Bipolar DisorderNCT06101212
Predictors of Quality of Life in Bipolar Disorder
An observational study of Bipolar Disorder, run by Kubra TOHUMCU at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the predictive effects of impulsivity and coping skills on quality of life in patients with bipolar disorder. The sample of the study, which was carried out in a descriptive design, will consist of 80 patients who applied to Adıyaman Besni State Hospital Psychiatry Outpatient Clinic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- survey
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 5 Sep 2024
- Phase
- Observational
- 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
Study population: The descriptive study is planned to be conducted in Adıyaman Besni State Hospital between October 2023-February 2024. The population of the study will consist of individuals who applied to the Psychiatry Outpatient Clinic of Adıyaman Besni State Hospital on the dates of the study, who received outpatient treatment with the diagnosis of bipolar according to Diagnostic and Statistical Manual of Mental Disorders-5 and who were in the euthymic period according to the doctor's control. G* Power programme was used to calculate the sample size. The confidence interval α=0.05, the power of the test (1-β) 0.95, the effect size dz= 0.5 were calculated as a total of 54 people (presented in the appendix).
Who may be able to join
- Receiving outpatient treatment with a diagnosis of Bipolar Disorder according to DSM-5
- Being in euthymic mood according to the doctor's control at the time of the interview
- Having no problem in understanding and speaking Turkish
- Being in the 18-65 age group
Who cannot join
- Presence of serious sensory and cognitive impairment that would prevent answering the questionnaire
- Refusing to participate in the study after being informed
- Having another psychiatric diagnosis in addition to the diagnosis of bipolar disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Besni State Hospital
Besni, Adıyaman Province, 02000
About this study
Official title: The Predictive Effect of Impulsivity and Coping Skills on Quality of Life in Patients with Bipolar Disorder
This study was planned to determine the predictive effects of impulsivity and coping skills on quality of life in patients with bipolar disorder. The sample of the study, which was carried out in a descriptive design, will consist of 80 patients who applied to Adıyaman Besni State Hospital Psychiatry Outpatient Clinic with a diagnosis of bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 and who were in the euthymic period according to the doctor's control. It was planned to collect the data by applying the Personal Information Form prepared by the researchers, "Brief Quality of Life in Bipolar Disorder", "Barratt Impulsivity Scale -11 Short Form" and "Coping Attitudes Evaluation Scale". The data will be evaluated with descriptive statistics, Mann-Whitney U-test, Kruskal Wallis test, Pearson correlations and regression analyses using Statistical Package for the Social Sciences 22 software. Scale use and ethics committee permission were obtained from the responsible authors of the scales before the study.
Read the detailed description
Bipolar disorder is a chronic illness characterised by periods of illness and recovery, which can cause significant psychosocial impairment and disability. It affects more than 1% of the world population regardless of demographic characteristics such as ethnicity, nationality, socioeconomic status and is one of the leading causes of global disability. Bipolar disorder can cause serious cognitive and functional impairments and maintaining life with this disorder involves some difficulties for the individual. Functional impairments such as deterioration in family relationships, problems in work life and incompatibilities in social relationships negatively affect both the well-being and quality of life of the individual. Many individuals diagnosed with bipolar disorder have functional disorders that can cause low quality of life. Quality of life is recognised as an important outcome measure for the effectiveness of treatment of mental disorders. Compared to healthy individuals, the quality of life of patients with bipolar disorder is significantly impaired in both the euthymic and symptomatic periods. The ability to cope with difficulties is assumed to be a protective factor for quality of life. However, individuals diagnosed with bipolar disorder are exposed to more stressful events due to their illness and experience coping problems, including in the euthymic period. For these reasons, developing coping skills is among the targets in the treatment process of bipolar disorder. The stress coping strategies of these individuals may even affect the risk of suicide. Bipolar disorder is a serious illness that causes increased mortality, including death by suicide. Approximately 10-20% of these individuals end their lives and approximately one third of these individuals attempt suicide at least once.
Patients with bipolar disorder and previous suicide attempts have a worse quality of life. One of the most important factors associated with suicide and morbidity in bipolar disorder is impulsivity. Impulsivity, which can be defined as a predisposition to unplanned reactions to internal and external stimuli regardless of negative consequences and the absence of behavioural inhibition, is one of the clinical features of bipolar disorder. Although it is more common during manic episode, it can also be found in other mood phases. Bipolar disorder is characterised by high impulsivity even during recovery periods. Increased impulsivity is not only associated with suicide attempts but may also lead to functional impairment. Impulsive behaviours may cause long-term negative consequences in bipolar disorder that may affect quality of life. In the literature, it has been revealed that high impulsivity is associated with poor quality of life.
In the light of this information, this study aimed to determine the predictive effects of impulsivity and coping skills on quality of life in patients with bipolar disorder.
METHOD Sample The descriptive study is planned to be conducted in Adıyaman Besni State Hospital between October 2023-February 2024. The population of the study will consist of individuals who applied to the Psychiatry Outpatient Clinic of Adıyaman Besni State Hospital on the dates of the study, who received outpatient treatment with the diagnosis of bipolar according to Diagnostic and Statistical Manual of Mental Disorders-5 and who were in the euthymic period according to the doctor's control. G* Power programme was used to calculate the sample size. The confidence interval α=0.05, the power of the test (1-β) 0.95, the effect size dz= 0.5 were calculated as a total of 54 people (presented in the appendix).
The data will be collected by researcher Kubra Tohumcu through face-to-face interview technique. The patients constituting the sample of the study will be directed to the researcher by the outpatient clinic doctor. The data were planned to be collected by applying the "Personal Information Form", "Brief Quality of Life in Bipolar Disorder Scale", "Barratt Impulsivity Scale -11 Short Form" and "Coping Attitudes Evaluation Scale" prepared by the researchers.
Individual Information Form: This form, organised by the researchers, included 17 questions to determine the demographic information of the participants.
Brief Quality of Life in Bipolar Disorder Scale: Developed in 2010 by Michalak and Murray, the Turkish validity and reliability study of the scale was conducted by Gümüş et al. It is a 5-point Likert-type scale (1=Strongly Disagree, 5=Strongly Agree) consisting of a total of 7 items. The total score range that can be obtained from the scale varies between 12-60. Higher scores obtained from the scale indicate a better quality of life. Cronbach Alpha internal consistency coefficient was reported as .86.
Barratt Impulsivity Scale -11 Short Form: The scale consists of a total of 15 items and three subscales. These subscales are lack of planning, motor impulsivity and attention impulsivity. The items in the scale are evaluated using a 4-point Likert-type scale (1=rarely/never, 4=almost always/always). The high scores obtained from the scale indicate a high level of impulsivity. The Cronbach's alpha internal consistency coefficient for the entire scale adapted into Turkish was reported as .82, .80 for the failure to plan subscale, .70 for the motor impulsivity subscale, and .64 for attention impulsivity.
Coping Attitudes Rating Scale: The scale is a 4-point Likert-type scale (1=I Never Do This, 4=I Mostly Do This) consisting of 5 factors and 32 items. The score range to be obtained from the scale varies between 32-128, and the high score obtained from the scale indicates that the coping attitude level is high, while the low score obtained indicates that the coping attitude level is low. In the Turkish validity and reliability study of the scale, cronbach alpha value was .766.
Data analysis: The data of the study will be evaluated using descriptive statistical methods (frequency, mean), t-test, one way Analysis of Variance, correlation and regression analyses in Statistical Package for the Social Sciences 22 package programme.
- Conditions
- Bipolar Disorder
- Being tested
- survey
- Keywords
- Bipolar Disorder, Quality of life, Impulsivity, Coping attitudes
- Medical subject headings
- Bipolar Disorder, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
After obtaining the informed consent form, a 10-15 minute questionnaire will be applied to the patients included in the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Predictive Effect of Impulsivity on Quality of Life in Patients with Bipolar Disorder
The effect of impulsivity level on quality of life in bipolar disorder patients.
It was planned to collect the data by applying the "Personal Information Form", "Quality of Life in Bipolar Disorder Scale Short Form", "Barratt Impulsivity Scale -11 Short Form" and "Coping Attitudes Assessment Scale" prepared by the researchers. Barratt Impulsivity Scale minimum score=15 and maximum score=60. High scores indicate high impulsivity level of individuals. The results will be evaluated in line with the data obtained.
Measured: 15 October 2023-1 February 2024
Secondary outcomes (1)
The Predictive Effect of Coping Skills on Quality of Life in Patients with Bipolar Disorder
The effect of coping skill level on quality of life in patients with bipolar disorder.
It was planned to collect the data by applying the "Personal Information Form", "Quality of Life in Bipolar Disorder Scale Short Form", "Barratt Impulsivity Scale -11 Short Form" and "Coping Attitudes Assessment Scale" prepared by the researchers. The minimum score of the Coping Attitudes Assessment Scale=32 and the maximum score=128. High scores indicate that the coping attitude level of individuals is increased.
