The Key to Emotional Balance

NCT ID: NCT07208721

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-09-01

Brief Summary

This randomized controlled experimental study aimed to evaluate the effects of the Key to Emotional Balance (KBA) psychoeducational program, based on the Balance Model of Positive Psychotherapy (PPT), on indicators of emotion regulation difficulties, recovery, and purpose in life in adults with bipolar disorder. Intervention and control groups (n=37 each; total n=74) will be formed through simple random assignment. The intervention will consist of eight individual sessions, each lasting 40-50 minutes. Data will be collected using the Difficulty in Emotion Regulation, Recovery Assessment Scale, and the Life Goals Scale in the Context of PPT. Measurements will be conducted as a pretest and posttest.

Conditions

The Key to Emotional Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental

The Key to Emotional Balance (KBA) program consists of eight sessions, each lasting 40-50 minutes, and aims to help participants develop emotional balance. The first session introduces the individual, introduces group rules, provides information about the program, and supports the client in identifying and expressing their emotions. The second session encourages the client to assess their energy-time intensity in their current and future balance models and, if deviations occur, to restructure them. The third session will help participants recognize their abilities in coping with bipolar illness and its symptoms and to use these abilities effectively. They will also be encouraged to identify factors that hinder their ability to use their abilities and focus on their developed abilities. The fourth session will focus on developing a "positive" perspective, enabling them to approach bipolar illness and its symptoms from a positive perspective. The fifth session will support participants

Group Type: EXPERIMENTAL

The Key to Emotional Balance

Intervention Type: BEHAVIORAL

The Key to Emotional Balance (KBA) program consists of eight sessions, each lasting 40-50 minutes, and aims to help participants develop emotional balance. The first session introduces the individual, introduces group rules, provides information about the program, and supports the client in identifying and expressing their emotions. The second session encourages the client to assess their energy-time intensity in their current and future balance models and, if deviations occur, to restructure them. The third session will help participants recognize their abilities in coping with bipolar illness and its symptoms and to use these abilities effectively. They will also be encouraged to identify factors that hinder their ability to use their abilities and focus on their developed abilities. The fourth session will focus on developing a "positive" perspective, enabling them to approach bipolar illness and its symptoms from a positive perspective. The fifth session will support participants

Control

After an explanation of the study is provided to the individuals in the control group, verbal and written consent will be obtained from those who agree to participate in the study. Individuals who agree to participate will be administered an "Introductory Information Form," the "Difficulties in Emotion Regulation," the "Recovery Assessment Scale," and the Life Goals Scale in the Context of Positive Psychotherapy. Patients in this group will not receive any treatment other than their routine treatment. At the end of the study, individuals will be administered the "Difficulties in Emotion Regulation," the "Recovery Assessment Scale," and the Life Goals Scale in the Context of Positive Psychotherapy. Subsequently, the individuals in the control group will undergo all of the same sessions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The Key to Emotional Balance

The Key to Emotional Balance (KBA) program consists of eight sessions, each lasting 40-50 minutes, and aims to help participants develop emotional balance. The first session introduces the individual, introduces group rules, provides information about the program, and supports the client in identifying and expressing their emotions. The second session encourages the client to assess their energy-time intensity in their current and future balance models and, if deviations occur, to restructure them. The third session will help participants recognize their abilities in coping with bipolar illness and its symptoms and to use these abilities effectively. They will also be encouraged to identify factors that hinder their ability to use their abilities and focus on their developed abilities. The fourth session will focus on developing a "positive" perspective, enabling them to approach bipolar illness and its symptoms from a positive perspective. The fifth session will support participants

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Having a diagnosis of bipolar I or bipolar II disorder according to the DSM-5.

2. Being between 18 and 65 years of age.

3. Being literate and having the cognitive capacity to participate in written questionnaires.

4. Being in a stable mood/remission (neither severely manic nor severely depressed) at the start of the study.

5. Being on medication or willing and able to comply with treatment.

6. Voluntarily agreeing to participate in the study and signing the informed consent form.

Exclusion Criteria

1. Being in an episode of acute mania or severe depression.

2. Having a diagnosis of another serious psychiatric disorder such as schizophrenia, schizoaffective disorder, severe anxiety disorder, or obsessive-compulsive disorder (OCD).

3. Cognitive impairments, such as dementia, severe cognitive impairment, or mental retardation, that would prevent participation in the recommended therapy.

4. Individuals with a history of substance abuse within the last 6 months or ongoing active substance use.

5. Individuals who have attempted suicide within the last 6 months or who currently have suicidal thoughts (patients at high risk of suicide).

6. Refusal to attend regular therapy sessions or severe resistance to psychotherapy.

7. Individuals who are not compliant with recommended medication for bipolar disorder.

8. Serious medical problems or chronic conditions that would prevent recommended psychotherapy (e.g., uncontrolled epilepsy or serious cardiovascular disease).

9. Inability to speak Turkish sufficiently to understand the questionnaires and therapeutic interventions or difficulty communicating.

1. Not attending psychoeducation sessions more than three times or not completing any of the pretest and posttest measures of the data collection forms.

2. Relapse of disease during the study and inability to comply with the program.

3. Participating in any other program while the study is ongoing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Eda Albayrak Günday

Research Assistant Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

The Key to Emotional Balance

Identifier Type: -

Identifier Source: org_study_id