Bipolar Disorder (BD)NCT07297056
Mindfulness Psychoeducation for Bipolar Disorder
A study testing Mindfulness-Based Psychoeducation Program and routine care in people with Bipolar Disorder (BD) and Mindfulness-Based Stress Reduction, run by Ömer USLU at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled experimental study investigates the effectiveness of a mindfulness-based psychoeducation program on mindfulness, self-compassion, and forgiveness among individuals diagnosed with bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder (BD), Mindfulness-Based Stress Reduction, Mindfulness Meditation
- What is being tested?
- Mindfulness-Based Psychoeducation Program and routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2025to 4 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of bipolar disorder according to DSM-5 criteria
- Age between 18 and 65 years
- Clinically stable for at least the past 3 months
- Able to communicate, read, and understand Turkish
- Receiving outpatient psychiatric follow-up
- Willingness to participate and provide informed consent
Who cannot join
- Presence of acute psychotic symptoms requiring immediate hospitalization
- Comorbid intellectual disability, neurological disorder, or severe cognitive impairment
- Substance or alcohol dependence within the last 6 months
- Participation in any mindfulness-based or psychoeducational program within the last year
- Severe visual or hearing impairment preventing participation
- Any condition judged by the clinician to contraindicate participation in group sessions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Söke Fehime Faik Kocagöz Hospital
Aydin, Söke, 09200
About this study
Official title: The Effect of Mindfulness-Based Psychoeducation Programme on Mindfulness, Self-Compassion and Forgiveness Tendencies of Patients With Bipolar Disorder: A Randomised Controlled Trial
This randomized controlled experimental study investigates the effectiveness of a mindfulness-based psychoeducation program on mindfulness, self-compassion, and forgiveness among individuals diagnosed with bipolar disorder. Bipolar disorder is a chronic psychiatric condition characterized by fluctuations in mood, energy, and functional capacity, often accompanied by emotional dysregulation, impaired insight, and challenges in interpersonal relationships. Psychosocial interventions that cultivate emotional awareness and adaptive coping may support recovery and enhance long-term functioning.
In this study, 40 clinically stable patients with bipolar disorder were randomly assigned to either an experimental group (n=20) or a control group (n=20). The experimental group received a structured mindfulness-based psychoeducation program, while the control group received no additional intervention beyond usual care. Participants completed pre- and post-intervention assessments using a personal information form, the Mindfulness Scale, the Self-Compassion Scale-Short Form, and the Heartland Forgiveness Scale.
Findings demonstrated that individuals who participated in the mindfulness-based psychoeducation program showed significantly greater improvements in mindfulness, self-compassion, and forgiveness compared with the control group. These results suggest that integrating mindfulness-based psychoeducation into routine care may promote emotional resilience, enhance illness insight, support symptom management, and strengthen interpersonal functioning in individuals with bipolar disorder.
Read the detailed description
Bipolar disorder is a chronic and recurrent psychiatric condition characterized by significant fluctuations in mood, energy levels, and functional capacity. Although pharmacological treatment remains the cornerstone of managing manic and depressive episodes, many individuals continue to experience residual symptoms, emotional dysregulation, heightened stress reactivity, and interpersonal difficulties even during periods of clinical stability. These challenges highlight the need for holistic approaches that address not only symptom reduction but also emotional regulation, self-awareness, and psychological well-being.
Mindfulness-based interventions have gained increasing attention as a complementary therapeutic approach for individuals living with bipolar disorder. Mindfulness practices cultivate the ability to observe internal experiences-thoughts, emotions, and bodily sensations-with openness, acceptance, and non-judgment. This enhanced awareness may reduce automatic emotional reactions, support early recognition of mood changes, and promote more adaptive coping strategies. By helping individuals respond rather than react to internal and external stressors, mindfulness may foster a sense of emotional balance and psychological resilience that is particularly valuable in bipolar disorder.
