Web-based Rehabilitation for Persistent Physical Symptoms. (DigiPimo)

Finnish Institute of Occupational Health

Status: Active, not recruiting

Conditions: Persistent Physical Symptoms; Indoor Air Associated Symptoms; Chronic Fatigue Syndrome; Indoor Environment Associated Symptoms

Treatments: Behavioral: Case formulation with web-program

Study type: Interventional

Funder types: Other

Identifiers

NCT04532827

3531101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 2 patient groups

Case formulation with web-program

Experimental group

Description:

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.

Treatment:

Behavioral: Case formulation with web-program

Treatment as usual

No Intervention group

Description:

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.