NCT07460479

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

March 4, 2026

Last Update Submit

March 10, 2026

Conditions

Anxiety

Keywords

intolerance of uncertaintyecological systems theorycognitive behavioural group therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (pre-intervention) and immediately post-intervention (week 10)

Secondary Outcomes (3)

  • Emotion regulation

    Baseline (pre-intervention) and immediately post-intervention (week 10)

  • Anxiety

    Baseline (pre-intervention) and immediately post-intervention (week 10)

  • Worry

    Baseline (pre-intervention) and immediately post-intervention (week 10)

Study Arms (1)

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.

Behavioral: Extended Cognitive-Behavioral Group Intervention

Interventions

Extended Cognitive-Behavioral Group InterventionBEHAVIORAL

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.

Also known as: CBT-Based Group Intervention for Intolerance of Uncertainty
Extended Cognitive-Behavioral Group Intervention

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Food and Agriculture University

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Ayça Ilgaz, PhD Cand

    Konya Food and Agriculture University

    STUDY DIRECTOR

Central Study Contacts

Ayça Ilgaz, PhD Cand

CONTACT

905541484439ayca.ilgaz@hotmail.com

Zümrüt Gedik, Assoc. Prof.

CONTACT

90 535 597 33 09zumrut.gedik@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

March 4, 2026

Primary Completion

April 4, 2026

Study Completion

June 4, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

IPD from this pilot study will not be made publicly available due to confidentiality and small sample size.

Locations

TU(1)