- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07299045
The Impact of Mindfulness-Based Psychoeducation on Perceived Stress, Intolerance of Uncertainty, and Cognitive Flexibility in Patients With Anxiety Disorders (Anxiety)
The Impact of Mindfulness-Based Psychoeducation on Perceived Stress, Intolerance of Uncertainty, and Cognitive Flexibility in Patients With Anxiety Disorders: A Randomized Controlled Trial
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aydin, Turkey (Türkiye)
- Eda Mert
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being literate
- Having a diagnosed anxiety disorder
- Being 18 years of age or older
Exclusion Criteria:
- Presence of an acute episode of the illness
- Lack of ability to engage in communication
- currently receiving another form of psychotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants receive a structured mindfulness-based psychoeducation programin addition to standard care.
The intervention includes psychoeducational sessions, mindfulness exercises, and practical strategies.
|
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"
|
|
No Intervention: Control
Participants receive standard care only without any additional psychoeducational or mindfulness-based intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale
Time Frame: Pre-test; post-test (at the end of 8-week psychoeducational program); 1-month follow-up test
|
Differences in participants' perceived stress levels pre- and post-psychoeducation. Higher scores obtained from the scale indicate greater levels of perceived stress.
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Pre-test; post-test (at the end of 8-week psychoeducational program); 1-month follow-up test
|
|
Intolerance of Uncertainty Scale
Time Frame: Pre-test; post-test (at the end of 8-week psychoeducational program); 1-month follow-up test
|
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
Time Frame: Pre-test; post-test (at the end of 8-week psychoeducational program); 1-month follow-up test
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/369
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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