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THE EFFECT OF YOGA-ASSISTED COGNITIVE BEHAVIORAL THERAPY ON INDIVIDUALS DIAGNOSED WITH GENERALIZED ANXIETY DISORDER (YOGA-CBT)

5. května 2026 aktualizováno: Merve Sevim TEKİN

THE EFFECT OF A YOGA-ASSISTED COGNITIVE BEHAVIORAL THERAPY-BASED ANXIETY REDUCTION PROGRAM ON PSYCHOLOGICAL RESILIENCE, FUNCTIONING, AND ANXIETY LEVELS IN INDIVIDUALS DIAGNOSED WITH GENERALIZED ANXIETY DISORDER

THIS STUDY EXAMINED 64 INDIVIDUALS WHO WERE DIAGNOSED WITH GENERALIZED ANXIETY DISORDER ACCORDING TO ICD-10 DIAGNOSTIC CRITERIA AND RECEIVED OUTPATIENT TREATMENT AT THE PSYCHIATRY POLYCLINIC OF İSKENDERUN STATE HOSPITAL BETWEEN SEPTEMBER 1, 2025, AND JULY 24, 2026, AND WHO MET THE INCLUSION AND EXCLUSION CRITERIA.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

THE INTERVENTION GROUP WILL BE ADMINISTERED A "PERSONAL INFORMATION FORM," "GENERALIZED ANXIETY DISORDER SEVERITY SCALE," "PSYCHOLOGICAL RESILIENCE SCALE," AND "WHO DISABILITY ASSESSMENT CHART" BEFORE THE PROGRAM (PRE-TEST), AND THE RESULTS WILL BE EVALUATED. THE INTERVENTION GROUP WILL RECEIVE A "YOGA-SUPPORTED COGNITIVE BEHAVIORAL THERAPY-BASED ANXIETY REDUCTION PROGRAM" FROM THE RESEARCHER OVER APPROXIMATELY 8 WEEKS, TOTALING 8 SESSIONS. THE PROGRAM INCLUDES WEEKLY INDIVIDUAL FACE-TO-FACE MEETINGS AND ONLINE GROUP YOGA SESSIONS. EACH INDIVIDUAL MEETING IS PLANNED TO LAST APPROXIMATELY 50 MINUTES. EACH GROUP YOGA SESSION WILL LAST 60 MINUTES. LITERATURE AND EXPERT OPINIONS WILL BE USED IN THE PREPARATION OF THE PROGRAM. THE INDIVIDUAL MEETING PORTION OF THE PROGRAM WILL UTILIZE COGNITIVE BEHAVIORAL THERAPY INTERVIEW PRINCIPLES, INCORPORATING TEACHING METHODS SUCH AS QUESTIONING, ATTRACTING ATTENTION, ASSIGNING HOMEWORK, AND LEARNING BY DOING. FOR THE YOGA SESSION, ACCESS TO THE INTERVENTION GROUP WILL BE VIA THE GOOGLE MEET ONLINE PLATFORM. BEFORE THE PROGRAM BEGINS, THE INTERVENTION GROUP WILL BE ADDED TO A WHATSAPP GROUP TO RECEIVE NECESSARY INFORMATION AND FEEDBACK. AT THE END OF THE PROGRAM (AFTER 8 WEEKS - POST-TEST) AND 3 MONTHS AFTER THE PROGRAM ENDS (FOLLOW-UP), THE SAME SCALES WILL BE ADMINISTERED TO INDIVIDUALS AND THE RESULTS WILL BE EVALUATED. THE CONTROL GROUP WILL BE ADMINISTERED THE "PERSONAL INFORMATION FORM", "GENERALIZED ANXIETY DISORDER SEVERITY SCALE", "PSYCHOLOGICAL RESILIENCE SCALE", AND "WHO DISABILITY ASSESSMENT CHART" AT THE SAME TIME AS THE INTERVENTION GROUP, BEFORE THE PROGRAM BEGINS (PRE-TEST), AT THE 8TH WEEK AFTER THE PROGRAM ENDS (POST-TEST), AND 3 MONTHS AFTER THE PROGRAM ENDS (FOLLOW-UP). NO APPLICATION OR TRAINING WILL BE GIVEN TO THE CONTROL GROUP. ALL DATA COLLECTION TOOLS WILL BE ADMINISTERED FACE-TO-FACE TO BOTH GROUPS.

Typ studie

Intervenční

Zápis (Odhadovaný)

64

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • VOLUNTEER TO PARTICIPATE IN THE STUDY AND HAVE GIVEN WRITTEN CONSENT
  • ACCORDING TO ICD-10 CRITERIA, HAVING BEEN DIAGNOSED WITH GENERALIZED ANXIETY DISORDER (GAD) FOR THE LAST 1 YEAR.
  • BEING BETWEEN 18 AND 60 YEARS OLD
  • KNOWING HOW TO READ AND WRITE IN TURKISH
  • LACK OF ANY ACTIVE PSYCHOTHERAPY PROCESS AND NOT ACTIVELY PRACTICING YOGA

Exclusion Criteria:

  • HAVING ANY ORGANIC DISEASE OR PSYCHOTIC ILLNESS
  • HAVING ANY SENSORY OR COGNITIVE IMPAIRMENT
  • THE PRESENCE OF ANY COMORBID PSYCHIATRIC DISORDER

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Yoga-Supported CBT İntervention Group
THE PROGRAM WILL BE PREPARED USING LITERATURE AND EXPERT OPINIONS. TEACHING METHODS SUCH AS QUESTIONING, ATTRACTING ATTENTION, ASSIGNING HOMEWORK, AND LEARNING BY DOING WILL BE UTILIZED IN THE PROGRAM CONTENT. A WHATSAPP GROUP WILL BE CREATED WITH THE INTERVENTION GROUP PARTICIPATING IN THE PROGRAM, REMINDERS WILL BE SENT, AND FEEDBACK WILL BE RECEIVED. AT THE END OF THE PROGRAM (AFTER 8 WEEKS - FINAL TEST) AND 3 MONTHS AFTER THE PROGRAM ENDS (FOLLOW-UP), THE RESULTS WILL BE EVALUATED BY APPLYING THE "PERSONAL INFORMATION FORM", "GENERALIZED ANXIETY DISORDER SEVERITY SCALE", "PSYCHOLOGICAL RESILIENCE SCALE", AND "WHO DISABILITY ASSESSMENT CHART". ALL DATA COLLECTION TOOLS WILL BE APPLIED FACE-TO-FACE. THE INTERVENTION PROGRAM WILL BE APPLIED TO 32 PATIENTS.
Behaviorální: ANXIETY REDUCTION PROGRAM
THE INTERVENTION GROUP WILL RECEIVE A "YOGA-SUPPORTED COGNITIVE BEHAVIORAL THERAPY-BASED ANXIETY REDUCTION PROGRAM" DELIVERED BY THE RESEARCHER OVER APPROXIMATELY 8 WEEKS, CONSISTING OF A TOTAL OF 8 SESSIONS. EACH SESSION WILL BE INDIVIDUAL AND FACE-TO-FACE, LASTING AN AVERAGE OF 50 MINUTES. EACH YOGA PRACTICE WILL BE CONDUCTED ONLINE AND IN A GROUP SETTING FOR 60 MINUTES. THE PROGRAM WILL BE PREPARED USING LITERATURE AND EXPERT OPINIONS. THE PROGRAM WILL UTILIZE TEACHING METHODS SUCH AS QUESTIONING, ATTRACTING ATTENTION, ASSIGNING HOMEWORK, AND LEARNING BY DOING. A WHATSAPP GROUP WILL BE CREATED WITH THE INTERVENTION GROUP PARTICIPATING IN THE PROGRAM TO PROVIDE REMINDERS AND RECEIVE FEEDBACK.
Žádný zásah: Yoga-Supported CBT Control Group
THE CONTROL GROUP WILL BE ADMINISTERED THE "PERSONAL INFORMATION FORM", "GENERALIZED ANXIETY DISORDER SEVERITY SCALE", "PSYCHOLOGICAL RESILIENCE SCALE", "WHO DISABILITY ASSESSMENT CHART" AT THE SAME TIME AS THE INTERVENTION GROUP, BEFORE THE PROGRAM STARTS (PRE-TEST), AT THE 8TH WEEK AFTER THE PROGRAM ENDS (POST-TEST) AND 3 MONTHS AFTER THE PROGRAM ENDS (FOLLOW-UP). NO INTERVENTION OR TRAINING WILL BE GIVEN TO THE CONTROL GROUP. ALL DATA COLLECTION TOOLS WILL BE ADMINISTERED FACE-TO-FACE TO 32 INDIVIDUALS.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
GENERALIZED ANXIETY DISORDER SCALE
Časové okno: Changes after the implementation compared to before implementation (weeks 8 and 20)
THIS IS A SCALE CREATED BY THE AMERICAN PSYCHIATRIC ASSOCIATION TO MEASURE AND EVALUATE THE SEVERITY OF ANXIETY DISORDERS. IT WAS TRANSLATED INTO TURKISH BY ALÇI ET AL. IN 2019, AND A VALIDITY AND RELIABILITY STUDY WAS CONDUCTED. THE SCALE IS A TEN-ITEM SELF-REPORT SCALE EXPRESSING GAD SYMPTOMS, THEIR SEVERITY, AND FREQUENCY. IT EXAMINES THE SOMATIC AND PSYCHIC SYMPTOMS OF ANXIETY. EACH ITEM IS SCORED FROM 0 TO 4, AND THE TOTAL SCORE RANGES FROM 0 TO 40. "0" MEANS NEVER, "1" MEANS OCCASIONALLY, "2" MEANS HALF THE WEEK, "3" MEANS MOST OF THE WEEK, "4" MEANS ALL THE WEEK. THE CRONBACH'S ALPHA VALUE FOR THE TOTAL SCORE IS 0.852, AND THE CORRELATION COEFFICIENTS OF THE ITEMS ARE CALCULATED BETWEEN 0.43 AND 0.68. THERE IS NO CUTOFF POINT FOR THE SCALE; IT IS ASSUMED THAT THE SEVERITY OF ANXIETY SYMPTOMS INCREASES AS THE CALCULATED TOTAL SCORE INCREASES.
Changes after the implementation compared to before implementation (weeks 8 and 20)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
PSYCHOLOGICAL RESILIENCE SCALE
Časové okno: Changes before and after the completion of the intervention (Week 8 and Week 20)
DEVELOPED BY FRANCIS AND COLLEAGUES IN 2016, THE SCALE WAS TRANSLATED INTO TURKISH BY KARAKUŞ AND AKBAY IN 2020, AND VALIDITY AND RELIABILITY STUDIES WERE CONDUCTED. THE SCALE IS CONSIDERED A LEADING INDICATOR FOR MEASURING INDIVIDUALS' PSYCHOLOGICAL RESILIENCE. IT IS A 28-ITEM, 7-POINT LIKERT-TYPE SCALE (1=STRONGLY DISAGREE, 7=STRONGLY AGREE). THE SCALE HAS 5 SUB-DIMENSIONS. THE LOWEST POSSIBLE SCORE IS 28, AND THE HIGHEST IS 196. ITEMS 2, 3, 5, 6, 8, 14, 18, 20, 22, 23, 24, AND 25 ARE SCORED IN REVERSE. HIGHER SCORES INDICATE HIGHER LEVELS OF PSYCHOLOGICAL RESILIENCE. IN THE TURKISH VALIDITY AND RELIABILITY STUDY OF THE SCALE, THE CRONBACH'S ALPHA VALUE WAS REPORTED AS 0.79 FOR THE TOTAL SCALE, 0.84 FOR THE VALUES AND VALUES-BASED BEHAVIOR SUBSCALE, 0.60 FOR THE PRESENCE IN THE MOMENT SUBSCALE, 0.72 FOR THE ACCEPTANCE SUBSCALE, 0.73 FOR THE CONTEXTUAL SELF SUBSCALE, AND 0.59 FOR THE DISSOCIATION SUBSCALE.
Changes before and after the completion of the intervention (Week 8 and Week 20)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
WHO Disability Assessment Chart
Časové okno: Changes before and after the completion of the intervention (weeks 8 and 20)
THE VALIDITY AND RELIABILITY STUDY OF THE WHODAS-II SCALE WAS COMPLETED BY ASLAN KUNT AND DEREBOY IN 2018. THE SCALE HAS BOTH LONG AND SHORT FORMS. IT IS STATED THAT THE SHORT FORM IS PREFERRED FOR CLINICAL ASSESSMENT. THE SHORT FORM IS A 12-QUESTION, 5-POINT LIKERT-TYPE SCALE (0=NO DIFFICULTY AT ALL, 4=EXTREMELY DIFFICULT/UNABLE TO DO). THE SCALE INQUIRES ABOUT THE DEGREE OF DIFFICULTY THE INDIVIDUAL EXPERIENCED DURING THE RELEVANT ACTIVITY IN THE LAST THIRTY DAYS, THROUGH QUESTIONS RELATED TO COGNITION, MOTOR SKILLS, SELF-CARE, SOCIAL INTERACTION, ACTIVITIES OF LIVING, AND SOCIAL PARTICIPATION. IT IS STATED THAT WHEN USING THE WHODAS-II SHORT FORM FOR INDIVIDUAL PATIENT ASSESSMENT, SCORES ABOVE 10 INDICATE CLINICALLY SIGNIFICANT IMPAIRMENT, AND IMPAIRMENT SCORES ARE CONSIDERED INDICATIVE OF FUNCTIONAL LOSS ACCOMPANYING PSYCHOPATHOLOGY. THE CRONBACH'S ALPHA COEFFICIENTS OF THE SCALE INDICATE THAT THE OVERALL DISABILITY SCORES OBTAINED FROM THE SHORT AND LONG FORMS ARE Α = 0.90 - 0.97
Changes before and after the completion of the intervention (weeks 8 and 20)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Merve Sevim TEKİN

Vyšetřovatelé

  • Ředitel studie: MUALLA YILMAZ, PhD, Mersin University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. května 2026

Primární dokončení (Odhadovaný)

20. července 2026

Dokončení studie (Odhadovaný)

20. září 2026

Termíny zápisu do studia

První předloženo

27. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

5. května 2026

První zveřejněno (Aktuální)

11. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. května 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • GAD-YOGA-CBT-2026
  • 2025/38 (Jiný identifikátor: HATAY MUSTAFA KEMAL UNIVERSITY)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

INDIVIDUAL PARTICIPANT DATA WILL NOT BE SHARED DUE TO ETHICAL CONSIDERATIONS AND CONFIDENTIALITY OF PARTICIPANTS.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na ANXIETY REDUCTION PROGRAM

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