Web-based Rehabilitation for Persistent Physical Symptoms.

Chronic Fatigue Syndrome Clinical Trial

— DigiPimo  

Official title:

The Effectiveness of Web-based Rehabilitation for Enhancing Workability and Daily Functioning for Persistent Physical Symptoms.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04532827
• Other study ID #: 3531101
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2023
• Source: Finnish Institute of Occupational Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: September 30, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Indoor Air Associated Symptoms
• Indoor Environment Associated Symptoms
• Persistent Physical Symptoms

Intervention

Behavioral:
• Case 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.

Locations

Country	Name	City	State
Finland	Finnish Institute of Occupational Health	Helsinki	Uusimaa

Sponsors (3)

Lead Sponsor	Collaborator
Finnish Institute of Occupational Health	the Hospital District of Helsinki and Uusimaa, The Social Insurance Institution of Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interview of treatment acceptance	Interview for sample of intervention participants about the treatment acceptance (qualitative)	12 months randomisation
Other	Engagement to the intervention	Total number of logins and time during the web-program, modules and exercises completed.	14 weeks after randomisation.
Other	Reasons for discontinuing	If participant discontinues he / she will be contacted.	Through study completion, an average of 1 year
Other	The Finnish national health registers	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	At baseline (i.e. at self-referral), at 12 months after randomisation
Primary	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.	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	Demographic questions: age (years)		At baseline (i.e. at self-referral)
Secondary	Demographic questions: gender (male, female, prefer not to say)		At baseline (i.e. at self-referral)
Secondary	Demographic questions: marital status (Unmarried, married or cohabiting, divorced or separation, widow)		At baseline (i.e. at self-referral)
Secondary	Demographic questions: education (basic, secondary, higher)		At baseline (i.e. at self-referral)
Secondary	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)	At baseline (i.e. at self-referral)
Secondary	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)	At baseline (i.e. at self-referral)
Secondary	Social support and loneliness	Five questions of frequency of perceived loneliness and and social support in challenging situations (likert scale).	At baseline (i.e. at self-referral), and 12 months after randomisation
Secondary	Smoking, Alcohol Use Disorders Identification Test (Audit-C)		At baseline (i.e. at self-referral), and 12 months after randomisation
Secondary	Questions about health: Self-reported health	Five point likert scale (very poor - very good)	At baseline (i.e. at self-referral), and 12 months after randomisation
Secondary	Questions about health: Self-reported diseases (diagnosed by medical doctor)		At baseline (i.e. at self-referral), and 12 months after randomisation
Secondary	Questions about health: medication	Self-reported medication during past four weeks (name, dose, purpose of use)	At baseline (i.e. at self-referral), and 12 months after randomisation
Secondary	Questions about health: Health care unit	An open question of the participant´s health care provider.	At baseline (i.e. at self-referral), and 12 months after randomisation
Secondary	Questions about health: Information seeking	Questions about health information seeking from different sources (on a six point likert scale)	At baseline (i.e. at self-referral), and 12 months after randomisation
Secondary	Questions about health: height in meters	height in meters to calculate BMI kg/m^2	At baseline (i.e. at self-referral)
Secondary	Questions about health: weight in kilograms	weight in kilograms to calculate BMI kg/m^2	At baseline (i.e. at self-referral)
Secondary	Work characteristics	Questions about participant work characteristics (working hours, field of industry etc)	At baseline (i.e. at self-referral), and 12 months after randomisation
Secondary	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).	At baseline (i.e. at self-referral), and 6 and 14 weeks and 6 and 12 months after randomisation
Secondary	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)	At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Secondary	Environmental factors: influence on everyday life	Questions about the influence of environmental factors on everyday life (scale 0 no consequences - 10 severe consequences)	At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Secondary	Resiliency (SOC-3)		Time Frame: At baseline (i.e. at self-referral)
Secondary	Personality Inventory (PK5)		Time Frame: At baseline (i.e. at self-referral)
Secondary	Questions about sleep quality, sleeping patterns	Length of sleep (weekdays and weekends, hours)	At baseline (i.e. at self-referral), and 14 weeks, and, 6 and 12 months after randomisation
Secondary	Questions about sleep quality, sleeping patterns	Nap (frequency per week and length, hours)	At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Secondary	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.	At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Secondary	Questions about sleep quality, sleeping patterns	Self-reported quality of rest and rhythmicity at four point likert scale.	At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Secondary	Fatigue	Questionnaire about perceived fatigue and its´consequences on daily functioning during past six months.	At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Secondary	Generalized Anxiety Disorder 7 (GAD-7)		At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Secondary	Insomnia Severity Index (ISI)		At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Secondary	Patient Health Questionnaire-15 (PHQ-15)		At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Secondary	The Patient Health Questionnaire (PHQ-9)		At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation
Secondary	AIDO Healthcare app: daily mood and fatigue		1.5, 3.5 and 12 months after randomisation
Secondary	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
Secondary	Comprehensive assessment of Acceptance and Commitment Therapy CompACT		At baseline (i.e. at self-referral), and 14 weeks, 6 and 12 months after randomisation
Secondary	Cognitive Fusion Questionnaire (CFQ-7)		At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation
Secondary	Whiteley index -7 questionnaire		At baseline (i.e. at self-referral), and 14 weeks and 6 and 12 months after randomisation
Secondary	White Bear Suppression Inventory (WBSI)		At baseline (i.e. at self-referral), after randomization and 14 weeks and, 6 and 12 months after randomisation
Secondary	Five Facet Mindfulness Questionnaire (FFMQ)		At baseline (i.e. at self-referral), after randomization and 12 months after randomisation
Secondary	Toronto alexithymia scale (TAS-20)		At baseline (i.e. at self-referral)
Secondary	Illness Perception Questionnaire		At baseline (i.e. at self-referral) and 6 and 14 weeks and 6 and 12 months after randomisation
Secondary	Self-assessed current ability to study or work	One question about current ability to study or work on a scale 1-10.	At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation
Secondary	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)	At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation
Secondary	Self-assessed stress and recovery	One question about stress and recovery on a scale 1-10.	At baseline (i.e. at self-referral) and 14 weeks and 6 and 12 months after randomisation
Secondary	Daily functioning in three sub-domains.	Three questions about daily functioning (work, social life, home) on a scale 1-10 each	At baseline (i.e. at self-referral and 14 weeks and 6 and 12 months after randomisation
Secondary	Working Alliance Inventory (WAI) - patient version for eHealth intervention		after randomization and 6 and 14 weeks after randomisation
Secondary	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.	after randomization and 6 and 14 weeks after randomisation