THE EFFECT OF YOGA-ASSISTED COGNITIVE BEHAVIORAL THERAPY ON INDIVIDUALS DIAGNOSED WITH GENERALIZED ANXIETY DISORDER (YOGA-CBT)
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
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: MERVE S TEKİN, RN, MSc
- Numer telefonu: +905318267484
- E-mail: 2204160181003@mersin.edu.tr
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Brak interwencji: 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 mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
GENERALIZED ANXIETY DISORDER SCALE
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
PSYCHOLOGICAL RESILIENCE SCALE
Ramy czasowe: 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)
|
Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
WHO Disability Assessment Chart
Ramy czasowe: 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)
|
Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Dyrektor Studium: MUALLA YILMAZ, PhD, Mersin University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- GAD-YOGA-CBT-2026
- 2025/38 (Inny identyfikator: HATAY MUSTAFA KEMAL UNIVERSITY)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .