NCT06721858

Brief Summary

4.503 / 5.000 Bipolar disorder is a serious mood disorder that requires lifelong treatment and is characterized by recurring periods of depression, mania, hypomania or mixed episodes without a specific order, completely normal between episodes or thought to be with minimal symptom levels, has a high mortality and morbidity rate, causes serious deterioration in the quality of life in terms of occupational, interpersonal, social, familial and economic aspects. It causes serious deterioration in the lives of patients due to suicide attempts, substance abuse, poor functionality, low academic success, deterioration in interpersonal communication and repeated hospitalizations. One of the conditions that most affects the course of the disease in bipolar disorder and causes recurrences is treatment compliance. Treatment compliance includes individuals accepting and applying the treatments recommended for their illness, going to check-ups, controlling their emotions, continuing treatment programs, using medications as often and at the dose prescribed, continuing other treatment methods and healthy behavioral changes (individual coping strategies, skills training, emotion management training, awareness training, etc.). In bipolar patients, where mood swings are frequent, emotional reactivity is one of the important factors affecting the treatment compliance process. The concept of emotional reactivity can be defined as the emotional sensitivity experienced by the individual in response to many stimuli and stimuli, the emotional intensity experienced strongly, and the emotional resistance shown during the period until reaching the basic emotion. The emotions that usually create emotional reactions are emotions such as anger, anxiety, stress, and hurt. Even individuals without a psychiatric diagnosis can sometimes have difficulty controlling such emotions when they encounter them. Therefore, it is very important for these bipolar individuals to have mood awareness so that they can recognize these emotions and exhibit appropriate behaviors towards emotions. Since individuals who are aware of their emotions will increase their emotional attention and emotional clarity, it becomes easier for them to recognize their emotions. Patients' compliance with treatment positively affects the course of the disease and supports the increase in functionality with regular treatment. Psychosocial interventions for patients with bipolar disorder contribute to a decrease in patients' symptoms, increased compliance with medical treatment, and a decrease in the need for rehospitalization, as well as increased social and occupational functioning. This study was planned to examine the effects of emotion-focused therapy applied to patients with bipolar disorder on the patients' mood awareness and emotional reactivity. The application of the study will be carried out with patients diagnosed with bipolar disorder in remission at the Psychiatry Clinic of Muğla Sıtkı Koçman University Faculty of Medicine Hospital after obtaining permissions. In determining the hospital where the study will be conducted, the current number of patients, accessibility, cooperation of the team, and the absence of structured group emotion-focused therapy studies in the institution were taken into consideration. The content of the emotion-focused therapy program planned to be used in the study was prepared by obtaining the opinions of expert faculty members working in different universities. The study was planned with bipolar disorder patients who were hospitalized in a psychiatric clinic and started the treatment process, and in an experimental setting (pre-test-post-test control group, follow-up measurement), 6 sessions were planned for the intervention group during their hospitalization, 2 days a week, the first 3 sessions were 30 minutes and the other 3 sessions were 40 minutes. Before starting the emotion-focused therapy, the purpose of the study was explained to the intervention group, the data collection tools were introduced, and their verbal and written permissions were obtained, and the pre-test was applied face to face. Face-to-face interviews and 6 sessions of emotion-focused therapy application will be held in the psychiatric clinic interview room. As the final test application, the scales will be applied face to face by the clinic nurse immediately after the last session of emotion-focused therapy. A follow-up test will be performed on the patients one month later. The patient will be met with a total of 7 times. It is assumed that the emotion-focused therapy application will increase the patient's ability to recognize individual emotions, manage emotions, medication compliance and functionality level after discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

May 21, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

November 28, 2024

Last Update Submit

April 17, 2026

Conditions

Keywords

emotion focused therapyemotional reactivitymood awarenessbipolar disorder

Outcome Measures

Primary Outcomes (1)

  • EFFECTS OF EMOTION-FOCUSED THERAPY APPLIED TO PATIENTS WITH BIPOLAR DIAGNOSIS ON THEIR MOOD AWARENESS AND EMOTIONAL REACTIVITY

    By creating randomized controlled groups, emotion-focused therapy will be applied between the control and intervention groups.

    6 month

Study Arms (2)

Control group, where no intervention will be made and only research questionnaires will be applied

PLACEBO COMPARATOR

The determined scale forms will be applied to the people in the control group who will be included in the study as a pre-test at the beginning of the study, as a post-test 10 days after the pre-test, and finally as a follow-up test one month after the pre-test.

Other: scale form

intervention group to which emotion-focused therapy will be applied

EXPERIMENTAL

Participants in the intervention group will first be given face-to-face individual interviews to establish the therapeutic environment and relationship (Individual interviews are designed as orientation, diagnosis and planning stages, 30-minute interviews). Then, three intervention stages (40-minute, group therapy) will be applied and the last session will be both intervention (post-test application) and termination stage (completion of emotion-focused therapy application). After the individual interviews, individuals will be included in 3 intervention sessions as group training. It is planned that each group will have at least 4 and at most 6 people. If the specified number cannot be reached, the study will continue until the specified number is reached.

Other: Emotion Focused Therapy applicationOther: scale form

Interventions

Participants in the intervention group will first be given face-to-face individual interviews to establish the therapeutic environment and relationship (Individual interviews are designed as orientation, diagnosis and planning stages, 30-minute interviews). Then, three intervention stages (40-minute, group therapy) will be applied and the last session will be both intervention (post-test application) and termination stage (completion of emotion-focused therapy application). After the individual interviews, individuals will be included in 3 intervention sessions as group training. It is planned that each group will have at least 4 and at most 6 people. If the specified number cannot be reached, the study will continue until the specified number is reached.

Also known as: Emotion Focused Therapy, psychoeducation, psychotherapy
intervention group to which emotion-focused therapy will be applied

Emotion-focused therapy contributes to the treatment compliance and functionality of psychiatric patients.

Control group, where no intervention will be made and only research questionnaires will be appliedintervention group to which emotion-focused therapy will be applied

Eligibility Criteria

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

You may qualify if:

  • Being diagnosed with Bipolar Disorder (I, II) and receiving maintenance treatment and being in remission,
  • Receiving standard drug treatment (mood stabilizer, antipsychotic or antidepressant) and standard clinical follow-up for bipolar disorder,
  • Not having hearing, comprehension and vision problems,
  • Being able to read and write,
  • Being patients who agree to participate in the study.

You may not qualify if:

  • Having another psychotic disorder in addition to the diagnosis of bipolar disorder,
  • Being newly diagnosed with bipolar disorder and being in the acute phase,
  • Wanting to leave the study,
  • Not agreeing to participate in the study,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla Eğitim Ve Araştırma Hastanesi

Multiple Locations, Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (1)

  • Shahar B. New Developments in Emotion-Focused Therapy for Social Anxiety Disorder. J Clin Med. 2020 Sep 10;9(9):2918. doi: 10.3390/jcm9092918.

    PMID: 32927706BACKGROUND

Related Links

MeSH Terms

Conditions

Directly Observed TherapyBipolar Disorder

Interventions

Emotion-Focused TherapyPsychotherapy

Condition Hierarchy (Ancestors)

Medication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorBipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research was designed as a single-blind randomized controlled trial (pre-test-post-test, control group, follow-up measurement) in an experimental setting.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 6, 2024

Study Start

May 21, 2025

Primary Completion

September 25, 2025

Study Completion

February 13, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

In this study, individual participant data will be anonymized by removing or coding all direct identifiers to ensure confidentiality and privacy. Identifiable information such as names, national ID numbers, and contact details will not be included in the dataset. Only de-identified data will be shared with other researchers. Shared data will be limited to demographic variables (e.g., age, gender), clinical characteristics (e.g., illness duration, episode history), and numerical scores from emotion awareness and emotional response scales. Free-text responses, interview records, and other potentially identifiable raw data will not be shared. Data sharing will be restricted to ethically approved scientific studies and will require appropriate data use agreements. The dataset will not be publicly available and will be provided only under controlled, restricted-access conditions.

Locations