NCT06101212

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

9 months

First QC Date

October 1, 2023

Last Update Submit

September 6, 2024

Conditions

Keywords

Bipolar DisorderQuality of lifeImpulsivityCoping attitudes

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 October 2023-1 February 2024

Secondary Outcomes (1)

  • The Predictive Effect of Coping Skills on Quality of Life in Patients with Bipolar Disorder

    15 October 2023-1 February 2024

Interventions

surveyOTHER

After obtaining the informed consent form, a 10-15 minute questionnaire will be applied to the patients included in the study.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Besni State Hospital

Besni, Adıyaman Province, 02000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bipolar DisorderImpulsive Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 1, 2023

First Posted

October 26, 2023

Study Start

November 15, 2023

Primary Completion

August 10, 2024

Study Completion

September 5, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations