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A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder

16. Juli 2019 aktualisiert von: Esther Ching-Lan Lin, National Cheng Kung University

A Randomized Controlled Trial of a Psychoeducational Program"BalancingMySwing" for Patients With Bipolar Disorder

The psychoeducation BalancingMySwing (BMS) program has been developed manually and its feasibility has been tested in our previous study. This 3-year research project aimed to further examine the immediate and lasted effects of BMS program for BD, and to assess its knowledge dissemination and the transferability of its evidence-based practice across multiple sites.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The psychoeducation BalancingMySwing (BMS) program has been developed manually and its feasibility has been tested in our previous study. This 3-year research project aimed to further examine the immediate and lasted effects of BMS program for bipolar disorders (BD), and to assess its knowledge dissemination and the transferability of its evidence-based practice across multiple sites.

During the first 2 years, a randomized controlled trial was conducted. Patients diagnosed with BD were recruited and 104 patients were randomly assigned to treatment as usual (TAU) or to 8 BMS sessions. A battery of three outcome indicators-social rhythm, illness perception, and symptom severity-were used to examine the effects of the two groups at baseline, after intervention, and every 3 months until half year. In addition, a pre- and post-test quasi-experimental study combined with qualitative design was used to assess the translational feasibility of BMS and to explore related barriers and facilitators of implementing BMS in clinical settings in the third year. Nurses from 4 Hospitals received the BMS training, and patients with BD received the BMS translated in practice were recruited.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

120

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Had a DSM-IV(Diagnostic and Statistical Manual of Mental Disorders-IV) diagnosis of BP-I or II confirmed through the interviews using the Chinese version of the Modified Schedule of Affective Disorder and Schizophrenia-Lifetime.
  • Able to speak and read Taiwanese or Taiwanese Mandarin Chinese
  • Had signed a written consent form
  • Agreed to accept the following medication therapy during the study: a mood stabilizer (valproic acid or lithium salts), an antidepressant, second generation antipsychotics, anxiolytics (lorazepam [< 8 mg/day]), and medicine to counteract side effects: extrapyramidal symptoms, tachycardia, and involuntary movement of smooth muscles in the gastrointestinal tract, urinary tract, lungs, etc.

Exclusion Criteria:

  • Required immediate hospitalization
  • Had any comorbidity with substance abuse or were current alcohol or drug abusers, or had been in the previous year
  • Had been diagnosed with an organic psychosis, a neurodegenerative disease, a personality disorder, or impaired cognitive abilities

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: "BalancingMySwing"
Psychoeducational Program "BalancingMySwing" for bipolar disorder
Verhalten: Psychoeducational Program "BalancingMySwing"
Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy
Sonstiges: treatment as usual (TAU)
Patients received treatment as usual
Verhalten: Psychoeducational Program "BalancingMySwing"
Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes from Baseline Social Rhythm through Study Completion, at the 3rd and the 6th month after study completion
Zeitfenster: At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
Social Rhythm Metric-5 items (SRM-5)-- The total scores range from 0 to 5; the higher the score the more regularly the activities occur.
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
Changes from Baseline Illness Perception through Study Completion, at the 3rd and the 6th month after study completion
Zeitfenster: At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
Illness Perception Questionnaire-Revised (IPQ-R) has 3 subscales. The first subscale (identity) determines whether patients attribute specific symptoms to BD (total score: range = 0-10). The second subscale assesses 25 items of illness perceptions. The third subscale assessed the causes of BD. The second and third subscales are rated on a 5-point Likert scale (range: 1~5). A higher score on each item indicates a stronger belief in that illness perception.
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
Changes from Baseline Manic Symptom through Study Completion, at the 3rd and the 6th month after study completion
Zeitfenster: At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
Young Mania Rating Scale (YMRS)--The total score of the 11-item YMRS is the summation of the 2 subscales (range: 0-60), and could be divided into four levels: 0 to 12 means remission, 13 to 19 means minimal severe, > 20 as diagnosed with mania based on DSM-IV(Diagnostic and Statistical Manual of Mental Disorders, IV) criteria, and over 25 showed obvious symptoms.
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
Changes from Baseline Depressive Symptom through Study Completion, at the 3rd and the 6th month after study completion
Zeitfenster: At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
Hamilton Depression Rating Scale (HDRS)--The total score of the 17-item HDRS is the summation of the 2 subscales(ranged: 0- 52), and could be divided into four levels: 0-7 means remission, 8-13 means mild severe, 14-22 means moderate severe, and > 23 means very severe.
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Cheng Kung University

Ermittler

  • Hauptermittler: Esther C Lin, National Cheng Kung University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. August 2015

Primärer Abschluss (Tatsächlich)

31. Juli 2018

Studienabschluss (Tatsächlich)

31. Dezember 2018

Studienanmeldedaten

Zuerst eingereicht

8. Juli 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Juli 2019

Zuerst gepostet (Tatsächlich)

16. Juli 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juli 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Juli 2019

Zuletzt verifiziert

1. Juli 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NCKU

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

We plan to use only for data analysis and publication without any recognized individual identification.

IPD-Sharing-Zeitrahmen

Data analysis and publication will have occur at the end of the study, and continue after 7 months of the summary data are published.

IPD-Sharing-Zugriffskriterien

Only the research members in out research team can access individual participant data (IPD) and any additional supporting information and only for statistic data analysis and publication under the PI supervision. The PI will review all information shared to follow the research purpose.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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