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Tilpasning af individuel dialektisk adfærdsterapiintervention til transdiagnostisk behandling af følelsesmæssige lidelser

27. maj 2026 opdateret af: Shen-Ing,Liu, Mackay Memorial Hospital

Tilpasning af individuel dialektisk adfærdsterapiintervention til transdiagnostisk behandling af følelsesmæssige lidelser i to medicinske centre: et randomiseret kontrolleret forsøg

Angst og depressive lidelser, kaldet følelsesmæssige lidelser, har høje forekomster, tilbagefald og funktionsnedsættelse. Transdiagnostisk psykoterapi rettet mod fælles træk ved disse lidelser er for nylig dukket op. Dialektisk adfærdsterapi (DBT) til transdiagnostisk behandling af følelsesmæssige lidelser er en lovende tilgang, da resultater af foreløbige undersøgelser til brug ved en bred vifte af psykiske lidelser er opmuntrende. Da der er mangel på forskning i transdiagnostisk psykoterapi i Taiwan, foreslår efterforskerne således dette 3-årige randomiserede kontrollerede forsøg for at teste effektiviteten af ​​en modificeret DBT til behandling af transdiagnostiske følelsesmæssige lidelser og for yderligere at evaluere, om effektiviteten af ​​modificeret DBT er forskellig. i de specifikke følelsesmæssige lidelser. Efterforskerne forventer, at patienter med følelsesmæssige lidelser, der modtager modificeret DBT, er mere tilbøjelige til at forbedre kliniske resultater, funktion og livskvalitet.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Angst og depressive lidelser, kaldet følelsesmæssige lidelser, har høje forekomster, tilbagefald og funktionsnedsættelse. Transdiagnostisk psykoterapi rettet mod fælles træk ved disse lidelser er for nylig dukket op. Dialektisk adfærdsterapi (DBT) til transdiagnostisk behandling af følelsesmæssige lidelser er en lovende tilgang, da resultater af foreløbige undersøgelser til brug ved en bred vifte af psykiske lidelser er opmuntrende. Da der er mangel på forskning i transdiagnostisk psykoterapi i Taiwan, foreslår efterforskerne således dette 3-årige randomiserede kontrollerede forsøg for at teste effektiviteten af ​​en modificeret DBT til behandling af transdiagnostiske følelsesmæssige lidelser og for yderligere at evaluere, om effektiviteten af ​​modificeret DBT er forskellig. i de specifikke følelsesmæssige lidelser. Dette 3-årige interventionsforsøg har et randomiseret, kontrolleret, to-center og enkelt-blindet design med to parallelle grupper. Forsøget vil blive gennemført på de psykiatriske afdelinger på to medicinske centre med identiske protokoller. Deltagerne vil blive rekrutteret og tilfældigt allokeret 1:1 til en af ​​to undersøgelsesarme. Den modificerede DBT-protokol i et individuelt terapiformat består af 12 ugentlige individuelle sessioner, som hver varer 50 minutter. Mindst 250 deltagere vil blive inkluderet baseret på estimeret stikprøvestørrelse. Bedømmelser vil finde sted før forsøgets start, ved forsøgets afslutning og ved en 3-måneders opfølgning. Primære resultater vil være sværhedsgraden af ​​depression og angst, vurderet af blinde bedømmere. Sekundære resultater omfatter lidelsesspecifikke symptomer, lidelsens sværhedsgrad, funktionsnedsættelse, livskvalitet og følelsesreguleringsforstyrrelser. Efterforskerne vil også undersøge behandlingsmekanismerne og behandlingsforløbene.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

250

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Hui-Chun Huang, Ph.D
  • Telefonnummer: 3055 886-2-28094661
  • E-mail: aihch@mmh.org.tw

Studiesteder

  • Taiwan
      • Taipei, Taiwan
        • Rekruttering
        • Mackay Memorial Hospital
        • Kontakt:
          • Hui-Chun Huang, Ph.D
          • Telefonnummer: 3055 886228094661
          • E-mail: aihch@mmh.org.tw

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Mandarin kinesisk sprogfærdighed tilstrækkelig til at udfylde undersøgelsesspørgeskemaet
  2. En aktuel diagnose af depressiv eller angstlidelse som diagnosticeret fra et SCAN-interview

Ekskluderingskriterier:

