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Generalized Anxiety DisorderYOGA-CBTNCT07577271

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

A study testing ANXIETY REDUCTION PROGRAM in people with Generalized Anxiety Disorder, run by Merve Sevim TEKİN.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Generalized Anxiety Disorder
What is being tested?
ANXIETY REDUCTION PROGRAM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
No sites listed yet
Study dates
15 May 2026to 20 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

MERVE S TEKİN, RN, MSc contact

+905318267484

2204160181003@mersin.edu.tr

About this study

Official title: 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.

Read the detailed description

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.

Being tested
ANXIETY REDUCTION PROGRAM
Medical subject headings
Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANXIETY REDUCTION PROGRAMBehavioural

    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.

Study groups in NCT07577271
Study groupRoleWhat they receive
Yoga-Supported CBT İntervention GroupExperimentalTHE 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.
Receives: Behavioral: ANXIETY REDUCTION PROGRAM
Yoga-Supported CBT Control GroupNo interventionTHE 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Changes after the implementation compared to before implementation (weeks 8 and 20)

Secondary outcomes (1)
  1. PSYCHOLOGICAL RESILIENCE SCALE

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2026
  2. Study start15 May 2026 (estimated)
  3. Primary completion20 Jul 2026 (estimated)
  4. Study completion20 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07577271
Sponsor's protocol ID
GAD-YOGA-CBT-2026
Other IDs
2025/38
Acronym
YOGA-CBT
Status last verified
Apr 2026
First submitted
27 Apr 2026
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: INDIVIDUAL PARTICIPANT DATA WILL NOT BE SHARED DUE TO ETHICAL CONSIDERATIONS AND CONFIDENTIALITY OF PARTICIPANTS.

Questions about this trial

What is this clinical trial studying?

A study testing ANXIETY REDUCTION PROGRAM in people with Generalized Anxiety Disorder, run by Merve Sevim TEKİN.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MERVE S TEKİN, RN, MSc (+905318267484, 2204160181003@mersin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GENERALIZED ANXIETY DISORDER SCALE (time frame: Changes after the implementation compared to before implementation (weeks 8 and 20)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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