Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
Feasibility RCT of the Efficacy of a Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
Aim:
To assess the Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan
Design:
Randomized Control Trial
Setting:
Psychiatric Departments of different Hospitals in Karachi.
Participants:
A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and treatment as usual arm.
Intervention:
Culturally Adapted psychological intervention for bipolar disorder
Outcome measure:
- Acceptance of intervention in terms of attending session and dropouts
- Knowledge and attitudes towards bipolar disorder
調査の概要
詳細な説明
The purpose of the study is to test Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan
Primary Objectives :
- To determine effectiveness of educational intervention in terms of patient Satisfaction with overall care, knowledge and attitudes to bipolar disorder and medication adherence.
To assess feasibility in terms of
- Recruitment
- Using instruments that will be used to assess recurrence rate in the main study (BDI, YMRS and obtaining prospective hospitalisation and medication data)
- acceptability of a culturally adapted bipolar group education package
- To allow 'fine tuning' of culturally adapted bipolar group education package (this will partly be achieved by using the SEMI at study entry)
The Participants will be recruited from psychiatric department of different hospitals.
They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirty six participants will be recruited in the pilot study and divided equally into two arms. This will ensure that, even after loss to follow-up, we will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf) .Randomization will be carried out by the on offsite statistician. This will provide a reliable geographically remote service. For intervention group twelve sessions of psychoeducation will be provided by trained research clinician during the period of three months. Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested patients will be offered psychoeducation.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Sindh
-
Karachi、Sindh、パキスタン
- Dow University of Health Sciences
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Diagnosis of DSM IV Bipolar disorder
- Currently stable (YMRS <8, BDI<12)
- Age 18 to 65 years.
- Participants engaged with the mental health services since last 6 months.
- Able to give written informed consent.
- Resident of trial catchments area
- Ability to speak Urdu /Punjabi
Exclusion Criteria:
- Substance or alcohol dependent (i.e., those who fulfill the criteria for dependence according to DSM IV criteria)
- Inability to engage fully in the psychotherapy (due to cognitive impairment)
- Actively suicidal
- Any major psychiatric illness other than bipolar disorder
研究計画
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 |
|---|---|
|
介入なし：コントロール
「通常通りの治療」群に無作為に割り付けられる患者は、通常のケアを受けます
|
|
|
実験的：Intervention
Psycho-education Sessions will be offered weekly basis
|
Psycho-education Sessions will be offered weekly basis
|
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 |
|---|---|---|
|
Young Mania Rating Scale(YMRS)
時間枠：three months
|
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms
|
three months
|
|
Knowledge and attitudes
時間枠：three months
|
Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire
|
three months
|
|
Beck's Depression Inventory Scale (BDI)
時間枠：three months
|
The BDI is a measure of depression severity and has been used in several previous studies in Pakistan and is validated for use in Urdu.
|
three months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Medication adherence
時間枠：three months
|
Self-reported Measure of Medication adherence
|
three months
|
|
Visual Analogue Scale
時間枠：three months
|
Patient satisfaction with overall care
|
three months
|
|
Short Explanatory Model Interview
時間枠：three months
|
used to elicit beliefs of mental illness
|
three months
|
協力者と研究者
捜査官
- 主任研究者：Imran Chaudhry, MD、University of Manchester
- 主任研究者：Nusrat Husain, MD、Pakistan Institute of Learning and Living, University of Manchester
- 主任研究者：Farooq Naeem, MRCPsych、Pakistan Institute of Learning and Living, University of Southampton
- 主任研究者：Munir Hamirani, FCPS、Abbasi Shaheed Hospital
- 主任研究者：Raza Ur Rehman, FCPS、Dow University of Health Sciences
- 主任研究者：Ajmal kazm、Pakistan Institute of Living and Learning
- 主任研究者：Muhammad I Husain, MRCPsych、Camden and Islington NHS foundation trust
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PSY-BPD-03
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