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation | Questions about health worries in general and related to environmental factors (scale 0 not worried at all - 10 extremely worried) |
| Environmental factors: influence on everyday life | At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation | Questions about the influence of environmental factors on everyday life (scale 0 no consequences - 10 severe consequences) |
| Resiliency (SOC-3) | Time Frame: At baseline (i.e. at self-referral) | — |
| Personality Inventory (PK5) | Time Frame: At baseline (i.e. at self-referral) | — |
| Questions about sleep quality, sleeping patterns | At baseline (i.e. at self-referral), and 14 weeks, and, 6 and 12 months after randomisation | Length of sleep (weekdays and weekends, hours) |
| Fatigue | At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation | Questionnaire about perceived fatigue and its´consequences on daily functioning during past six months. |
| Generalized Anxiety Disorder 7 (GAD-7) | At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation | — |
| Insomnia Severity Index (ISI) | At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation | — |
| Patient Health Questionnaire-15 (PHQ-15) | At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation | — |
| The Patient Health Questionnaire (PHQ-9) | At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation | — |
| AIDO Healthcare app: daily mood and fatigue | 1.5, 3.5 and 12 months after randomisation | — |
| The Acceptance and Action Questionnaire -II AAQ-7 | 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 | At baseline (i.e. at self-referral), and 14 weeks, 6 and 12 months after randomisation | — |
| Cognitive Fusion Questionnaire (CFQ-7) | At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation | — |
| Whiteley index -7 questionnaire | At baseline (i.e. at self-referral), and 14 weeks and 6 and 12 months after randomisation | — |
| White Bear Suppression Inventory (WBSI) | At baseline (i.e. at self-referral), after randomization and 14 weeks and, 6 and 12 months after randomisation | — |
| Five Facet Mindfulness Questionnaire (FFMQ) | At baseline (i.e. at self-referral), after randomization and 12 months after randomisation | — |
| Toronto alexithymia scale (TAS-20) | At baseline (i.e. at self-referral) | — |
| Illness Perception Questionnaire | 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 | At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation | One question about current ability to study or work on a scale 1-10. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reasons for discontinuing | Through study completion, an average of 1 year | If participant discontinues he / she will be contacted. |
| The Finnish national health registers | At baseline (i.e. at self-referral), at 12 months after randomisation | The Finnish national health registers to assess health care expenditures: Data on outpatient visits (AvoHILMO data), data on inpatient care (HILMO data), data on occupational health care use, information on prescribed and reimbursed prescription medicines purchases, information on rights for special reimbursement for medicines and information on sickness and disability benefits and rehabilitation with diagnoses |
| Engagement to the intervention | 14 weeks after randomisation. | Total number of logins and time during the web-program, modules and exercises completed. |
| Interview of treatment acceptance | 12 months randomisation | Interview for sample of intervention participants about the treatment acceptance (qualitative) |
Countries
Finland
Outcome results
None listed