A key component closely linked to mindfulness is self-compassion, which involves treating oneself with kindness, understanding, and emotional warmth during times of difficulty or perceived inadequacy. Individuals with bipolar disorder often struggle with self-criticism, guilt, and negative self-appraisal stemming from the chronic and disruptive nature of the illness. Enhancing self-compassion may therefore help reduce emotional distress, facilitate more adaptive self-management, and strengthen long-term recovery-oriented functioning.
Forgiveness-toward oneself, others, and uncontrollable life circumstances-represents another important mechanism that may contribute to emotional healing in bipolar disorder. Difficulties associated with the illness may lead to strained relationships, unresolved emotional conflicts, or lingering feelings of resentment or self-blame. Developing forgiveness may promote emotional release, reduce psychological burden, and support healthier interpersonal dynamics.
The mindfulness-based psychoeducation program evaluated in this study integrates these components into a structured framework designed to enhance both emotional skills and illness-related insight. The program includes guided mindfulness practices such as breathing awareness and body scan exercises, psychoeducation modules that address symptom patterns and mood regulation, and reflective activities aimed at cultivating compassionate awareness and forgiveness. Through these combined elements, the intervention seeks to strengthen self-regulation capacities, promote acceptance-based coping, and improve psychosocial well-being in individuals with bipolar disorder.
By targeting mindfulness, self-compassion, and forgiveness simultaneously, the program offers a comprehensive approach to supporting emotional stability and personal recovery. This integrated model has the potential to enhance illness management, improve interpersonal functioning, and reduce the psychological burdens commonly experienced by individuals living with bipolar disorder.
- Being tested
- Mindfulness-Based Psychoeducation Program, routine care
- Keywords
- Bipolar disorder, forgiveness, mindfulness, psychiatric nursing, self-compassion.
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Psychoeducation ProgramOther
A structured 8-session mindfulness-based psychoeducation program including mindfulness exercises, psychoeducation, breathing techniques and adherence-support strategies.
routine careOther
Standard outpatient psychiatric care delivered by the clinic. No additional psychoeducation or mindfulness intervention is provided.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Psychoeducation | Experimental | Participants will receive an 8-session mindfulness-based psychoeducation program. Receives: Other: Mindfulness-Based Psychoeducation Program; Other: routine care |
| Control: Routine Care | No intervention | Participants in this arm will receive Routine Care provided by the psychiatric outpatient clinic. Routine Care includes standard follow-up, medication management, and usual clinical monitoring. No additional psychoeducation or mindfulness-based intervention will be provided during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mindfulness Level (Mindful Attention Awareness Scale)
Mindfulness level was assessed using the Mindful Attention Awareness Scale (MAAS), a self-report questionnaire consisting of 15 items. Total scores range from 15 to 90, with higher scores indicating greater levels of mindfulness. The outcome measure represents the change in total MAAS score from baseline to post-intervention.
Measured: Baseline and 8 weeks
Secondary outcomes (2)
Between-group Differences in Post-intervention Mindfulness and Treatment Adherence Scores
Between-group differences in post-intervention scores were evaluated using the Mindful Attention Awareness Scale (MAAS) and the Medication Adherence Rating Scale (MARS).
Mindfulness was assessed with the MAAS, a 15-item self-report scale with total scores ranging from 15 to 90, where higher scores indicate greater mindfulness.
Treatment adherence was assessed using the MARS, which consists of 10 items, with total scores ranging from 0 to 10, where higher scores indicate better medication adherence.
The outcome measure represents the comparison of post-test total scores between the experimental and control groups at the end of the intervention.
Measured: 8 weeks
Post-intervention Mindfulness and Treatment Adherence Scores Between Groups
Post-intervention differences between the experimental and control groups were evaluated using the following scales:
Mindfulness: Assessed with the Mindful Attention Awareness Scale (MAAS), a 15-item self-report scale with total scores ranging from 15 to 90. Higher scores indicate greater mindfulness.
Treatment Adherence: Assessed with the Medication Adherence Rating Scale (MARS), a 10-item self-report scale with total scores ranging from 0 to 10. Higher scores indicate better adherence to prescribed treatment.
