A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder
16 juli 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
120
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: "BalancingMySwing"
Psychoeducational Program "BalancingMySwing" for bipolar disorder
|
Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy
|
|
Övrig: treatment as usual (TAU)
Patients received treatment as usual
|
Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes from Baseline Social Rhythm through Study Completion, at the 3rd and the 6th month after study completion
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Esther C Lin, National Cheng Kung University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 augusti 2015
Primärt slutförande (Faktisk)
31 juli 2018
Avslutad studie (Faktisk)
31 december 2018
Studieregistreringsdatum
Först inskickad
8 juli 2019
Först inskickad som uppfyllde QC-kriterierna
11 juli 2019
Första postat (Faktisk)
16 juli 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juli 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2019
Senast verifierad
1 juli 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NCKU
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
We plan to use only for data analysis and publication without any recognized individual identification.
Tidsram för IPD-delning
Data analysis and publication will have occur at the end of the study, and continue after 7 months of the summary data are published.
Kriterier för IPD Sharing Access
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.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ANALYTIC_CODE
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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