NCT07297056

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 3, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 9, 2025

Last Update Submit

December 26, 2025

Conditions

Keywords

Bipolar disorder, forgiveness, mindfulness, psychiatric nursing, self-compassion.

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 8 weeks

Secondary Outcomes (2)

  • Between-group Differences in Post-intervention Mindfulness and Treatment Adherence Scores

    8 weeks

  • Post-intervention Mindfulness and Treatment Adherence Scores Between Groups

    8 weeks

Study Arms (2)

Mindfulness-Based Psychoeducation

EXPERIMENTAL

Participants will receive an 8-session mindfulness-based psychoeducation program.

Other: Mindfulness-Based Psychoeducation ProgramOther: 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.

Interventions

A structured 8-session mindfulness-based psychoeducation program including mindfulness exercises, psychoeducation, breathing techniques and adherence-support strategies.

Mindfulness-Based Psychoeducation

Standard outpatient psychiatric care delivered by the clinic. No additional psychoeducation or mindfulness intervention is provided.

Mindfulness-Based Psychoeducation

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Söke Fehime Faik Kocagöz Hospital

Aydin, Söke, 09200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Ömer Uslu, PhD, RN

    Söke Fehime Faik Kocagöz Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either the experimental group (mindfulness-based psychoeducation) or the control group with no intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Ömer Uslu, PhD - Principal Investigator

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

March 3, 2025

Primary Completion

May 2, 2025

Study Completion

May 4, 2025

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

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

Locations