  1. Intellektuel handicap
  2. Stofmisbrug inden for de seneste tre måneder
  3. Maniodepressiv
  4. Psykotisk lidelse
  5. Organisk hjernesygdom
  6. Akut suicidalitet eller en historie med hyppige eller nylige selvmordsforsøg
  7. Nylig (seneste seks uger) ændring i psykiatrisk medicin eller manglende vilje til at opretholde en stabil dosis af medicin under studiedeltagelse
  8. Havde modtaget fem eller flere sessioner med CBT i de sidste fem år eller uvillig til at stoppe samtidig psykoterapi for en følelsesmæssig lidelse
  9. Enhver psykisk eller fysisk tilstand, der kræver hospitalsindlæggelse
  10. En anden medicinsk tilstand vil sandsynligvis forhindre deltagelse i undersøgelsen

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Behandling som sædvanlig (TAU)
Treatment-as-usual (TAU) er en naturalistisk behandlingstilstand, som leveres i den nuværende daglige praksis af psykiatere i medicinske tjenester i Taiwan. TAU omfatter typisk ordination og overvågning af antidepressiv og/eller angstdæmpende medicin, psykologisk behandling (dette kan omfatte empatisk lytning og/eller støttende rådgivning, psykoedukation osv.) eller en kombination af begge. Patienter i TAU-tilstanden, der allerede modtager nogen af ​​de førnævnte behandlinger, informeres om, at de vil fortsætte med som sædvanligt at modtage de ydelser, der blev modtaget før tilmelding til undersøgelsen.
Eksperimentel: Transdiagnostic Adapted DBT plus TAU
The modified DBT protocol, developed by the principal investigator and co-investigators, which will be offered in an individual therapy format. It consists of 15 weekly individual sessions, each lasting 50-60 minutes. It is made based on the manual (Linehan 2015), retaining the essence of DBT (Linehan 1993), and remain dialectically focused. Each session focuses on specific skills within that content of modules.
Adfærdsmæssigt: Dialectical behavior therapy (DBT)
The modified DBT protocol, developed by the principal investigator and co-investigators, will be offered in an individual therapy format. It consists of 15 weekly individual sessions, each lasting 50-60 minutes. It is made based on the manual, retaining the essence of DBT and remaining dialectically focused. Each session focuses on specific skills within the context of modules.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of total score of Hamilton Depression Scale-17 item (HAMD-17)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Hamilton Depression Scale-17 item is an interview-based instrument for rating the overall levels of severity of the symptoms of depression and the response to treatment. Each item is rated from 0 to 4 or 0 to 2; the scores correspond to increases in severity. Total scores range from 0 to 52.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of Hamilton Anxiety Scale (HAM-A)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
HAM-A comprises 14 items with each item being divided into five grades, based on a scale of 0 to 4, with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
CGI-S (severity): the current condition of the patient on a scale of 1-7 (1 being normal, and 7 being among the most severely ill patients). CGI-I (improvement): the degree of improvement, as perceived by the clinician, since the start of treatment of a scale of 1-7, 1 being very much improved, and 7 being very much worse.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of total score of Depression, Anxiety, and Stress Scales (DASS-21)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
DASS-21 is a self-report measure of depression, anxiety and stress. Each seven-item scale has four response options ranging from 0 (do not apply to me at all) to 3 (apply to me much, or most of the time). Higher scores on each scale indicate higher depression, anxiety, and distress.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of Patient Health Questionnaire-9 items (PHQ-9)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
PHQ-9 is a nine-item self-rated questionnaire to measure the severity of depressive symptoms corresponding to the DSM-V criteria of MDD. Each item of the PHQ-9 requires a response on a 4-point scale, ranging from 0 (never) to 3 (nearly everyday), for a total score ranging from 0 to 27, with higher scores indicating increased likelihood for major depressive disorder.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of Generalized Anxiety Disorder-7 items (GAD-7)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
GAD-7 is a seven-item self-rated questionnaire to assess the severity of generalized anxiety disorder according to DSM-IV diagnostic criteria. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of Panic Disorder Severity Scale- Self Rating (PDSS-SR)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
PDSS-SR is a self-reported instrument to rate the overall severity of panic disorder. It consists of 7 items coded on a 5-point ordinal scale (0-4), with higher scores indicating a more severe panic attack.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of Penn State Worry Questionnaire (PSWQ)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
PSWQ has been widely used as a self-report measure of worry and GAD in most treatment outcome studies of GAD. It has 16 items and each item is rated on a scale from 1 ('not at all typical of me') to 5 ('very typical of me'). Total score indicate greater levels of pathological worry.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of Short Form Social Interaction Anxiety (SIAS)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
