THE EFFECT OF YOGA-ASSISTED COGNITIVE BEHAVIORAL THERAPY ON INDIVIDUALS DIAGNOSED WITH GENERALIZED ANXIETY DISORDER (YOGA-CBT)
5 de maio de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
64
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: MERVE S TEKİN, RN, MSc
- Número de telefone: +905318267484
- E-mail: 2204160181003@mersin.edu.tr
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
GENERALIZED ANXIETY DISORDER SCALE
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
PSYCHOLOGICAL RESILIENCE SCALE
Prazo: 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)
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
WHO Disability Assessment Chart
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: MUALLA YILMAZ, PhD, Mersin University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de maio de 2026
Conclusão Primária (Estimado)
20 de julho de 2026
Conclusão do estudo (Estimado)
20 de setembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
27 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de maio de 2026
Primeira postagem (Real)
11 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de maio de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GAD-YOGA-CBT-2026
- 2025/38 (Outro identificador: HATAY MUSTAFA KEMAL UNIVERSITY)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
INDIVIDUAL PARTICIPANT DATA WILL NOT BE SHARED DUE TO ETHICAL CONSIDERATIONS AND CONFIDENTIALITY OF PARTICIPANTS.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .