- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460479
Pilot Study of an Extended CBT Group Intervention for Intolerance of Uncertainty
March 10, 2026 updated by: Ayça Ilgaz, Izmir Katip Celebi University
Efficacy of an Extended Cognitive-Behavioral Group Psychotherapy Targeting Intolerance of Uncertainty From an Ecological Systems Theory Perspective
This study will examine the effect of cognitive-behavioral group psychotherapy, structured within the framework of ecological systems theory, on adults' intolerance of uncertainty.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will examine the effect of cognitive-behavioral group therapy, developed from an ecological systems perspective on intolerance of uncertainty on the coping skills of emerging adults experiencing individual and social uncertainties during their quarter-life crisis.
The participants' intolerance of uncertainty, emotion regulation, and anxiety levels will be examined as outcome (dependent) variables in the intervention.
The intervention will address uncertainties experienced in the micro, meso, exo, macro, and chrono systems of ecological systems.
The data obtained as a result of the intervention will be evaluated in terms of the effects of the protocol developed on the outcome variables and the impact of sociopolitical factors on experiences of uncertainty and anxiety.
The sample of the study will consist of university students in their adult years.
The intervention process will be structured according to the basic principles of group therapy (universality, altruism, instilling hope, etc.).
The intervention will be structured primarily around psychoeducation and skill building and will be preventive in nature.
Quantitative and qualitative assessments are planned for the study.
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ayça Ilgaz, PhD Cand
- Phone Number: 905541484439
- Email: ayca.ilgaz@hotmail.com
Study Contact Backup
- Name: Zümrüt Gedik, Assoc. Prof.
- Phone Number: 90 535 597 33 09
- Email: zumrut.gedik@gmail.com
Study Locations
-
-
-
Konya, Turkey (Türkiye)
- Recruiting
- Konya Food and Agriculture University
-
Contact:
- Ayça Ilgaz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Be an undergraduate/graduate student (including preparatory class)
- Experience difficulties related to uncertainty
- Be between the ages of 18 and 29
- Have sufficient proficiency in reading, writing, and speaking Turkish
Exclusion Criteria:
- Being 29 years of age or older,
- Having schizophrenia, other psychotic disorders, alcohol and substance use disorders
- Individuals experiencing severe depression symptoms who require additional intervention to engage in the group process
- Individuals with cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Extended Cognitive-Behavioral Group Intervention
Participants will receive an extended cognitive-behavioral group intervention targeting intolerance of uncertainty.
The intervention consists of weekly structured group sessions including cognitive restructuring, behavioral exercises, exposure to uncertainty, and emotion regulation techniques.
|
This is an extended cognitive-behavioral group intervention designed to target intolerance of uncertainty.
The program is informed by Ecological Systems Theory, emphasizing the interaction of individuals with their social and environmental contexts.
It includes structured weekly sessions incorporating cognitive restructuring, behavioral experiments, exposure to uncertainty, and emotion regulation techniques.
The intervention is delivered in a group format over 10 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intolerance of uncertainty
Time Frame: Baseline (pre-intervention) and immediately post-intervention (week 10)
|
The Intolerance of Uncertainty Scale-12 will be used.
The scale assesses the behavioral, emotional, and cognitive factors of intolerance of uncertainty.
The overall score range for the scale is 12-60.
Higher scores indicate a high level of intolerance for uncertainty.
|
Baseline (pre-intervention) and immediately post-intervention (week 10)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotion regulation
Time Frame: Baseline (pre-intervention) and immediately post-intervention (week 10)
|
The Emotion Regulation Difficulty Scale-Short Form (ERDS-16) will be used.
The scale was developed to measure the difficulties individuals experience in regulating their emotions.
The overall score range for the scale is 16-80.
Higher scores indicate greater emotion dysregulation.
|
Baseline (pre-intervention) and immediately post-intervention (week 10)
|
|
Anxiety
Time Frame: Baseline (pre-intervention) and immediately post-intervention (week 10)
|
State Anxiety Inventory-STAI-1 and Trait Anxiety Inventory-STAI-2 will be used.
The overall score range for the scale is 20-80.
Higher scores indicate greater anxiety.
|
Baseline (pre-intervention) and immediately post-intervention (week 10)
|
|
Worry
Time Frame: Baseline (pre-intervention) and immediately post-intervention (week 10)
|
Penn State Worry Scale will be used.
The scale assesses the tendency toward pathological anxiety.
The overall score range for the scale is 16-80.
A higher score indicates a higher level of pathological concern.
|
Baseline (pre-intervention) and immediately post-intervention (week 10)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ayça Ilgaz, PhD Cand, Konya Food and Agriculture University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 4, 2026
Primary Completion (Estimated)
April 4, 2026
Study Completion (Estimated)
June 4, 2026
Study Registration Dates
First Submitted
March 4, 2026
First Submitted That Met QC Criteria
March 4, 2026
First Posted (Actual)
March 10, 2026
Study Record Updates
Last Update Posted (Actual)
March 12, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IzmirKCU-CBT-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD from this pilot study will not be made publicly available due to confidentiality and small sample size.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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