The Effect of Interpersonal Relationships and Social Rhythm Therapy Individuals With Bipolar Disorder
IPSRT
1 other identifier
interventional
34
1 country
1
Brief Summary
Interpersonal and Social Rhythm Therapy (IPSRT) is a type of psychotherapy that applies social rhythm theories in bipolar disorder. The purpose of IPSRT is to stabilize people's social routines (daily routines, sleep-wake balances), gain insight into the two-way relationship between interpersonal events and mood, and increase their satisfaction with social roles. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
June 6, 2022
CompletedFirst Posted
Study publicly available on registry
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedJune 15, 2022
June 1, 2022
1 year
June 6, 2022
June 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Young Mania rating scale scores
Change from baseline in Young Mania rating scale scores at 3 months
about 3 months
Biological Rhythm Interview Evaluation scores
Change in Biological Rhythm Interview Evaluation scores in 3 months compared to baseline
about 3 months
Hamilton Depression rating scale scores
Change from baseline in Hamilton Depression rating scale scores at 3 months
about 3 months
Study Arms (2)
intervention group
ACTIVE COMPARATORPeplau Interpersonal Relations based IPSRT will be applied to the intervention group
control group
NO INTERVENTIONthe control group will be given a Community Mental Health Center and will also continue the treatment
Interventions
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
You may qualify if:
- Adult individuals with bipolar disorder according to DSM-V diagnostic 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
You may not qualify if:
- Individuals with psychotic findings,
- 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
- points or higher from the Young Mania Rating Scale
- A score of 18 or higher on the Hamilton Depression Scale
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ege Universitylead
Study Sites (1)
İzmir Katip Çelebi University Atatürk Eğitim ve Araştırma Hastanesi
Izmir, Karabağlar, Turkey (Türkiye)
Related Publications (4)
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.
PMID: 24377402RESULTCrowe 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.
PMID: 31752508RESULTMizushima H. [Psychoeducation and interpersonal and social rhythm therapy for bipolar disorder]. Seishin Shinkeigaku Zasshi. 2011;113(9):880-5. Japanese.
PMID: 22117393RESULTCrowe 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.
PMID: 32306747RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Şeyda Dülgerler
Ege University Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
June 6, 2022
First Posted
June 15, 2022
Study Start
August 1, 2021
Primary Completion
August 1, 2022
Study Completion
October 1, 2022
Last Updated
June 15, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share