The Effectiveness of Web-based Rehabilitation for Enhancing Workability and Daily Functioning for Persistent Physical Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The 15D questionnaire (health related quality of life)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Case formulation with web-program
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.
干预措施: Case formulation with web-program (Behavioral)
Treatment as usual
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.
结局指标
主要结局
The 15D questionnaire (health related quality of life)
时间窗: 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
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.
次要结局
- Self-assessed current ability to study or work(At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation)
- Environmental factors: influence on everyday life(At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation)
- The Patient Health Questionnaire (PHQ-9)(At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation)
- Questions about sleep quality, sleeping patterns(At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation)
- Demographic questions: education (basic, secondary, higher)(At baseline (i.e. at self-referral))
- AIDO Healthcare app: daily mood and fatigue(1.5, 3.5 and 12 months after randomisation)
- 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: daily exercise(At baseline (i.e. at self-referral))
- Questions about health: Self-reported diseases (diagnosed by medical doctor)(At baseline (i.e. at self-referral), and 12 months after randomisation)
- Resiliency (SOC-3)(Time Frame: At baseline (i.e. at self-referral))
- Demographic questions: age (years)(At baseline (i.e. at self-referral))
- Demographic questions: Diet(At baseline (i.e. at self-referral))
- Social support and loneliness(At baseline (i.e. at self-referral), and 12 months after randomisation)
- Questions about health: medication(At baseline (i.e. at self-referral), and 12 months after randomisation)
- Work characteristics(At baseline (i.e. at self-referral), and 12 months after randomisation)
- Generalized Anxiety Disorder 7 (GAD-7)(At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation)
- Patient Health Questionnaire-15 (PHQ-15)(At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation)
- 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)
- Illness Perception Questionnaire(At baseline (i.e. at self-referral) and 6 and 14 weeks and 6 and 12 months after randomisation)
- Own prognosis of ability to study or work two years from now(At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation)
- Daily functioning in three sub-domains.(At baseline (i.e. at self-referral and 14 weeks and 6 and 12 months after randomisation)
- Working Alliance Inventory (WAI) - patient version for eHealth intervention(after randomization and 6 and 14 weeks after randomisation)
- Smoking, Alcohol Use Disorders Identification Test (Audit-C)(At baseline (i.e. at self-referral), and 12 months after randomisation)
- Questions about health: Self-reported health(At baseline (i.e. at self-referral), and 12 months after randomisation)
- Questions about health: Health care unit(At baseline (i.e. at self-referral), and 12 months after randomisation)
- Questions about health: height in meters(At baseline (i.e. at self-referral))
- Comprehensive assessment of Acceptance and Commitment Therapy CompACT(At baseline (i.e. at self-referral), and 14 weeks, 6 and 12 months after randomisation)
- Whiteley index -7 questionnaire(At baseline (i.e. at self-referral), and 14 weeks and 6 and 12 months after randomisation)
- Toronto alexithymia scale (TAS-20)(At baseline (i.e. at self-referral))
- Questions about health: weight in kilograms(At baseline (i.e. at self-referral))
- Symptoms related to environmental factors(At baseline (i.e. at self-referral), and 6 and 14 weeks and 6 and 12 months after randomisation)
- Questions about health: Information seeking(At baseline (i.e. at self-referral), and 12 months after randomisation)
- Health worries and health worries related to environmental factors(At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation)
- Personality Inventory (PK5)(Time Frame: At baseline (i.e. at self-referral))
- Fatigue(At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation)
- Insomnia Severity Index (ISI)(At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation)
- Cognitive Fusion Questionnaire (CFQ-7)(At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation)
- Five Facet Mindfulness Questionnaire (FFMQ)(At baseline (i.e. at self-referral), after randomization and 12 months after randomisation)
- Self-assessed stress and recovery(At baseline (i.e. at self-referral) and 14 weeks and 6 and 12 months after randomisation)
- White Bear Suppression Inventory (WBSI)(At baseline (i.e. at self-referral), after randomization and 14 weeks and, 6 and 12 months after randomisation)
- Treatment satisfaction(after randomization and 6 and 14 weeks after randomisation)
- Questions about sleep quality, sleeping patterns(At baseline (i.e. at self-referral), and 14 weeks, and, 6 and 12 months after randomisation)