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

NCT07577271 | Not Yet Recruiting DMC

• 2 other identifiers: GAD-YOGA-CBT-20262025/38
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• GENERALIZED ANXIETY DISORDER SCALE

  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)

Secondary Outcomes (1)

• PSYCHOLOGICAL RESILIENCE SCALE

  Changes before and after the completion of the intervention (Week 8 and Week 20)

Other Outcomes (1)

• WHO Disability Assessment Chart

  Changes before and after the completion of the intervention (weeks 8 and 20)

Study Arms (2)

Yoga-Supported CBT İntervention Group

EXPERIMENTAL

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.

Behavioral: ANXIETY REDUCTION PROGRAM

Yoga-Supported CBT Control Group

NO INTERVENTION

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.

Interventions

ANXIETY REDUCTION PROGRAM BEHAVIORAL

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.

Yoga-Supported CBT İntervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Merve Sevim TEKİN: lead

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• MUALLA YILMAZ, PhD

  Mersin University

  STUDY DIRECTOR

Central Study Contacts

MERVE S TEKİN, RN, MSc

CONTACT

+905318267484; 2204160181003@mersin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: PATIENTS WITH GENERALIZED ANXIETY DISORDER IN THE EXPERIMENTAL AND CONTROL GROUPS WILL BE MASKED.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: SPECIALIST NURSE

Model Details: THE STUDY WAS PLANNED AS A PROSPECTIVE, TWO-ARMED (1:1), RANDOMIZED CONTROLLED EXPERIMENTAL STUDY. THIS RANDOMIZED CONTROLLED TRIAL WILL BE REPORTED ACCORDING TO THE CONSORT GUIDELINES.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 11, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share