NCT07299045

Brief Summary

Mindfulness-based interventions, which cultivate the capacity to remain present with difficult thoughts and emotions and to maintain psychological well-being in the face of such challenges, have been shown to facilitate positive change in individuals with anxiety disorders. The present study aimed to investigate the effects of a mindfulness-based psychoeducational program on perceived stress, intolerance of uncertainty, and cognitive flexibility among individuals diagnosed with anxiety disorders. This randomized controlled trial with pre-test, post-test, and one-month follow-up measurements was conducted with individuals who applied to the Psychiatry Outpatient Clinic at Aydın Atatürk State Hospital and were diagnosed with anxiety disorders. A total of 50 participants were included in the study and were randomly assigned to groups (Experimental: 25; Control: 25). The experimental group underwent an 8-week mindfulness-based psychoeducational program, while no intervention was provided to the control group. Research data were collected using the Personal Information Form, Perceived Stress Scale (PSS), Intolerance of Uncertainty Scale (IUS-12), and Cognitive Flexibility Scale (CFS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

November 23, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

Anxiety disordersMindfulnessPerceived StressIntolerance of UncertaintyCognitive Flexibility

Outcome Measures

Primary Outcomes (3)

  • Perceived Stress Scale

    Differences in participants' perceived stress levels pre- and post-psychoeducation. Higher scores obtained from the scale indicate greater levels of perceived stress.

    Pre-test; post-test (at the end of 8-week psychoeducational program); 1-month follow-up test

  • Intolerance of Uncertainty Scale

    Differences in participants' intolerance of uncertainty levels pre- and post-psychoeducation. Higher scores obtained from the scale indicate greater levels of intolerance of uncertainty.

    Pre-test; post-test (at the end of 8-week psychoeducational program); 1-month follow-up test

  • Cognitive Flexibility Scale

    Differences in participants' cognitive flexibility levels pre- and post-psychoeducation. Higher scores on the scale indicate higher levels of cognitive flexibility.

    Pre-test; post-test (at the end of 8-week psychoeducational program); 1-month follow-up test

Study Arms (2)

Intervention

EXPERIMENTAL

Participants receive a structured mindfulness-based psychoeducation programin addition to standard care. The intervention includes psychoeducational sessions, mindfulness exercises, and practical strategies.

Other: Mindfulness-Based Psychoeducational Program

Control

NO INTERVENTION

Participants receive standard care only without any additional psychoeducational or mindfulness-based intervention.

Interventions

Mindfulness-Based Psychoeducational Program contains 8-sessions named as "Introduction to mindfulness, Exploring Mindfulness, Becoming Mindful of the Autopilot, Being in the Body, Meeting Stress with Mindfulness, Mindful Communication, Staying with Difficulties, A New Beginning"

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being literate
  • Having a diagnosed anxiety disorder
  • Being 18 years of age or older

You may not qualify if:

  • Presence of an acute episode of the illness
  • Lack of ability to engage in communication
  • currently receiving another form of psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eda Mert

Aydin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Since the intervention component of the study included tangible elements such as training and counseling, it was not possible to blind participants or researchers to group allocation. The assignment of participants to groups was carried out by the researchers without blinding. Data for the personal information form and all dependent variables of the study were collected through self-report at both the pretest and posttest stages, and in this respect, the researchers were blinded to the scale results.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 23, 2025

Study Start

November 1, 2023

Primary Completion

June 1, 2024

Study Completion

November 1, 2024

Last Updated

January 9, 2026

Record last verified: 2025-12

Locations