Measured: 15 October 2023-1 February 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start15 Nov 2023
- Primary completion10 Aug 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubra TOHUMCU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kubra TOHUMCU, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101212
- Sponsor's protocol ID
- Gaziantep University KBRTHMC
- Status last verified
- Sep 2024
- First submitted
- 1 Oct 2023
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Effect of Impulsivity and Coping Skills on Quality of Life in Patients with Bipolar Disorder
- ClinicalTrials.gov ID
- NCT06101212
- Acronym / sponsor ID
- Gaziantep University KBRTHMC
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Quality of life, Impulsivity, Coping attitudes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Kubra TOHUMCUUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 26 Oct 2023 (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 study was planned to determine the predictive effects of impulsivity and coping skills on quality of life in patients with bipolar disorder. The sample of the study, which was carried out in a descriptive design, will consist of 80 patients who applied to Adıyaman Besni State Hospital Psychiatry Outpatient Clinic with a diagnosis of bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 and who were in the euthymic period according to the doctor's control. It was planned to collect the data by applying the Personal Information Form prepared by the researchers, "Brief Quality of Life in Bipolar Disorder", "Barratt Impulsivity Scale -11 Short Form" and "Coping Attitudes Evaluation Scale". The data will be evaluated with descriptive statistics, Mann-Whitney U-test, Kruskal Wallis test, Pearson correlations and regression analyses using Statistical Package for the Social Sciences 22 software. Scale use and ethics committee permission were obtained from the responsible authors of the scales before the study.
Detailed description
Bipolar disorder is a chronic illness characterised by periods of illness and recovery, which can cause significant psychosocial impairment and disability. It affects more than 1% of the world population regardless of demographic characteristics such as ethnicity, nationality, socioeconomic status and is one of the leading causes of global disability. Bipolar disorder can cause serious cognitive and functional impairments and maintaining life with this disorder involves some difficulties for the individual. Functional impairments such as deterioration in family relationships, problems in work life and incompatibilities in social relationships negatively affect both the well-being and quality of life of the individual. Many individuals diagnosed with bipolar disorder have functional disorders that can cause low quality of life. Quality of life is recognised as an important outcome measure for the effectiveness of treatment of mental disorders. Compared to healthy individuals, the quality of life of patients with bipolar disorder is significantly impaired in both the euthymic and symptomatic periods. The ability to cope with difficulties is assumed to be a protective factor for quality of life. However, individuals diagnosed with bipolar disorder are exposed to more stressful events due to their illness and experience coping problems, including in the euthymic period. For these reasons, developing coping skills is among the targets in the treatment process of bipolar disorder. The stress coping strategies of these individuals may even affect the risk of suicide. Bipolar disorder is a serious illness that causes increased mortality, including death by suicide. Approximately 10-20% of these individuals end their lives and approximately one third of these individuals attempt suicide at least once.
Patients with bipolar disorder and previous suicide attempts have a worse quality of life. One of the most important factors associated with suicide and morbidity in bipolar disorder is impulsivity. Impulsivity, which can be defined as a predisposition to unplanned reactions to internal and external stimuli regardless of negative consequences and the absence of behavioural inhibition, is one of the clinical features of bipolar disorder. Although it is more common during manic episode, it can also be found in other mood phases. Bipolar disorder is characterised by high impulsivity even during recovery periods. Increased impulsivity is not only associated with suicide attempts but may also lead to functional impairment. Impulsive behaviours may cause long-term negative consequences in bipolar disorder that may affect quality of life. In the literature, it has been revealed that high impulsivity is associated with poor quality of life.
In the light of this information, this study aimed to determine the predictive effects of impulsivity and coping skills on quality of life in patients with bipolar disorder.
METHOD Sample The descriptive study is planned to be conducted in Adıyaman Besni State Hospital between October 2023-February 2024. The population of the study will consist of individuals who applied to the Psychiatry Outpatient Clinic of Adıyaman Besni State Hospital on the dates of the study, who received outpatient treatment with the diagnosis of bipolar according to Diagnostic and Statistical Manual of Mental Disorders-5 and who were in the euthymic period according to the doctor's control. G* Power programme was used to calculate the sample size. The confidence interval α=0.05, the power of the test (1-β) 0.95, the effect size dz= 0.5 were calculated as a total of 54 people (presented in the appendix).
