Pilot Study of an Extended CBT Group Intervention for Intolerance of Uncertainty

September 7, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Extended Cognitive-Behavioral Group Intervention
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:
  • CBT-Based Group Intervention for Intolerance of Uncertainty

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Katip Celebi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 4, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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