The Social Interaction Anxiety Scale (SIAS) is companion measures developed for social anxiety. It is among the most commonly used tool for assessing social anxiety and the outcome of psychosocial therapy. Short-form SIAS is the self-report scale with items rated on a 5-point Likert-type scale with values ranging from 0 "Not at all characteristic or true of me" to 4 "Extremely characteristic or true of me". Higher scores indicate more severe social anxiety.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of Short Form Social Phobia Scale (SPS)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
The Social Phobia Scale (SPS) is companion measures developed for social anxiety. It is among the most commonly used tool for assessing social anxiety and the outcome of psychosocial therapy. Short-form SPS is the self-report scale with items rated on a 5-point Likert-type scale with values ranging from 0 "Not at all characteristic or true of me" to 4 "Extremely characteristic or true of me". Higher scores indicate more severe social anxiety.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of Difficulties in Emotional Regulation Scale (DERS)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
DERS including 36 items which assess difficulties regulating emotion across six domains, will be used to assess emotional dysregulation. Items are rated on a scale of 1 ("almost never ") to 5 ("almost always"). Higher scores indicate more difficulty in emotion regulation.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of International Positive and Negative Affect Schedule-Short Form (PANAS-SF)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
The 10-item I-PANAS-SF includes five items measuring positive affect (PA) and five items measuring negative affect (NA). Responses were provided on a 5-point Likert scale ranging from 1 (never) to 5 (always). The higher scores on both PA and NA items indicate the tendency to experience a positive and negative mood.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
It evaluates overall enjoyment and satisfaction with physical health, mood, work, household and leisure activities, social and family relationships, daily functioning, sexual life, economic status, overall well-being, and medications. Items are rated on a 5-point scale ('not at all or never' to 'frequently or all the time'), with higher scores indicating better enjoyment and satisfaction with life.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of The Work and Social Adjustment Scale (WSAS)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
WSAS was developed to measure the functional impairment resulting from a health problem. Each item is rated on a 9-point Likert scale from 0 (no impairment) to 8 (very severe impaired). Total scores range from 0 to 40; scores of <10 indicate a subclinical condition, 10 to 20 significant functional impairment but less severe clinical symptomatology, and ≥20 moderately severe psychopathology.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of skills subscale (DSS) of the DBT Ways of Coping Checklist (DBT-WCCL)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
DBT Skills Subscale (DSS; 38 items), which assesses adaptive coping responses. Participants rate how often they have used each strategy in the past month using a 4-point Likert-type scale from 0 (never used) to 3 (regularly used).Higher scores indicate more frequent use of these skills.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Change of total score of the Five Facet Mindfulness Questionnaire (FFMQ)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
The FFMQ measures five aspects of mindfulness: observing, describing, acting with awareness, nonjudging of internal experience, and nonreactivity to internal experience.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of diagnosis of Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Schedules for Clinical Assessment in Neuropsychiatry (SCAN), a semi-structured clinical interview with high reliability, is used to assess Axis I disorders. Diagnoses are assigned a clinical severity rating with a score of 0 (no symptoms attaining clinically significant severity) to 4 (severe interfering or disturbing in daily activity) as the clinical threshold for diagnostic criteria.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
List of threatening experiences (LTE)
Tidsramme: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
The LTE questionnaire consists of 12 questions with dichotomous responses (i.e., yes/no) regarding the occurrence of 12 prevalent major stressful events.
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
Treatment History Interview -B (THI-B)
Tidsramme: Posttreatment (20 weeks)
The THI-B is used to assess patients' experiences with the psychological treatments they received during the study.
Posttreatment (20 weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mackay Memorial Hospital

Samarbejdspartnere

National Science and Technology Council

Efterforskere

  • Ledende efterforsker: Shen-Ing Liu, Ph.D, Mackay Memorial Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2023

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

13. juli 2023

Først indsendt, der opfyldte QC-kriterier

9. august 2023

Først opslået (Faktiske)

14. august 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. oktober 2025

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 112-2314-B-195 -007 -MY3

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