Web-based Rehabilitation for Persistent Physical Symptoms.

NCT04532827 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-01-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • The Social Insurance Institution of Finland

    collaborator UNKNOWN
  • the Hospital District of Helsinki and Uusimaa

    collaborator UNKNOWN
  • Finnish Institute of Occupational Health

    lead OTHER

Principal Investigators

  • Tiina Paunio, Professor · University of Helsinki, Finnish Institute of Occupational Health, the Hospital District of Helsinki and Uusimaa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2023-07-01
Completion
2023-09-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04532827 on ClinicalTrials.gov