Web-based Rehabilitation for Persistent Physical Symptoms.

NCT04532827 | Unknown

• 1 other identifier: 3531101
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (45)

• 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)

Other Outcomes (4)

• Interview of treatment acceptance

  12 months randomisation

• Engagement to the intervention

  14 weeks after randomisation.

• Reasons for discontinuing

  Through study completion, an average of 1 year

Study Arms (2)

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.

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.

Interventions

Case formulation with web-program BEHAVIORAL

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.

Case formulation with web-program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• B) 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Finnish Institute of Occupational Health: lead
• The Social Insurance Institution of Finland: collaborator
• the Hospital District of Helsinki and Uusimaa: collaborator

Study Sites (1)

Finnish Institute of Occupational Health

Helsinki, Uusimaa, 00270, Finland

Location

Related Publications (3)

• Selinheimo 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.

  PMID: 40069901 DERIVED

• Lappalainen 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.

  PMID: 38878337 DERIVED

• Selinheimo 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.

  PMID: 36687807 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiina Paunio, Professor

  University of Helsinki, Finnish Institute of Occupational Health, the Hospital District of Helsinki and Uusimaa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 31, 2020
• Study Start: August 18, 2020
• Primary Completion: July 1, 2023
• Study Completion: September 30, 2023
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)