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
IntroductionPersistent physical symptoms (PPS) refer to symptoms that cannot be fully explained by structural bodily pathology or by environmental factors. Their impact on daily functioning varies from mild to severe disability. So far, evidence-based treatments for PPS have resulted in only small t...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-01-01
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| Series: | Frontiers in Psychology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpsyg.2022.923532/full |
| _version_ | 1797959641918865408 |
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| author | Sanna Selinheimo Katariina Keinonen Aki Vuokko Sanna Liesto Markku Sainio Markku Sainio Raimo Lappalainen Tiina Paunio Tiina Paunio |
| author_facet | Sanna Selinheimo Katariina Keinonen Aki Vuokko Sanna Liesto Markku Sainio Markku Sainio Raimo Lappalainen Tiina Paunio Tiina Paunio |
| author_sort | Sanna Selinheimo |
| collection | DOAJ |
| description | IntroductionPersistent physical symptoms (PPS) refer to symptoms that cannot be fully explained by structural bodily pathology or by environmental factors. Their impact on daily functioning varies from mild to severe disability. So far, evidence-based treatments for PPS have resulted in only small to moderate effects. Treatment protocols with a stronger orientation toward personalized approaches are needed to improve the efficacy and applicability of treatment. In this study, we aim to assess the effect of an online individual case conceptualization with web-based program for PPS. This study is conducted among two focus groups: patients with indoor air-related symptoms and patients with chronic fatigue syndrome.Methods and analysesUsing a randomized controlled design (RCT) with two parallel groups in a 1:1 ratio, we will compare individual video-based case conceptualization with a web-based program based on Acceptance and Commitment Therapy (ACT), combined with treatment as usual, with treatment as usual only. The web-based program consists of ten modules, each lasting 1 week and including training. The planned sample size is 124 eligible patients without attrition. The primary outcome will be the health-related quality of life as measured by the 15D questionnaire. The secondary outcome measures will include questionnaires on psychiatric and physical symptoms, illness perceptions, psychological flexibility, and work ability. We will also use national registers to obtain information on the use of healthcare and social benefits to complete patient-reported outcomes. Data collection began in August 2020 and will continue until 2023.DiscussionThis trial will provide information on the effects and usefulness of an online administrated individual case conceptualization and an ACT-based web-program on PPS.Ethics and disseminationThe Ethics Committee of the Hospital District of Helsinki and Uusimaa, Finland, has granted approval for the study. The results will be published in peer-reviewed journals.Clinical Trial RegistrationClinicaltrials.gov, identifier NCT04532827 preresults. |
| first_indexed | 2024-04-11T00:35:37Z |
| format | Article |
| id | doaj.art-211669ff2a8b496a87fdf5c99eca7b37 |
| institution | Directory Open Access Journal |
| issn | 1664-1078 |
| language | English |
| last_indexed | 2024-04-11T00:35:37Z |
| publishDate | 2023-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychology |
| spelling | doaj.art-211669ff2a8b496a87fdf5c99eca7b372023-01-06T19:29:04ZengFrontiers Media S.A.Frontiers in Psychology1664-10782023-01-011310.3389/fpsyg.2022.923532923532A 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 lifeSanna Selinheimo0Katariina Keinonen1Aki Vuokko2Sanna Liesto3Markku Sainio4Markku Sainio5Raimo Lappalainen6Tiina Paunio7Tiina Paunio8Finnish Institute of Occupational Health, Helsinki, FinlandFinnish Institute of Occupational Health, Helsinki, FinlandFinnish Institute of Occupational Health, Helsinki, FinlandOutpatient Clinic for Functional Disorders, HUS Helsinki University Hospital, Helsinki, FinlandFinnish Institute of Occupational Health, Helsinki, FinlandOutpatient Clinic for Functional Disorders, HUS Helsinki University Hospital, Helsinki, FinlandDepartment of Psychology, University of Jyväskylä, Jyväskylä, FinlandFinnish Institute of Occupational Health, Helsinki, FinlandDepartment of Psychiatry and SleepWell Research Program, Faculty of Medicine, Helsinki University Central Hospital, University of Helsinki, Helsinki, FinlandIntroductionPersistent physical symptoms (PPS) refer to symptoms that cannot be fully explained by structural bodily pathology or by environmental factors. Their impact on daily functioning varies from mild to severe disability. So far, evidence-based treatments for PPS have resulted in only small to moderate effects. Treatment protocols with a stronger orientation toward personalized approaches are needed to improve the efficacy and applicability of treatment. In this study, we aim to assess the effect of an online individual case conceptualization with web-based program for PPS. This study is conducted among two focus groups: patients with indoor air-related symptoms and patients with chronic fatigue syndrome.Methods and analysesUsing a randomized controlled design (RCT) with two parallel groups in a 1:1 ratio, we will compare individual video-based case conceptualization with a web-based program based on Acceptance and Commitment Therapy (ACT), combined with treatment as usual, with treatment as usual only. The web-based program consists of ten modules, each lasting 1 week and including training. The planned sample size is 124 eligible patients without attrition. The primary outcome will be the health-related quality of life as measured by the 15D questionnaire. The secondary outcome measures will include questionnaires on psychiatric and physical symptoms, illness perceptions, psychological flexibility, and work ability. We will also use national registers to obtain information on the use of healthcare and social benefits to complete patient-reported outcomes. Data collection began in August 2020 and will continue until 2023.DiscussionThis trial will provide information on the effects and usefulness of an online administrated individual case conceptualization and an ACT-based web-program on PPS.Ethics and disseminationThe Ethics Committee of the Hospital District of Helsinki and Uusimaa, Finland, has granted approval for the study. The results will be published in peer-reviewed journals.Clinical Trial RegistrationClinicaltrials.gov, identifier NCT04532827 preresults.https://www.frontiersin.org/articles/10.3389/fpsyg.2022.923532/fullpersistent physical symptomsinterventioneHealthpersonalizationchronic fatigue syndromeindoor air |
| spellingShingle | Sanna Selinheimo Katariina Keinonen Aki Vuokko Sanna Liesto Markku Sainio Markku Sainio Raimo Lappalainen Tiina Paunio Tiina Paunio 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 Frontiers in Psychology persistent physical symptoms intervention eHealth personalization chronic fatigue syndrome indoor air |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | persistent physical symptoms intervention eHealth personalization chronic fatigue syndrome indoor air |
| url | https://www.frontiersin.org/articles/10.3389/fpsyg.2022.923532/full |
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