The Key to Emotional BalanceNCT07208721
The Key to Emotional Balance
A study testing The Key to Emotional Balance in people with The Key to Emotional Balance, run by TC Erciyes University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- The Key to Emotional Balance
- What is being tested?
- The Key to Emotional Balance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Having a diagnosis of bipolar I or bipolar II disorder according to the DSM-5.
- Being between 18 and 65 years of age.
- Being literate and having the cognitive capacity to participate in written questionnaires.
- Being in a stable mood/remission (neither severely manic nor severely depressed) at the start of the study.
- Being on medication or willing and able to comply with treatment.
- Voluntarily agreeing to participate in the study and signing the informed consent form.
Who cannot join
- Being in an episode of acute mania or severe depression.
- Having a diagnosis of another serious psychiatric disorder such as schizophrenia, schizoaffective disorder, severe anxiety disorder, or obsessive-compulsive disorder (OCD).
- Cognitive impairments, such as dementia, severe cognitive impairment, or mental retardation, that would prevent participation in the recommended therapy.
- Individuals with a history of substance abuse within the last 6 months or ongoing active substance use.
- Individuals who have attempted suicide within the last 6 months or who currently have suicidal thoughts (patients at high risk of suicide).
- Refusal to attend regular therapy sessions or severe resistance to psychotherapy.
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- Individuals who are not compliant with recommended medication for bipolar disorder.
- Serious medical problems or chronic conditions that would prevent recommended psychotherapy (e.g., uncontrolled epilepsy or serious cardiovascular disease).
- Inability to speak Turkish sufficiently to understand the questionnaires and therapeutic interventions or difficulty communicating.
- Not attending psychoeducation sessions more than three times or not completing any of the pretest and posttest measures of the data collection forms.
- Relapse of disease during the study and inability to comply with the program.
- Participating in any other program while the study is ongoing.
About this study
Official title: The Key to Emotional Balance: The Effect of a Positive Psychotherapy-Based Balance Model on Emotion Regulation, Recovery, and Life Purpose in Bipolar Disorder
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
- Being tested
- The Key to Emotional Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Key to Emotional BalanceBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental | 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 Receives: Behavioral: The Key to Emotional Balance |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulty in Emotion Regulation
The short form of the scale was developed by Bjureberg and colleagues (2016). The scale is a 5-point Likert-type scale consisting of 16 items. It includes five subscales. These are: difficulty in making sense of emotions when experiencing negative emotions (clarity), difficulty in performing goal-directed behaviors when experiencing negative emotions (goals), difficulty in applying emotion regulation strategies when experiencing negative emotions (strategies), difficulty in accepting negative emotions (non-acceptance), and difficulty in maintaining impulse control when experiencing negative emotions (drive). The validity and reliability study of the scale, which consists of the sub-dimensions of goals (questions 3, 7, 15), strategies (questions 5, 6, 12, 14, 16), non-acceptance (questions 9, 10, 13, openness (questions 1, 2) and impulse (questions 4, 8, 11), was carried out by Yiğit and Güzey-Yiğit (2017) in our country. It is observed that the Cronbach's Alpha internal consistency co
Measured: Timeframe: Pre-test, 8 weeks later
Secondary outcomes (2)
Recovery Assessment Scale:
The scale was developed by Corrigan and colleagues (2004) to measure various sub-dimensions of recovery from the perspective of individuals diagnosed with mental illness and adapted to Turkish by Güler and Gurkan (2019). The scale consists of 24 items and 5 sub-dimensions. It is a 5-point Likert-type scale. The sub-dimensions of the scale include: self-confidence and hope sub-dimension: items 7, 8, 9, 10, 11, 12, 13, 14, and 21; help-seeking behavior sub-dimension: items 18, 19, and 20; goal and achievement orientation sub-dimension: items 1, 2, 3, 4, and 5; trust in others sub-dimension: items 6, 22, 23, and 24; and coping with symptoms sub-dimension: items 15, 16, and 17. There are no reverse items in the scale. Possible scores range from 24 to 120. The total scale score is the sum of the scores obtained from each item. While there is no cutoff score, it is assumed that improvement scores increase as the total scale score increases. Cronbach's alpha values for the scale subscales
