Web-based Rehabilitation for Persistent Physical Symptoms.

Finnish Institute of Occupational Health105 enrolled

Overview

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.

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

Case formulation with web-programBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

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

One item of the frequency of the exercise on a six point likert scale (No weekly exercise - 4 times/week or more)

Time frame: 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)

Time frame: 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).

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

Five point likert scale (very poor - very good)

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

Self-reported medication during past four weeks (name, dose, purpose of use)

Time frame: 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.

Time frame: 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)

Time frame: 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

Time frame: At baseline (i.e. at self-referral)

Questions about health: weight in kilograms

weight in kilograms to calculate BMI kg/m\^2

Time frame: At baseline (i.e. at self-referral)

Work characteristics

Questions about participant work characteristics (working hours, field of industry etc)

Time frame: 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).

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

Questions about health worries in general and related to environmental factors (scale 0 not worried at all - 10 extremely worried)

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

Questions about the influence of environmental factors on everyday life (scale 0 no consequences - 10 severe consequences)

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

Length of sleep (weekdays and weekends, hours)

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

Nap (frequency per week and length, hours)

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

Self-reported i) sleep quality, ii) night awakening iii) sleep disorders and iv) frequency of sleeping medicine usage at five point likert scale.

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

Self-reported quality of rest and rhythmicity at four point likert scale.

Time frame: 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.

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

One question about current ability to study or work on a scale 1-10.

Time frame: 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)

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: after randomization and 6 and 14 weeks after randomisation

Web-based Rehabilitation for Persistent Physical Symptoms.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes