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

5 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

64

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
GENERALIZED ANXIETY DISORDER SCALE
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PSYCHOLOGICAL RESILIENCE SCALE
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
WHO Disability Assessment Chart
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Merve Sevim TEKİN

Investigatori

  • Direttore dello studio: MUALLA YILMAZ, PhD, Mersin University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 maggio 2026

Completamento primario (Stimato)

20 luglio 2026

Completamento dello studio (Stimato)

20 settembre 2026

Date di iscrizione allo studio

Primo inviato

27 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

11 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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