- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07334769
Religiously Integrated Cognitive Behavioral Therapy
Religiously Integrated Cognitive Behavioral Group Therapy for Generalized Anxiety Disorder
This study aims to examine the effect of a newly developed religously oriented cognitive behavioral group therapy program on the level of anxiety and well-being in young adults compared to the traditional cognitive behavioral therapy-based program.
Hypoteses 1 Religiously oriented CBT group therapy will be more effective in reducing participants' general anxiety levels compared to traditional CBT group therapy and the control group, and this effect will continue in the two-month follow-up measurements.
Hypoteses 2 Religiously oriented CBT group therapy will be more effective in increasing participants' levels of well-being compared to traditional CBT group therapy and the control group, and this effect will continue in the two-month follow-up measurements.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Türkiye
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Istanbul, Türkiye, Turkey (Türkiye), 34000
- İstanbul
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Being between 18 and 45 years of age, Willingness to participate in 10 weekly group sessions, Having a GAD-7 score of 5 or higher, Exhibiting symptoms of generalized anxiety disorder as determined by the Structured Clinical Interview for DSM-5 (SCID-5-CV), Having regular access to the internet.
Exclusion Criteria:
Currently receiving any form of psychological treatment Having previously undergone long-term psychotherapy Having a primary comorbid psychological disorder other than generalized anxiety disorder, Expressing suicidal ideation, Having completed only primary school education
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional Cognitive Behavioral Group Therapy
Participants in this group received 10 sessions of online cognitive behavioral group therapy
|
his intervention consists of a structured, group-based, online cognitive behavioral therapy program focusing on anxiety management.
The program includes psychoeducation, cognitive restructuring, graduated exposure to anxiety-provoking situations and intolerance of uncertainty, problem-solving, and behavioral exercises.
Sessions were delivered weekly in a standardized, manualized format by a trained therapist, without spiritual or religious content.
|
|
Other: Waiting Group
There is no intervention for this group
|
Participants assigned to the waitlist control group did not receive any active intervention during the study period and were offered the intervention after completion of post-test assessments.
|
|
Experimental: Religiously Integrated Cognitive Behavioral Group Therapy
Participants in this group received 10 sessions of online religiously integrated cognitive behavioral group therapy
|
This intervention consists of a structured, group-based, online cognitive behavioral therapy program integrated with participants' spiritual/religious values.
The program includes psychoeducation about anxiety, cognitive restructuring, exposure to uncertainty, problem-solving, and behavioral exercises, combined with spiritually framed coping strategies such as meaning-making, patience, gratitude, trust, and values-based reflection.
Sessions were delivered weekly in a standardized manualized format by a trained therapist.
The intervention aimed to reduce anxiety symptoms and enhance psychological well-being.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety
Time Frame: Baseline (pre-test), immediately post-intervention (post-test), and 2-month follow-up.
|
The Anxiety Thoughts Inventory (AnTI) is a self-report measure assessing the frequency of anxiety-related thoughts.
The total score is calculated by summing item responses, with higher scores indicating greater levels of maladaptive anxious thinking.
Lower scores reflect fewer anxiety-related cognitions and improvement over time.
Change in scores from baseline to post-intervention and follow-up represents a reduction in anxiety-related thought patterns.
|
Baseline (pre-test), immediately post-intervention (post-test), and 2-month follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Well-being
Time Frame: Baseline (pre-test), immediately post-intervention (post-test), and 2-month follow-up.
|
The PERMA Well-Being Scale is a self-report measure assessing overall psychological well-being across five domains: Positive Emotion, Engagement, Relationships, Meaning, and Accomplishment.
Total scores are derived by averaging item responses, with higher scores indicating higher levels of psychological well-being.
An increase in total score reflects improvement in overall well-being.
|
Baseline (pre-test), immediately post-intervention (post-test), and 2-month follow-up.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ekinci, PhD Candidate, Ibn Haldun University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-71395021-020-9865
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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