NCT05420792

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

June 6, 2022

Last Update Submit

June 14, 2022

Conditions

Keywords

bipolar disorderInterpersonal and Social Rhythm Therapypsychiatric nursing

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 COMPARATOR

Peplau Interpersonal Relations based IPSRT will be applied to the intervention group

Behavioral: Peplau Interpersonal Relations based IPSRT will be applied to the intervention group

control group

NO INTERVENTION

the 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)

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

İzmir Katip Çelebi University Atatürk Eğitim ve Araştırma Hastanesi

Izmir, Karabağlar, Turkey (Türkiye)

Location

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.

  • 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.

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Şeyda Dülgerler

    Ege University Nursing

    PRINCIPAL INVESTIGATOR

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

Locations