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

5 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

64

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
GENERALIZED ANXIETY DISORDER SCALE
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PSYCHOLOGICAL RESILIENCE SCALE
Periodo de tiempo: 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)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
WHO Disability Assessment Chart
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: MUALLA YILMAZ, PhD, Mersin University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de mayo de 2026

Finalización primaria (Estimado)

20 de julio de 2026

Finalización del estudio (Estimado)

20 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

27 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de mayo de 2026

Publicado por primera vez (Actual)

11 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de mayo de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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