Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06983834

Mindfulness Psychoeducation for Bipolar Disorder Caregivers' Mindfulness, Burden, Quality of Life and Resilience

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar University of Health Sciences

Afyonkarahisar, 03000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Azime KORKMAZ, PhDStudent

CONTACT

[email protected]

905064053614

About this study

Bipolar disorder is a chronic mental illness characterized by alternating episodes of opposing mood states (mania/hypomania and depression) and euthymic periods. Providing continuous care to individuals diagnosed with bipolar disorder can be highly challenging. Considering factors such as medication management, hospital follow-ups, patient behavior during episodes, and their attitudes toward themselves and others, being a primary caregiver is a demanding responsibility. Caregivers may face challenges such as constant caregiving burden, social isolation, burnout, neglecting self-care, and ignoring their own need for help. However, due to their perceived obligation to prioritize the patient, they may find themselves without adequate support.

Psychiatric nurses should approach not only the chronically mentally ill patient but also their caregivers, who are integral parts of the patient's environment, from a holistic perspective. The home environment of the patient, and particularly the attitude of the family and primary caregiver, plays a significant role in the prevention of relapses. From this holistic point of view, psychoeducation programs are expected to increase caregivers' psychological resilience, quality of life, and mindfulness levels, while reducing their caregiving burden. Such outcomes are anticipated to not only benefit the caregiver and the patient but also strengthen the broader society, as they may contribute to the reduction of relapse rates. Consequently, this could positively impact the national economy by decreasing healthcare utilization. Protecting caregivers may also lead to a reduced need for healthcare services directed toward them.

Psychoeducation is one of the core roles of psychiatric nurses. The recognition and expansion of mindfulness-based psychoeducation practices in the field are expected to provide significant support to both patients and their families.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Psychoeducation

Behavioral

Mindfulness Based Psychoeducation

Primary outcomes

  1. The Descriptive Characteristics Form

    Time frame: 6 months

    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.

Secondary outcomes

  1. Zarit Burden Interview

    Time frame: 6 months

    The scale was developed by Zarit, Reever, and Bach-Peterson to measure caregiver burden.It is a scale that can be completed either by the caregivers themselves or through interviews conducted by the researcher. The scale uses a Likert-type rating system ranging from 0 to 4 (never, rarely, sometimes, quite frequently, nearly always). Scores on the scale range from 0 to 88. The items primarily focus on social and emotional aspects, and a higher total score indicates a greater level of burden or distress experienced by the caregiver.

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

    Time frame: 6 months

    The SF-36 Survey was developed by Ware and Sherbourne (1992) to assess quality of life.This scale is used to assess physical and mental health in individuals over the age of 14, whether they have various health conditions or are healthy. The SF-36 is a generic quality of life scale and provides a comprehensive evaluation. The scale consists of 36 items, which include: physical functioning (10 items), role limitations due to physical health problems (2 items), social functioning (2 items), role limitations due to emotional problems (3 items), mental health (5 items), vitality (4 items), bodily pain (2 items), general health perceptions (5 items), and perceived change in health status (1 item). Each item is evaluated individually and scored on a scale from 0 to 100.

  3. Resilience Scale for Adults

    Time frame: 6 months

    The scale was developed by Friborg et al. (2003) to measure psychological resilience in adults. The scale consists of 33 items and 6 subscales: self-perception, perception of the future, structured style, social competence, family cohesion, and social resources. It is a 5-point Likert-type scale. The response options are scored as follows: 1 - Strongly Disagree, 2 - Disagree, 3 - Neutral, 4 - Agree, and 5 - Strongly Agree.

  4. Mindful Attention Awareness Scale

    Time frame: 6 months

    The scale was developed by Brown and Ryan (2003) to measure the level of mindfulness and consists of 15 items.In the scale, each item is scored based on how frequently the individual experiences that specific situation. It is a 6-point Likert-type scale with the following response options: "Almost never: 6," "Very rarely: 5," "Rarely: 4," "Sometimes: 3," "Often: 2," and "Almost always: 1." The total score on the scale ranges from a minimum of 15 to a maximum of 90. Based on the total score, individuals scoring between 66 and 90 are considered to have a high level of mindfulness, scores between 41 and 65 indicate a moderate level, and scores of 40 or below reflect a low level of mindfulness.

Study contacts

Contact information is provided by the study sponsor or research team.

Azime KORKMAZ, PhDStudent

CONTACT

[email protected]

905064053614

Gülay TAŞDEMİR, AssocProfDr.

CONTACT

[email protected]

905386418674

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

The Effect of Mindfullness-Based Psychoeducation Applied to Primary Caregivers of Individuals With Bipolar Disorder on Caregivers' Mindfulness, Care Burden, Quality of Life and Psychological Resilience

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.