NCT06983834

Brief Summary

This study was designed to determine the effect of mindfulness-based psychoeducation applied to primary caregivers of individuals diagnosed with bipolar disorder on their mindfulness, caregiver burden, quality of life, and psychological resilience.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started May 2025

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

Study Progress82%
May 2025Aug 2026

Study Start

First participant enrolled

May 1, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Expected
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

May 6, 2025

Last Update Submit

May 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Descriptive Characteristics Form

    The Descriptive Characteristics Form consists of 16 questions related to individuals' sociodemographic information and personal characteristics (Age, Gender, Marital Status, Educational Status, Employment Status, Income Level, Caregiving Support, Duration of Being the Primary Caregiver, Smoking and Alcohol Use, Hobby Status, Social Support Information). It is a data collection tool developed based on a literature review.

    6 months

Secondary Outcomes (4)

  • Zarit Burden Interview

    6 months

  • The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36, Short Form-36 Health Survey)

    6 months

  • Resilience Scale for Adults

    6 months

  • Mindful Attention Awareness Scale

    6 months

Study Arms (2)

Caregivers of Bipolar Disorder Patients (Experimental)

EXPERIMENTAL

Mindfulness-based psychoeducation will be applied to the experimental group.There will be pre-test and post-tests.

Behavioral: Psychoeducation

Caregivers of Bipolar Disorder Patients (Control)

NO INTERVENTION

Only pre-test and post-tests will be applied without any intervention.

Interventions

PsychoeducationBEHAVIORAL

Mindfulness Based Psychoeducation

Caregivers of Bipolar Disorder Patients (Experimental)

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years or older,
  • At least a primary school graduate,
  • Able to hear, understand spoken language, and communicate,
  • Has been a primary caregiver for at least 6 months and is participating voluntarily.

You may not qualify if:

  • Currently participating in another psychoeducation group,
  • Diagnosed with any mental disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar University of Health Sciences

Afyonkarahisar, 03000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Gülay TAŞDEMİR, AssocProfDr

    https://akbis.pau.edu.tr/personel/226

    STUDY DIRECTOR

Central Study Contacts

Azime KORKMAZ, PhDStudent

CONTACT

Gülay TAŞDEMİR, AssocProfDr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study included two groups: an experimental group and a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 21, 2025

Study Start

May 1, 2025

Primary Completion

September 15, 2025

Study Completion (Estimated)

August 15, 2026

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations