- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07296406
App-baseret selvstyring for Somatic Symptom Disorder og MUS: Et pilotstudie
Undersøgelse af Effektiviteten af en Applikation til Håndtering af Somatisk Symptomforstyrrelse & Medicinsk Uforklarede Symptomer (MUS): En Pilotundersøgelse
Formål Det primære formål med denne undersøgelse er at evaluere effektiviteten af en otte ugers selvstyrings-mobilapplikation for voksne, der oplever somatisk symptomforstyrrelse (SSD) eller medicinsk uforklarede symptomer (MUS). Forbedring vil blive vurderet ved hjælp af PHQ-15. Det sekundære formål er at undersøge ændringer i kliniske symptomer og fysiologiske indikatorer efter app-brug, samt at vurdere acceptabiliteten og brugbarheden af interventionen.
Videnskabelig Begrundelse Somatiske symptomer uden klar medicinsk forklaring udgør 15-30% af besøg i almen praksis (Peveler et al., 1997; Fink et al., 1999; Ko et al., 2011). Diagnostisk terminologi har udviklet sig fra somatoforme forstyrrelser i DSM-IV og MUS til SSD i DSM-5, som lægger vægt på belastende symptomer ledsaget af maladaptive tanker, følelser eller adfærd (Scott et al., 2022). SSD er ofte forbundet med alexithymi, følelsesmæssig undertrykkelse og vanskeligheder med at regulere vrede, i overensstemmelse med teorier om somatisering som den kropslige udtryksform for uforarbejdede følelser (Anuk & Bahadir, 2017; Liu et al., 2011). Disse vanskeligheder bidrager til interpersonelle funktionsnedsættelser og overdreven sundhedsplejebrug, hvilket ofte resulterer i frustration for klinikere (Orzechowska et al., 2020).
Psykologiske behandlinger, herunder CBT, MBSR, MBCT og ACT, har vist effekt i at reducere symptombelastning på tværs af tilstande som IBS, fibromyalgi, tinnitus og kronisk træthed (Hauge et al., 2015; Kikuchi et al., 2020; Roland et al., 2015). Disse terapier deler mekanismer som at forbedre krop-sind bevidsthed, reducere fysiologisk hyperarousal og fremme adaptiv håndtering og accept (Aktas et al., 2019; Jing et al., 2019). Barrierer for udbredelse eksisterer dog stadig, da patienter med SSD ofte afviser psykologiske forklaringer, praktiserer 'medical shopping' og opretholder stærke somatiske attributter (Brown, 2007; Harris et al., 2009).
Digitale interventioner tilbyder en skalerbar løsning ved at give psykoedukation om krop-sind forbindelser, CBT- og mindfulness-baserede strategier, stresshåndteringsværktøjer og adfærdsmonitorering i et tilgængeligt, dagligdags format. Evidens tyder på, at internet- og app-baserede CBT-programmer kan forbedre somatisk belastning og relaterede udfald, samtidig med at de reducerer behandlingsomkostninger og forbedrer adherence (Van et al., 2022).
Fysiologiske målinger som hjertefrekvensvariabilitet (HRV) giver en objektiv biomarkør for stressregulering. Lavere HRV afspejler reduceret modstandsdygtighed og større følelsesmæssig dysregulering, mens højere HRV indikerer overdreven arousal eller nedsat restitution. På trods af teoretiske sammenhænge mellem autonom regulering og somatisering, har få studier undersøgt HRV-responser i SSD-populationer sammen med psykologiske interventioner. Dette studie adresserer dette hul.
Studiedesign Et randomiseret kontrolleret forsøg vil rekruttere 110 voksne i alderen ≥19 år, der rapporterer betydelig somatisk belastning. Efter screening og informeret samtykke vil deltagerne blive tilfældigt tildelt (1:1) til intervention (n=55) eller kontrol (n=55) ved hjælp af en R-genereret allokeringstabel administreret uafhængigt af forskere.
Baselinevurderinger inkluderer standardiserede spørgeskemaer og HRV-måling. Interventionsgruppen vil bruge mobilapplikationen i otte uger, mens kontrolgruppen vil fortsætte sædvanlig behandling. Efter otte uger vil begge grupper gennemføre opfølgende spørgeskemaer og HRV-måling. Herefter vil interventionsgruppen afslutte app-brug, og kontrolgruppen vil blive tilbudt app-adgang. En yderligere opfølgende undersøgelse vil blive udført online for begge grupper efter 16 uger.
