Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT07297056
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2025-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mindfulness Psychoeducation for Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to either the experimental group (mindfulness-based psychoeducation) or the control group with no intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mindfulness Level', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Evaluation of the change in the total score of the Mindfulness Scale'}], 'secondaryOutcomes': [{'measure': 'Between-group Differences in Post-test Scores', 'timeFrame': '8 weeks', 'description': 'Comparison of post-intervention differences in mindfulness and treatment adherence scores between the experimental and control groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bipolar disorder, forgiveness, mindfulness, psychiatric nursing, self-compassion.'], 'conditions': ['Mindfulness Based Stress Reduction', 'Mindfulness Meditation', 'Bipolar Affective Disorder', 'Psychiatric Nursing Intervention', 'Treatment Non-Adherence']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nFindings 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.', 'detailedDescription': '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.\n\nMindfulness-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.\n\nA 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.\n\nForgiveness-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.\n\nThe 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.\n\nBy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosis of bipolar disorder according to DSM-5 criteria Age between 18-65 years Being 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 providing informed consent\n\nExclusion Criteria:\n\nPresence 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'}, 'identificationModule': {'nctId': 'NCT07297056', 'briefTitle': 'Mindfulness Psychoeducation for Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'The Effect of Mindfulness-Based Psychoeducation Programme on Mindfulness, Self-Compassion and Forgiveness Tendencies of Patients With Bipolar Disorder: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'OMER-RCT-2025-BAB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness-Based Psychoeducation', 'description': 'Participants will receive an 8-session mindfulness-based psychoeducation program.', 'interventionNames': ['Other: Mindfulness-Based Psychoeducation Program', 'Other: routine care']}, {'type': 'NO_INTERVENTION', 'label': 'Control: Routine Care', 'description': '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.'}], 'interventions': [{'name': 'Mindfulness-Based Psychoeducation Program', 'type': 'OTHER', 'description': 'A structured 8-session mindfulness-based psychoeducation program including mindfulness exercises, psychoeducation, breathing techniques and adherence-support strategies.', 'armGroupLabels': ['Mindfulness-Based Psychoeducation']}, {'name': 'routine care', 'type': 'OTHER', 'description': 'Standard outpatient psychiatric care delivered by the clinic. No additional psychoeducation or mindfulness intervention is provided.', 'armGroupLabels': ['Mindfulness-Based Psychoeducation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09200', 'city': 'Aydin', 'state': 'Söke', 'country': 'Turkey (Türkiye)', 'facility': 'Söke Fehime Faik Kocagöz Hospital', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}], 'overallOfficials': [{'name': 'Ömer Uslu, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Söke Fehime Faik Kocagöz Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ömer USLU', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Ömer Uslu, PhD - Principal Investigator', 'investigatorFullName': 'Ömer USLU', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}