Bipolar DisorderNCT06983834
Mindfulness Psychoeducation for Bipolar Disorder Caregivers' Mindfulness, Burden, Quality of Life and Resilience
A study testing Psychoeducation in people with Bipolar Disorder, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Currently participating in another psychoeducation group,
- Diagnosed with any mental disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar University of Health Sciences
Afyonkarahisar, 03000
Azime KORKMAZ, PhDStudent, 905064053614, korkmazime@gmail.com
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Bipolar Disorder
- Being tested
- Psychoeducation
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
Mindfulness Based Psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psychoeducation |
| Caregivers of Bipolar Disorder Patients (Control) | No intervention | Only pre-test and post-tests will be applied without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Zarit Burden Interview
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.
Measured: 6 months
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36, Short Form-36 Health Survey)
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.
Measured: 6 months
Resilience Scale for Adults
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.
Measured: 6 months
Mindful Attention Awareness Scale
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 May 2025
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study included two groups: an experimental group and a control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azime Korkmaz, Pamukkale University
- Investigators
- Gülay TAŞDEMİR, AssocProfDr, Study director, https://akbis.pau.edu.tr/personel/226
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983834
- Sponsor's protocol ID
- PAU-SBE-AK-01
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06983834
- Acronym / sponsor ID
- PAU-SBE-AK-01
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study included two groups: an experimental group and a control group.
| Arm | Type | Receives |
|---|---|---|
| Caregivers of Bipolar Disorder Patients (Experimental) | Experimental | Behavioral: PsychoeducationMindfulness-based psychoeducation will be applied to the experimental group.There will be pre-test and post-tests. |
| Caregivers of Bipolar Disorder Patients (Control) | No intervention | –Only pre-test and post-tests will be applied without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Currently participating in another psychoeducation group,
- Diagnosed with any mental disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationMindfulness Based Psychoeducation | Behavioural | Caregivers of Bipolar Disorder Patients (Experimental) |
Primary outcome
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.
4 secondary outcomes
Zarit Burden Interview
Time frame: 6 months
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36, Short Form-36 Health Survey)
Time frame: 6 months
Resilience Scale for Adults
Time frame: 6 months
Mindful Attention Awareness Scale
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gülay TAŞDEMİR, AssocProfDr study director
https://akbis.pau.edu.tr/personel/226
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Bipolar Disorder, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Azime KORKMAZ, PhDStudent (905064053614, korkmazime@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Descriptive Characteristics Form (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.