The data will be collected by researcher Kubra Tohumcu through face-to-face interview technique. The patients constituting the sample of the study will be directed to the researcher by the outpatient clinic doctor. The data were planned to be collected by applying the "Personal Information Form", "Brief Quality of Life in Bipolar Disorder Scale", "Barratt Impulsivity Scale -11 Short Form" and "Coping Attitudes Evaluation Scale" prepared by the researchers.
Individual Information Form: This form, organised by the researchers, included 17 questions to determine the demographic information of the participants.
Brief Quality of Life in Bipolar Disorder Scale: Developed in 2010 by Michalak and Murray, the Turkish validity and reliability study of the scale was conducted by Gümüş et al. It is a 5-point Likert-type scale (1=Strongly Disagree, 5=Strongly Agree) consisting of a total of 7 items. The total score range that can be obtained from the scale varies between 12-60. Higher scores obtained from the scale indicate a better quality of life. Cronbach Alpha internal consistency coefficient was reported as .86.
Barratt Impulsivity Scale -11 Short Form: The scale consists of a total of 15 items and three subscales. These subscales are lack of planning, motor impulsivity and attention impulsivity. The items in the scale are evaluated using a 4-point Likert-type scale (1=rarely/never, 4=almost always/always). The high scores obtained from the scale indicate a high level of impulsivity. The Cronbach's alpha internal consistency coefficient for the entire scale adapted into Turkish was reported as .82, .80 for the failure to plan subscale, .70 for the motor impulsivity subscale, and .64 for attention impulsivity.
Coping Attitudes Rating Scale: The scale is a 4-point Likert-type scale (1=I Never Do This, 4=I Mostly Do This) consisting of 5 factors and 32 items. The score range to be obtained from the scale varies between 32-128, and the high score obtained from the scale indicates that the coping attitude level is high, while the low score obtained indicates that the coping attitude level is low. In the Turkish validity and reliability study of the scale, cronbach alpha value was .766.
Data analysis: The data of the study will be evaluated using descriptive statistical methods (frequency, mean), t-test, one way Analysis of Variance, correlation and regression analyses in Statistical Package for the Social Sciences 22 package programme.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The descriptive study is planned to be conducted in Adıyaman Besni State Hospital between October 2023-February 2024. The population of the study will consist of individuals who applied to the Psychiatry Outpatient Clinic of Adıyaman Besni State Hospital on the dates of the study, who received outpatient treatment with the diagnosis of bipolar according to Diagnostic and Statistical Manual of Mental Disorders-5 and who were in the euthymic period according to the doctor's control. G* Power programme was used to calculate the sample size. The confidence interval α=0.05, the power of the test (1-β) 0.95, the effect size dz= 0.5 were calculated as a total of 54 people (presented in the appendix).
Key inclusion criteria (4 listed)
- Receiving outpatient treatment with a diagnosis of Bipolar Disorder according to DSM-5
- Being in euthymic mood according to the doctor's control at the time of the interview
- Having no problem in understanding and speaking Turkish
- Being in the 18-65 age group
Key exclusion criteria (3 listed)
- Presence of serious sensory and cognitive impairment that would prevent answering the questionnaire
- Refusing to participate in the study after being informed
- Having another psychiatric diagnosis in addition to the diagnosis of bipolar disorder
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 |
|---|---|---|
| surveyAfter obtaining the informed consent form, a 10-15 minute questionnaire will be applied to the patients included in the study. | Other | – |
Primary outcome
The Predictive Effect of Impulsivity on Quality of Life in Patients with Bipolar Disorder
Time frame: 15 October 2023-1 February 2024
The effect of impulsivity level on quality of life in bipolar disorder patients. It was planned to collect the data by applying the "Personal Information Form", "Quality of Life in Bipolar Disorder Scale Short Form", "Barratt Impulsivity Scale -11 Short Form" and "Coping Attitudes Assessment Scale" prepared by the researchers. Barratt Impulsivity Scale minimum score=15 and maximum score=60. High scores indicate high impulsivity level of individuals. The results will be evaluated in line with the data obtained.
1 secondary outcome
The Predictive Effect of Coping Skills on Quality of Life in Patients with Bipolar Disorder
Time frame: 15 October 2023-1 February 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Kubra TOHUMCU 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 4 inclusion and 3 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 19 Sep 2024. 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. 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?
The Predictive Effect of Impulsivity on Quality of Life in Patients with Bipolar Disorder (time frame: 15 October 2023-1 February 2024). 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 19 Sep 2024.