The Effect of Interpersonal Relationships and Social Rhythm Therapy Individuals With Bipolar Disorder
NCT ID: NCT05420792
Last Updated: 2022-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
34 participants
INTERVENTIONAL
2021-08-01
2022-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study was planned as a follow-up study in a quantitative, randomized controlled experimental design, aiming to determine the effectiveness of Peplau's Interpersonal Relations theory-based IPSRT applied to individuals with bipolar disorder to determine the effect on biological rhythm, interpersonal relationships and relapse frequencies. Pre-intervention pre-test, post-intervention post-test and follow-up scheme will be used. To carrying out of this study, first of all, intervention and control groups will be formed by randomization according to gender and bipolar type (I-II), using the Introductory Information Form, Young Mania Rating and Hamilton Depression Rating Scales from individuals with bipolar disorder registered to the Community Mental Health Service (CMHS). As a pre-test (Introductory Information Form, Young Mania Rating Scale, Hamilton Depression Rating Scale, Biological Rhythm Assessment Interview, Interpersonal Competence Scale) to the intervention and control groups, Peplau Interpersonal Relations based IPSRT will be applied to the intervention group, and the control group will be given a CMHS and will also continue the treatment. IPSRT will take 40-45 minutes twice in a week and will be conducted in 10-12 individual meetings in total. Immediately, 1 month and 3 months after the interviews, post-tests will be applied to the intervention and control groups With this study, the biological rhythms of IPSRT individuals based on Peplau Interpersonal Relationship Theory in bipolar disorder will be regulated and the frequency of relapse will decrease. In addition, individuals with bipolar disorder, which is one of the lifelong mental illnesses that cause stigmatization, will continue their lives in the community, their functionality will increase in their work life, school life and social life, and hospitalization will decrease
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Psychosocial Therapy Plus Maintenance Pharmacotherapy for Treating Bipolar Disorder
NCT00227968
Early Intervention for Youth at High Risk for Bipolar Disorder
NCT04815239
Pilot Study of Interpersonal and Social Rhythm Therapy for Subthreshold Bipolar
NCT01520129
Interpersonal and Social Rhythm Therapy Enter the Brief Title for Protocol IRB 09-003781>
NCT01037283
Early Assessment and Intervention for Adolescents at Risk for Bipolar Disorder
NCT03203707
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
With this study, the biological rhythms of IPSRT individuals based on Peplau Interpersonal Relationship Theory in bipolar disorder will be regulated and the frequency of relapse will decrease. In addition, individuals with bipolar disorder, which is one of the lifelong mental illnesses that cause stigmatization, will continue their lives in the community, their functionality will increase in their work life, school life and social life, and hospitalization will decrease
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
intervention group
Peplau Interpersonal Relations based IPSRT will be applied to the intervention group
Peplau Interpersonal Relations based IPSRT will be applied to the intervention group
IPSRT based on peplau Interpersonal Relations theory will be applied to the intervention group. First of all, information about the study will be given. An informed consent form will be filled and a history will be taken from the patient. With the Life Events Chart, past attacks and life events, interpersonal relations will be compared. Interpersonal Circle will be made to better understand the individual and relationships. A Joint Study Plan, which summarizes the disease history, life events, and interpersonal circle, will be created and presented to the patient in summary form. The patient will be given psychoeducation about his illness, drugs and social rhythms. A Social Rhythm Metric (SRM) will be created and monitored throughout therapy to assess their daily routine. Early warning signs of impending attacks will be discussed, managing symptoms, situations that may disrupt social rhythm will be determined (travel, vacation, moving, changing job)
control group
the control group will be given a Community Mental Health Center and will also continue the treatment
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peplau Interpersonal Relations based IPSRT will be applied to the intervention group
IPSRT based on peplau Interpersonal Relations theory will be applied to the intervention group. First of all, information about the study will be given. An informed consent form will be filled and a history will be taken from the patient. With the Life Events Chart, past attacks and life events, interpersonal relations will be compared. Interpersonal Circle will be made to better understand the individual and relationships. A Joint Study Plan, which summarizes the disease history, life events, and interpersonal circle, will be created and presented to the patient in summary form. The patient will be given psychoeducation about his illness, drugs and social rhythms. A Social Rhythm Metric (SRM) will be created and monitored throughout therapy to assess their daily routine. Early warning signs of impending attacks will be discussed, managing symptoms, situations that may disrupt social rhythm will be determined (travel, vacation, moving, changing job)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Those who agreed to participate in the research
* Those who are at a level that can understand scales and forms with the competence to carry out individual interviews
* Individuals who are open to communication and cooperation and have no language problems
Exclusion Criteria
* Individuals with a diagnosis of schizoaffective.
* Those who want to quit their job and leave
* Those who cannot adapt, those who have communication problems
* Those who did not attend at least 3 interviews of IPT-SRT
* 12 points or higher from the Young Mania Rating Scale
* A score of 18 or higher on the Hamilton Depression Scale
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ege University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yeliz Aktas
PhD Student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Şeyda Dülgerler
Role: PRINCIPAL_INVESTIGATOR
Ege University Nursing
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
İzmir Katip Çelebi University Atatürk Eğitim ve Araştırma Hastanesi
Izmir, Karabağlar, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Goldstein TR, Fersch-Podrat R, Axelson DA, Gilbert A, Hlastala SA, Birmaher B, Frank E. Early intervention for adolescents at high risk for the development of bipolar disorder: pilot study of Interpersonal and Social Rhythm Therapy (IPSRT). Psychotherapy (Chic). 2014 Mar;51(1):180-9. doi: 10.1037/a0034396. Epub 2013 Dec 30.
Crowe M, Inder M, Douglas K, Carlyle D, Wells H, Jordan J, Lacey C, Mulder R, Beaglehole B, Porter R. Interpersonal and Social Rhythm Therapy for Patients With Major Depressive Disorder. Am J Psychother. 2020 Mar 1;73(1):29-34. doi: 10.1176/appi.psychotherapy.20190024. Epub 2019 Nov 22.
Mizushima H. [Psychoeducation and interpersonal and social rhythm therapy for bipolar disorder]. Seishin Shinkeigaku Zasshi. 2011;113(9):880-5. Japanese.
Crowe M, Porter R, Inder M, Carlyle D, Luty S, Lacey C, Frampton C. Clinical Effectiveness Trial of Adjunctive Interpersonal and Social Rhythm Therapy for Patients With Bipolar Disorder. Am J Psychother. 2020 Sep 1;73(3):107-114. doi: 10.1176/appi.psychotherapy.20190035. Epub 2020 Apr 20.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Ege University Nursing
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.