A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder
2019年7月16日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
120
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的："BalancingMySwing"
Psychoeducational Program "BalancingMySwing" for bipolar disorder
|
Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy
|
|
他の：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes from Baseline Social Rhythm through Study Completion, at the 3rd and the 6th month after study completion
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Esther C Lin、National Cheng Kung University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年8月1日
一次修了 (実際)
2018年7月31日
研究の完了 (実際)
2018年12月31日
試験登録日
最初に提出
2019年7月8日
QC基準を満たした最初の提出物
2019年7月11日
最初の投稿 (実際)
2019年7月16日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月17日
QC基準を満たした最後の更新が送信されました
2019年7月16日
最終確認日
2019年7月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
We plan to use only for data analysis and publication without any recognized individual identification.
IPD 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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