Clinical trial NCT04532827: Web-based Rehabilitation for Persistent Physical Symptoms.
Official title: The Effectiveness of Web-based Rehabilitation for Enhancing Workability and Daily Functioning for Persistent Physical Symptoms.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Finnish Institute of Occupational Health
Sponsor class: OTHER
Collaborators: name: The Social Insurance Institution of Finland
name: the Hospital District of Helsinki and Uusimaa
First posted: 2020-08-31
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The 15D questionnaire (health related quality of life)
timeFrame: 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:
measure: Demographic questions: age (years)
timeFrame: At baseline (i.e. at self-referral)
measure: Demographic questions: gender (male, female, prefer not to say)
timeFrame: At baseline (i.e. at self-referral)
measure: Demographic questions: marital status (Unmarried, married or cohabiting, divorced or separation, widow)
timeFrame: At baseline (i.e. at self-referral)
measure: Demographic questions: education (basic, secondary, higher)
timeFrame: At baseline (i.e. at self-referral)
measure: Demographic questions: daily exercise
timeFrame: At baseline (i.e. at self-referral)
measure: Demographic questions: Diet
timeFrame: At baseline (i.e. at self-referral)
measure: Social support and loneliness
timeFrame: At baseline (i.e. at self-referral), and 12 months after randomisation
measure: Smoking, Alcohol Use Disorders Identification Test (Audit-C)
timeFrame: At baseline (i.e. at self-referral), and 12 months after randomisation
measure: Questions about health: Self-reported health
timeFrame: At baseline (i.e. at self-referral), and 12 months after randomisation
measure: Questions about health: Self-reported diseases (diagnosed by medical doctor)
timeFrame: At baseline (i.e. at self-referral), and 12 months after randomisation
measure: Questions about health: medication
timeFrame: At baseline (i.e. at self-referral), and 12 months after randomisation
measure: Questions about health: Health care unit
timeFrame: At baseline (i.e. at self-referral), and 12 months after randomisation
measure: Questions about health: Information seeking
timeFrame: At baseline (i.e. at self-referral), and 12 months after randomisation
measure: Questions about health: height in meters
timeFrame: At baseline (i.e. at self-referral)
measure: Questions about health: weight in kilograms
timeFrame: At baseline (i.e. at self-referral)
measure: Work characteristics
timeFrame: At baseline (i.e. at self-referral), and 12 months after randomisation
measure: Symptoms related to environmental factors
timeFrame: At baseline (i.e. at self-referral), and 6 and 14 weeks and 6 and 12 months after randomisation
measure: Health worries and health worries related to environmental factors
timeFrame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
measure: Environmental factors: influence on everyday life
timeFrame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
measure: Resiliency (SOC-3)
timeFrame: Time Frame: At baseline (i.e. at self-referral)
measure: Personality Inventory (PK5)
timeFrame: Time Frame: At baseline (i.e. at self-referral)
measure: Questions about sleep quality, sleeping patterns
timeFrame: At baseline (i.e. at self-referral), and 14 weeks, and, 6 and 12 months after randomisation
measure: Questions about sleep quality, sleeping patterns
timeFrame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
measure: Questions about sleep quality, sleeping patterns
timeFrame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
measure: Questions about sleep quality, sleeping patterns
timeFrame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
measure: Fatigue
timeFrame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
measure: Insomnia Severity Index (ISI)
timeFrame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
measure: Patient Health Questionnaire-15 (PHQ-15)
timeFrame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
measure: AIDO Healthcare app: daily mood and fatigue
timeFrame: 1.5, 3.5 and 12 months after randomisation
measure: The Acceptance and Action Questionnaire -II AAQ-7
timeFrame: At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation
measure: Comprehensive assessment of Acceptance and Commitment Therapy CompACT
timeFrame: At baseline (i.e. at self-referral), and 14 weeks, 6 and 12 months after randomisation
measure: Cognitive Fusion Questionnaire (CFQ-7)
timeFrame: At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation
measure: Whiteley index -7 questionnaire
timeFrame: At baseline (i.e. at self-referral), and 14 weeks and 6 and 12 months after randomisation
measure: White Bear Suppression Inventory (WBSI)
timeFrame: At baseline (i.e. at self-referral), after randomization and 14 weeks and, 6 and 12 months after randomisation
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: At baseline (i.e. at self-referral), after randomization and 12 months after randomisation
measure: Toronto alexithymia scale (TAS-20)
timeFrame: At baseline (i.e. at self-referral)
measure: Illness Perception Questionnaire
timeFrame: At baseline (i.e. at self-referral) and 6 and 14 weeks and 6 and 12 months after randomisation
measure: Self-assessed current ability to study or work
timeFrame: At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation
measure: Own prognosis of ability to study or work two years from now
timeFrame: At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation
measure: Self-assessed stress and recovery
timeFrame: At baseline (i.e. at self-referral) and 14 weeks and 6 and 12 months after randomisation
measure: Daily functioning in three sub-domains.
timeFrame: At baseline (i.e. at self-referral and 14 weeks and 6 and 12 months after randomisation
measure: Working Alliance Inventory (WAI) - patient version for eHealth intervention
timeFrame: after randomization and 6 and 14 weeks after randomisation
measure: Treatment satisfaction
timeFrame: after randomization and 6 and 14 weeks after randomisation
Other outcomes:
measure: Interview of treatment acceptance
timeFrame: 12 months randomisation
measure: Engagement to the intervention
timeFrame: 14 weeks after randomisation.
measure: Reasons for discontinuing
timeFrame: Through study completion, an average of 1 year
measure: The Finnish national health registers
timeFrame: At baseline (i.e. at self-referral), at 12 months after randomisation
Locations:
city: Helsinki
country: Finland
facility: Finnish Institute of Occupational Health
state: Uusimaa
Study officials:
affiliation: University of Helsinki, Finnish Institute of Occupational Health, the Hospital District of Helsinki and Uusimaa
name: Tiina Paunio, Professor
role: PRINCIPAL_INVESTIGATOR
References: