- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06721858
Effects of Emotion-focused Therapy (EFT) on Mood Awareness and Emotional Reactivity in Bipolar Patients Awareness and Emotional Reactivity (EFT)
Effects of Emotion-focused Therapy (EFT) on Mood Awareness and Emotional Reactivity in Bipolar Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bipolar disorder is defined as a mental disorder characterized by depression, hypomania, and manic episodes, regardless of order, with periods of remission between these episodes or where the symptoms are thought to be felt at very mild levels, requiring regular follow-up and treatment, and causing serious impairments in family, interpersonal, and occupational functioning (Yeloğlu & Hocaoğlu, 2017; Jung et al, 2020). The World Health Organization (WHO) has reported bipolar disorder as one of the top 10 diseases that cause disability among all diseases. Treatment compliance rates in bipolar disorder vary between 20% and 60%. The average prevalence rate of non-adherence to treatment is 41% (Zhang, 2020). The exact cause of this disease, which is known to cause high mortality and morbidity, has been associated with biological and psychosocial factors (Öztürk, 2020). This disorder is classified as subtypes under the title of "Bipolar Disorder and Related Disorders" in the "Diagnostic and Statistical Manual of Mental Disorders/DSM-5". These classifications are as follows; bipolar disorder I, bipolar disorder II, cyclothymia disorder, substance/medication-induced bipolar and related disorder, other specified and not otherwise specified bipolar and related disorder (Atagün & Oral, 2021). When all bipolar disorders are taken into account, it has been reported that the lifetime prevalence is approximately 7.8%. In order to prevent the recurrence of bipolar disorder, providing patients with functionality, improving their compliance with treatment and quality of life, and providing them with stress coping skills are among the most important goals of treatment (Özdel et al., 2021). Patients may experience serious disruptions in their lives due to suicide attempts, substance abuse, poor functionality, decreased academic success, poor interpersonal communication, and repeated hospitalizations. One of the conditions that most affects the course of the disease in bipolar disorder and causes relapses is treatment compliance. Treatment compliance includes individuals accepting and implementing the recommended treatments for their illness, going to check-ups, controlling their emotions, continuing treatment programs, using medications as often and at the dose they are prescribed, participating in psychosocial support treatment methods applied in addition to pharmacotherapy and making healthy behavioral changes (individual coping strategies, skills training, emotional management training, awareness training, etc.) (Moreira et al., 2017).
Emotional reactivity is one of the important factors affecting the treatment compliance process in bipolar patients, where mood swings are frequent (Miller & Black, 2020). 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 endurance shown until reaching the basic emotion (Seçer et al., 2013). Emotions that usually create emotional reactions are emotions such as anger, anxiety, stress, and hurt (Du et al., 2018). Even individuals without a psychiatric diagnosis can sometimes have difficulty controlling such emotions when they encounter them (Demissie et al., 2018). 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. Individuals who are aware of their emotions can have an easier time recognizing their emotions, as their emotional attention and emotional clarity will increase (Gökdağ & Yüvrük, 2022). Patients' compliance with treatment positively affects the course of the disease and supports increased 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 functionality (Subic-Wrana et al., 2014; Miziou et al., 2015). Studies have also shown that providing patients with psychosocial interventions aimed at understanding their emotions is important for increasing the effectiveness of bipolar disorder treatment and for the disease process to progress positively (Watson & Dodd, 2017). Emotion-focused therapy, which is among the interventions that can be applied, is an intervention strategy based on patients' recognition of emotions, development of emotional awareness and understanding, early detection of warning signs and mood changes, increasing compliance with treatment, and providing information about the disease (Demissie et al., 2018). Emotion-focused therapy (EFT) is a psychotherapy method based on the emotion-centered humanistic approach theory, which processes the awareness of emotions, acceptance, expression, regulation and transformation of emotions in the therapeutic process (Morriss et al., 2016). Thanks to the given emotion-focused therapy, individuals can gain awareness about their emotions and increase their functionality by developing individual skills in directing their reactions (Çam, & Çuhadar, 2013). Another therapy that is at the forefront of the theories that constitute the theoretical framework of DOT is the person-centered theory. According to this theory, the cause of psychological problems arises from the inconsistency between the individual's "self-concept" and "experience". When the inconsistency between the self-concept (I am strong) and experience (feeling weak) prevents awareness, the person reacts to this by worrying. Again, according to this theory, when the individual is guided by "self-actualization", which is the most basic tendency of human life, the person becomes reliable, believable and constructive. DOT argues that emotional change should be placed at the center of therapy in order to achieve permanent change and therefore adopts the modern emotion theory (Uslu & Gizir 2019). DOT suggests that emotions have an adaptive potential on their own if activated, and adopts the view that emotions help clients reorganize their negative self-experiences and change problematic emotional states and interactions. The main purpose of DOT is to strengthen the self, regulate affect, and create new meanings (Greenberg, 2016). Since there is no standardized emotion-focused therapy application that can be applied to patients with bipolar disorder in psychiatric clinics, it is thought that a well-designed therapy application can increase compliance with treatment and increase the level of functionality, thus maintaining the well-being of patients and reducing health care costs. This study was planned to examine the effect of emotion-focused therapy applied to patients with bipolar diagnosis on the patients' mood awareness and emotional reactivity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Muğla
-
Multiple Locations, Muğla, Turkey (Türkiye), 48000
- Muğla Eğitim Ve Araştırma Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Inclusion criteria are being between the ages of 18-65,
- 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.
Exclusion Criteria:
- 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,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control group, where no intervention will be made and only research questionnaires will be applied
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.
|
Emotion-focused therapy contributes to the treatment compliance and functionality of psychiatric patients.
|
|
Experimental: intervention group to which emotion-focused therapy will be applied
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.
|
Emotion-focused therapy contributes to the treatment compliance and functionality of psychiatric patients.
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EFFECTS OF EMOTION-FOCUSED THERAPY APPLIED TO PATIENTS WITH BIPOLAR DIAGNOSIS ON THEIR MOOD AWARENESS AND EMOTIONAL REACTIVITY
Time Frame: 6 month
|
By creating randomized controlled groups, emotion-focused therapy will be applied between the control and intervention groups.
|
6 month
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bipolar and Related Disorders
- Mental Disorders
- Mood Disorders
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Patient Compliance
- Patient Acceptance of Health Care
- Medication Adherence
- Bipolar Disorder
- Directly Observed Therapy
- Behavioral Disciplines and Activities
- Psychotherapy
- Emotion-Focused Therapy
Other Study ID Numbers
- 2024-KAEK-23/ 49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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