Measured: Timeframe: Pre-test, 8 weeks later
Determining Life Goals in the Context of Positive Psychotherapy (PPBYABÖ):
This scale was developed by Eryılmaz (2012). It measures whether individuals have determined their life goals in three areas. The scale is a nine-item, four-point Likert-type scale with three subdimensions: achievement (career) goals, relationship goals, and body (sense) goals. The Body Goals dimension of the scale includes individuals' goals related to physical relaxation; the Relationship Goals dimension includes individuals' goals such as determining the characteristics of their future spouses and having children. The Success Goals dimension includes individuals' career goals. Items 1, 2, and 3 are related to achievement (career) goals; items 4, 5, and 6 are related to relationship goals; and items 7, 8, and 9 are related to body (sense) goals. The lowest score possible on the scale is 9, and the highest score is 36. The Cronbach Alpha value of the achievement (career) goals sub-dimension of the scale is 0.85, the Cronbach Alpha value of the relationship goals dimension is 0.73, an
Measured: Timeframe: Pre-test, 8 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Key to Emotional BalanceStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Eda Albayrak Günday, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208721
- Sponsor's protocol ID
- The Key to Emotional Balance
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Key to Emotional Balance: The Effect of a Positive Psychotherapy-Based Balance Model on Emotion Regulation, Recovery, and Life Purpose in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT07208721
- Acronym / sponsor ID
- The Key to Emotional Balance
- Conditions
- The Key to Emotional Balance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: The Key to Emotional BalanceThe 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 | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having a diagnosis of bipolar I or bipolar II disorder according to the DSM-5.
- Being between 18 and 65 years of age.
- Being literate and having the cognitive capacity to participate in written questionnaires.
- Being in a stable mood/remission (neither severely manic nor severely depressed) at the start of the study.
- Being on medication or willing and able to comply with treatment.
Key exclusion criteria (12 listed)
- Being in an episode of acute mania or severe depression.
- Having a diagnosis of another serious psychiatric disorder such as schizophrenia, schizoaffective disorder, severe anxiety disorder, or obsessive-compulsive disorder (OCD).
- Cognitive impairments, such as dementia, severe cognitive impairment, or mental retardation, that would prevent participation in the recommended therapy.
- Individuals with a history of substance abuse within the last 6 months or ongoing active substance use.
- Individuals who have attempted suicide within the last 6 months or who currently have suicidal thoughts (patients at high risk of suicide).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Key to Emotional BalanceThe 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 | Behavioural | Experimental |
Primary outcome
Difficulty in Emotion Regulation
Time frame: Timeframe: Pre-test, 8 weeks later
The short form of the scale was developed by Bjureberg and colleagues (2016). The scale is a 5-point Likert-type scale consisting of 16 items. It includes five subscales. These are: difficulty in making sense of emotions when experiencing negative emotions (clarity), difficulty in performing goal-directed behaviors when experiencing negative emotions (goals), difficulty in applying emotion regulation strategies when experiencing negative emotions (strategies), difficulty in accepting negative emotions (non-acceptance), and difficulty in maintaining impulse control when experiencing negative emotions (drive). The validity and reliability study of the scale, which consists of the sub-dimensions of goals (questions 3, 7, 15), strategies (questions 5, 6, 12, 14, 16), non-acceptance (questions 9, 10, 13, openness (questions 1, 2) and impulse (questions 4, 8, 11), was carried out by Yiğit and Güzey-Yiğit (2017) in our country. It is observed that the Cronbach's Alpha internal consistency co
2 secondary outcomes
Recovery Assessment Scale:
Time frame: Timeframe: Pre-test, 8 weeks later
Determining Life Goals in the Context of Positive Psychotherapy (PPBYABÖ):
Time frame: Timeframe: Pre-test, 8 weeks later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The Key to Emotional Balance in people with The Key to Emotional Balance, run by TC Erciyes University.
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 12 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: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
Difficulty in Emotion Regulation (time frame: Timeframe: Pre-test, 8 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2025.