Forventet Indvirkning Dette studie vil give empirisk evidens for effektiviteten, brugbarheden og acceptabiliteten af en digital intervention for SSD og MUS. Ved at integrere selvstyringsstrategier med fysiologisk monitorering sigter det mod at fremme skalerbare, evidensbaserede tilgange for en befolkningsgruppe, der historisk set har været svær at behandle inden for traditionelle medicinske modeller.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Seoul, Sydkorea, 06273
- Gangnam Severance Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Voksne på 19 år eller ældre
- PHQ-15 score på 4 eller højere
- Tilstedeværelse af medicinsk uforklarede fysiske symptomer (MUS)
- Ingen væsentlig nedsættelse af læse- eller skriveevne
- Kendskab til smartphone- og internetbrug
Eksklusionskriterier:
- Nuværende diagnose af stofmisbrugsforstyrrelse (alkohol eller stoffer)
- Nuværende diagnose af skizofreni eller bipolar lidelse, eller tilstedeværelse af psykiske symptomer vurderet af klinikeren til at forstyrre deltagelse
- Modtager i øjeblikket psykoterapi specifikt for somatiske symptomer
- Diagnose af udviklingsforstyrrelser såsom autisme eller intellektuel funktionsnedsættelse, eller tegn på væsentlig kognitiv nedsættelse
- Enhver anden medicinsk tilstand vurderet af klinikeren til at gøre deltagelse uhensigtsmæssig
- Ude af stand til at fortsætte deltagelse på grund af smartphonefejl eller manglende tilstrækkelige smartphonefærdigheder
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: App Interventionsgruppe
Deltagerne i denne gruppe vil bruge den mobile selvstyringsapp til somatisk symptomatik og medicinsk uforklarede symptomer i 8 uger, udover at modtage deres sædvanlige behandling.
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Deltagere i interventionsgruppen vil bruge en mobil selvstyringsapplikation designet til personer med somatisk symptomforstyrrelse og medicinsk uforklarede symptomer.
Appen leverer psykoedukation, KBT- og mindfulness-baseret terapeutisk indhold, stresshåndteringsværktøjer og adfærdsmonitorering over en 8-ugers periode, udover deltagernes sædvanlige behandling.
Deltagerne i kontrolgruppen vil fortsætte behandlingen som sædvanligt i 8 uger uden adgang til mobilapplikationen.
Efter afslutningen af de 8-ugers primære endepunkt vil de få tilbudt adgang til mobilapplikationen.
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Ingen indgriben: Ventelistekontrolgruppe
Deltagerne i denne gruppe vil fortsætte behandlingen som sædvanligt i 8 uger uden adgang til mobilapplikationen.
Efter den primære 8-ugers periode vil de blive tilbudt adgang til applikationen.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Somatic Symptom Severity (Patient Health Questionnaire-15; PHQ-15)
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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The primary outcome is the change in somatic symptom severity measured by the Patient Health Questionnaire-15 (PHQ-15).
The PHQ-15 is a 15-item self-report scale developed to assess the severity of somatic symptoms in primary care (Kroenke et al., 1998) and validated in psychiatric outpatient populations (Han et al., 2009).
Scores range from 0 to 30, with higher scores indicating greater somatic symptom burden.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Sygdomsattitudeskala (IAS)
Tidsramme: Baseline, 8 uger efter interventionsstart og 16 uger efter interventionsstart
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Sundhedsrelaterede holdninger og bekymringer vil blive målt ved hjælp af Illness Attitudes Scale (IAS).
IAS er en 27-spørgsmål selvrapporteringsskala, der vurderer hypokondriske bekymringer, sundhedsangst, sygdomsovertalelse og relaterede sygdomsattituder.
Spørgsmålene vurderes på en skala fra 0-4, hvor højere scorer afspejler mere negative eller maladaptive holdninger og frygt relateret til sygdom.
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Baseline, 8 uger efter interventionsstart og 16 uger efter interventionsstart
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Somatic Symptom Disorder B-Criteria Scale (SSD-12)
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Somatic symptom-related cognitive, affective, and behavioral distress will be assessed using the Somatic Symptom Disorder B-Criteria Scale (SSD-12).
The SSD-12 is a 12-item self-report measure that evaluates the psychological B-criteria of somatic symptom disorder, including excessive health-related thoughts, negative emotions, and maladaptive behaviors in response to somatic symptoms.
Each item is rated on a 0-4 scale, with higher scores indicating greater somatic symptom-related psychological distress.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Depressive symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9).
The PHQ-9 is a 9-item self-report scale that assesses the frequency of core depressive symptoms over the past week, with items rated from 0 ("not at all") to 3 ("nearly every day").
Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Generalized Anxiety Disorder-7 (GAD-7)
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7).
The GAD-7 is a 7-item self-report questionnaire that measures the severity of generalized anxiety symptoms over the past week, with each item rated from 0 ("not at all") to 3 ("nearly every day").
Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Liebowitz Social Anxiety Scale, Self-Rated (LSAS-SR)
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Social anxiety symptoms will be measured using the self-rated version of the Liebowitz Social Anxiety Scale (LSAS-SR).
The LSAS-SR consists of 20 items assessing fear and avoidance across a range of social and performance situations, with each item rated on 0-4 scales for fear and avoidance.
Higher scores reflect more severe social anxiety and greater avoidance of social situations.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Korean Version of the Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Trait mindfulness will be assessed using the Korean version of the Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF).
The FFMQ-SF is a 15-item self-report scale that evaluates five facets of mindfulness: non-reactivity, observing, acting with awareness, describing, and nonjudging.
Items are rated on a 1-7 scale, with higher scores indicating higher levels of dispositional mindfulness across these facets.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Acceptance and Action Questionnaire-II (AAQ-II)
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Psychological acceptance will be measured using the Korean version of the Acceptance and Action Questionnaire-II (AAQ-II).
The AAQ-II is a self-report measure that assesses acceptance of internal experiences and willingness to act in line with values in the presence of difficult thoughts and feelings.
Items are rated on a Likert-type scale, and in the Korean scoring used in this study, higher scores indicate a higher level of acceptance and openness toward internal experiences.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Cognitive Emotion Regulation Questionnaire (CERQ)
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Cognitive emotion regulation strategies will be assessed using the Cognitive Emotion Regulation Questionnaire (CERQ).
The CERQ is a 35-item self-report measure that evaluates nine cognitive strategies used in response to negative life events, including acceptance, putting into perspective, positive refocusing, refocus on planning, positive reappraisal, self-blame, catastrophizing, other-blame, and rumination.
Items are rated on a 1-5 scale, with higher subscale scores indicating more frequent use of the corresponding cognitive emotion regulation strategy.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Intolerance of Uncertainty Scale - Short Form (IUS-12)
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Intolerance of uncertainty will be measured using the 12-item Intolerance of Uncertainty Scale - Short Form (IUS-12).
The IUS-12 assesses negative beliefs, distress, and difficulty functioning in situations involving ambiguity or uncertainty, with items rated on a 1-4 scale.
Higher scores indicate greater intolerance of uncertain or ambiguous situations.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Forms of Self-Criticism/Attacking and Self-Reassuring Scale (FSCRS)
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Self-criticism and self-reassurance will be assessed using the Korean version of the Forms of Self-Criticism/Attacking and Self-Reassuring Scale (FSCRS).
The FSCRS is an 18-item self-report measure that assesses two main dimensions: self-critical attitudes and self-reassuring responses toward oneself when facing setbacks or failures.
Items are rated on a 0-4 scale, with higher scores on self-criticism indicating more frequent self-attacking, and higher scores on self-reassurance indicating a greater ability to respond to oneself with kindness and support.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Korean Multidimensional Assessment of Interoceptive Awareness (K-MAIA)
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Interoceptive awareness will be assessed using the Korean Multidimensional Assessment of Interoceptive Awareness (K-MAIA).
The K-MAIA is a 32-item self-report scale that measures multiple dimensions of how individuals perceive and relate to internal bodily sensations, including noticing, attention regulation, emotional awareness, self-regulation, and body listening.
Items are rated on a 0-5 scale, with higher scores indicating more adaptive and accurate interoceptive awareness.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Korean Shapiro Control Inventory (K-SCI; Control and Desire for Control Subscales)
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Perceived control and desire for control will be measured using the Korean version of the Shapiro Control Inventory (K-SCI), focusing on the positive control, negative control, and desire for control subscales.
These subscales together comprise 24 items rated on a 1-7 scale and assess individuals' beliefs about their ability to exert control, their experiences of lacking control, and their motivation to maintain or increase control.
Higher scores on each subscale indicate stronger positive sense of control, greater negative control experiences, or greater desire for control, respectively.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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App Usability and Acceptability
Tidsramme: Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Perceived usability and acceptability of the mobile application will be assessed using a 24-item self-report questionnaire adapted from prior work on smartphone-based interventions for serious mental illness.
Items are rated on a three-point scale (disagree, neutral, agree) and evaluate ease of use, perceived usefulness, satisfaction, and willingness to continue using or recommend the app.
Higher scores indicate greater perceived usability, acceptability, and perceived value of the digital intervention.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 3-2024-0119
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