AnxietyNCT07460479
Pilot Study of an Extended CBT Group Intervention for Intolerance of Uncertainty
A study testing Extended Cognitive-Behavioral Group Intervention in people with Anxiety, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This study will examine the effect of cognitive-behavioral group psychotherapy, structured within the framework of ecological systems theory, on adults' intolerance of uncertainty. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Extended Cognitive-Behavioral Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2026to 4 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Extended Cognitive-Behavioral Group Intervention
- Keywords
- intolerance of uncertainty, ecological systems theory, cognitive behavioural group therapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Cognitive-Behavioral Group InterventionBehavioural
Also called CBT-Based Group Intervention for Intolerance of Uncertainty
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.
| Study group | Role | What they receive |
|---|---|---|
| Extended Cognitive-Behavioral Group Intervention | Experimental | 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. Receives: Behavioral: Extended Cognitive-Behavioral Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intolerance of uncertainty
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.
Measured: Baseline (pre-intervention) and immediately post-intervention (week 10)
Secondary outcomes (3)
Emotion regulation
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.
Measured: Baseline (pre-intervention) and immediately post-intervention (week 10)
Anxiety
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.
Measured: Baseline (pre-intervention) and immediately post-intervention (week 10)
Worry
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.
Measured: Baseline (pre-intervention) and immediately post-intervention (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start4 Mar 2026
- Primary completion4 May 2026
- Study completion4 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group pilot study designed to evaluate the feasibility and preliminary effects of an extended cognitive-behavioral group intervention targeting intolerance of uncertainty. Participants will complete outcome assessments at baseline and post-intervention.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Ilgaz, Izmir Katip Celebi University
- Investigators
- Ayça Ilgaz, PhD Cand, Study director, Konya Food and Agriculture University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460479
- Sponsor's protocol ID
- IzmirKCU-CBT-2026-01
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD from this pilot study will not be made publicly available due to confidentiality and small sample size.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Extended Cognitive-Behavioral Group Psychotherapy Targeting Intolerance of Uncertainty From an Ecological Systems Theory Perspective
- ClinicalTrials.gov ID
- NCT07460479
- Acronym / sponsor ID
- IzmirKCU-CBT-2026-01
- Conditions
- Anxiety
- Keywords
- intolerance of uncertainty, ecological systems theory, cognitive behavioural group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 Jul 2026 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effect of cognitive-behavioral group psychotherapy, structured within the framework of ecological systems theory, on adults' intolerance of uncertainty.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group pilot study designed to evaluate the feasibility and preliminary effects of an extended cognitive-behavioral group intervention targeting intolerance of uncertainty. Participants will complete outcome assessments at baseline and post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Extended Cognitive-Behavioral Group Intervention | Experimental | Behavioral: Extended Cognitive-Behavioral Group InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended Cognitive-Behavioral Group InterventionAlso: CBT-Based Group Intervention for Intolerance of UncertaintyThis 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. | Behavioural | Extended Cognitive-Behavioral Group Intervention |
Primary outcome
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.
3 secondary outcomes
Emotion regulation
Time frame: Baseline (pre-intervention) and immediately post-intervention (week 10)
Anxiety
Time frame: Baseline (pre-intervention) and immediately post-intervention (week 10)
Worry
Time frame: Baseline (pre-intervention) and immediately post-intervention (week 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. IPD from this pilot study will not be made publicly available due to confidentiality and small sample size.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayça Ilgaz, PhD Cand study director
Konya Food and Agriculture University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended Cognitive-Behavioral Group Intervention in people with Anxiety, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intolerance of uncertainty (time frame: Baseline (pre-intervention) and immediately post-intervention (week 10)). 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 10 Sep 2026.