The outcome measure represents the comparison of post-test total scores between groups at the end of the 8-week intervention.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start3 Mar 2025
- Primary completion2 May 2025
- Study completion4 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder (BD)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either the experimental group (mindfulness-based psychoeducation) or the control group with no intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ömer USLU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ömer USLU, Aydin Adnan Menderes University
- Investigators
- Ömer Uslu, PhD, RN, Principal investigator, Söke Fehime Faik Kocagöz Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297056
- Sponsor's protocol ID
- OMER-RCT-2025-BAB
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared due to ethical and institutional restrictions. The dataset includes sensitive health information from patients diagnosed with bipolar disorder, and the informed consent process did not include permission for public data sharing. Therefore, in accordance with privacy regulations and ethical committee requirements, IPD will not be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Psychoeducation Programme on Mindfulness, Self-Compassion and Forgiveness Tendencies of Patients With Bipolar Disorder: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07297056
- Acronym / sponsor ID
- OMER-RCT-2025-BAB
- Keywords
- Bipolar disorder, forgiveness, mindfulness, psychiatric nursing, self-compassion.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ömer USLUUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 4 May 2025 (actual)
- First posted
- 22 Dec 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 randomized controlled experimental study investigates the effectiveness of a mindfulness-based psychoeducation program on mindfulness, self-compassion, and forgiveness among individuals diagnosed with bipolar disorder. Bipolar disorder is a chronic psychiatric condition characterized by fluctuations in mood, energy, and functional capacity, often accompanied by emotional dysregulation, impaired insight, and challenges in interpersonal relationships. Psychosocial interventions that cultivate emotional awareness and adaptive coping may support recovery and enhance long-term functioning.
In this study, 40 clinically stable patients with bipolar disorder were randomly assigned to either an experimental group (n=20) or a control group (n=20). The experimental group received a structured mindfulness-based psychoeducation program, while the control group received no additional intervention beyond usual care. Participants completed pre- and post-intervention assessments using a personal information form, the Mindfulness Scale, the Self-Compassion Scale-Short Form, and the Heartland Forgiveness Scale.
Findings demonstrated that individuals who participated in the mindfulness-based psychoeducation program showed significantly greater improvements in mindfulness, self-compassion, and forgiveness compared with the control group. These results suggest that integrating mindfulness-based psychoeducation into routine care may promote emotional resilience, enhance illness insight, support symptom management, and strengthen interpersonal functioning in individuals with bipolar disorder.
Detailed description
Bipolar disorder is a chronic and recurrent psychiatric condition characterized by significant fluctuations in mood, energy levels, and functional capacity. Although pharmacological treatment remains the cornerstone of managing manic and depressive episodes, many individuals continue to experience residual symptoms, emotional dysregulation, heightened stress reactivity, and interpersonal difficulties even during periods of clinical stability. These challenges highlight the need for holistic approaches that address not only symptom reduction but also emotional regulation, self-awareness, and psychological well-being.
Mindfulness-based interventions have gained increasing attention as a complementary therapeutic approach for individuals living with bipolar disorder. Mindfulness practices cultivate the ability to observe internal experiences-thoughts, emotions, and bodily sensations-with openness, acceptance, and non-judgment. This enhanced awareness may reduce automatic emotional reactions, support early recognition of mood changes, and promote more adaptive coping strategies. By helping individuals respond rather than react to internal and external stressors, mindfulness may foster a sense of emotional balance and psychological resilience that is particularly valuable in bipolar disorder.
A key component closely linked to mindfulness is self-compassion, which involves treating oneself with kindness, understanding, and emotional warmth during times of difficulty or perceived inadequacy. Individuals with bipolar disorder often struggle with self-criticism, guilt, and negative self-appraisal stemming from the chronic and disruptive nature of the illness. Enhancing self-compassion may therefore help reduce emotional distress, facilitate more adaptive self-management, and strengthen long-term recovery-oriented functioning.
Forgiveness-toward oneself, others, and uncontrollable life circumstances-represents another important mechanism that may contribute to emotional healing in bipolar disorder. Difficulties associated with the illness may lead to strained relationships, unresolved emotional conflicts, or lingering feelings of resentment or self-blame. Developing forgiveness may promote emotional release, reduce psychological burden, and support healthier interpersonal dynamics.
The mindfulness-based psychoeducation program evaluated in this study integrates these components into a structured framework designed to enhance both emotional skills and illness-related insight. The program includes guided mindfulness practices such as breathing awareness and body scan exercises, psychoeducation modules that address symptom patterns and mood regulation, and reflective activities aimed at cultivating compassionate awareness and forgiveness. Through these combined elements, the intervention seeks to strengthen self-regulation capacities, promote acceptance-based coping, and improve psychosocial well-being in individuals with bipolar disorder.
By targeting mindfulness, self-compassion, and forgiveness simultaneously, the program offers a comprehensive approach to supporting emotional stability and personal recovery. This integrated model has the potential to enhance illness management, improve interpersonal functioning, and reduce the psychological burdens commonly experienced by individuals living with bipolar disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either the experimental group (mindfulness-based psychoeducation) or the control group with no intervention.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Psychoeducation | Experimental | Other: Mindfulness-Based Psychoeducation Program, Other: routine careParticipants will receive an 8-session mindfulness-based psychoeducation program. |
| Control: Routine Care | No intervention | –Participants in this arm will receive Routine Care provided by the psychiatric outpatient clinic. Routine Care includes standard follow-up, medication management, and usual clinical monitoring. No additional psychoeducation or mindfulness-based intervention will be provided during the study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of bipolar disorder according to DSM-5 criteria
- Age between 18 and 65 years
- Clinically stable for at least the past 3 months
- Able to communicate, read, and understand Turkish
- Receiving outpatient psychiatric follow-up
Key exclusion criteria (6 listed)
- Presence of acute psychotic symptoms requiring immediate hospitalization
- Comorbid intellectual disability, neurological disorder, or severe cognitive impairment
- Substance or alcohol dependence within the last 6 months
- Participation in any mindfulness-based or psychoeducational program within the last year
- Severe visual or hearing impairment preventing participation
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 |
|---|---|---|
| Mindfulness-Based Psychoeducation ProgramA structured 8-session mindfulness-based psychoeducation program including mindfulness exercises, psychoeducation, breathing techniques and adherence-support strategies. | Other | Mindfulness-Based Psychoeducation |
| routine careStandard outpatient psychiatric care delivered by the clinic. No additional psychoeducation or mindfulness intervention is provided. | Other | Mindfulness-Based Psychoeducation |
Primary outcome
Change in Mindfulness Level (Mindful Attention Awareness Scale)
Time frame: Baseline and 8 weeks
Mindfulness level was assessed using the Mindful Attention Awareness Scale (MAAS), a self-report questionnaire consisting of 15 items. Total scores range from 15 to 90, with higher scores indicating greater levels of mindfulness. The outcome measure represents the change in total MAAS score from baseline to post-intervention.
2 secondary outcomes
Between-group Differences in Post-intervention Mindfulness and Treatment Adherence Scores
Time frame: 8 weeks
Post-intervention Mindfulness and Treatment Adherence Scores Between Groups
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared due to ethical and institutional restrictions. The dataset includes sensitive health information from patients diagnosed with bipolar disorder, and the informed consent process did not include permission for public data sharing. Therefore, in accordance with privacy regulations and ethical committee requirements, IPD will not be made available to other researchers
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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. This study is not recruiting at the moment.
Ömer Uslu, PhD, RN principal investigator
Söke Fehime Faik Kocagöz Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Psychoeducation Program and routine care in people with Bipolar Disorder (BD) and Mindfulness-Based Stress Reduction, run by Ömer USLU 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 31 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mindfulness Level (Mindful Attention Awareness Scale) (time frame: Baseline and 8 weeks). 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 31 Dec 2025.