AzTrials
AzTrials

Therapy, Directly ObservedEFTNCT06721858

Effects of Emotion-focused Therapy (EFT) on Mood Awareness and Emotional Reactivity in Bipolar Patients Awareness and Emotional Reactivity

A study testing Emotion Focused Therapy application and scale form in people with Therapy, Directly Observed, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Therapy, Directly Observed
What is being tested?
Emotion Focused Therapy application and scale form
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 May 2025to 13 Feb 2026
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

  • 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.

Who cannot join

  • 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,

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Muğla Eğitim Ve Araştırma Hastanesi

    Multiple Locations, Muğla, 48000

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Emotion-focused Therapy (EFT) on Mood Awareness and Emotional Reactivity in Bipolar Patients

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.

Read the 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.

Being tested
Emotion Focused Therapy application, scale form
Keywords
emotion focused therapy, emotional reactivity, mood awareness, bipolar disorder
Medical subject headings
Directly Observed Therapy, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotion Focused Therapy applicationOther

    Also called Emotion Focused Therapy, psychoeducation, psychotherapy

    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.

  • scale formOther

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

Study groups in NCT06721858
Study groupRoleWhat they receive
Control group, where no intervention will be made and only research questionnaires will be appliedPlacebo comparatorThe 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.
Receives: Other: scale form
intervention group to which emotion-focused therapy will be appliedExperimentalParticipants 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.
Receives: Other: Emotion Focused Therapy application; Other: scale form

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2024
  2. Study start21 May 2025
  3. Primary completion25 Sep 2025
  4. Study completion13 Feb 2026

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The research was designed as a single-blind randomized controlled trial (pre-test-post-test, control group, follow-up measurement) in an experimental setting.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06721858
Sponsor's protocol ID
2024-KAEK-23/ 49
Acronym
EFT
Status last verified
Apr 2026
First submitted
28 Nov 2024
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 32927706

Questions about this trial

What is this clinical trial studying?

A study testing Emotion Focused Therapy application and scale form in people with Therapy, Directly Observed, run by Muğla Sıtkı Koçman University 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 4 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 22 Apr 2026. 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. Some participants in this study may receive a placebo. 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?

EFFECTS OF EMOTION-FOCUSED THERAPY APPLIED TO PATIENTS WITH BIPOLAR DIAGNOSIS ON THEIR MOOD AWARENESS AND EMOTIONAL REACTIVITY (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06721858, which also lists 1 linked publication.

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 22 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in