Culturally Adapted Family Intervention For Psychosis
Pilot Study of Culturaly Adapted Family Intervention for Psychosis
Aim:
To assess the feasibility of culturally adapted Family Intervention for Psychosis.
Design:
Randomized Control Trial
Setting:
psychiatric department of different hospitals
Participants:
A total of 36 caregivers of Psychosis patients will be randomized to psychological Intervention and treatment as usual arm.
Intervention:
Culturally Adapted Family Intervention for Psychosis
Outcome measure:
Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care Well-Being & Support(CWS)
調査の概要
詳細な説明
The purpose of the study is to test the feasibility of culturally adaptive family intervention for Psychosis
Primary Objective :
- To test whether Pakistani families caring for someone with psychosis will engage with a model of family intervention which has been culturally adapted to meet their needs.
- To evaluate the acceptability of the intervention to the families who receive it and to gather feedback regarding any changes that might improve the intervention.
- To gain an impression of whether the intervention has the potential to address unmet psychological and social needs of the families and how this affects their levels of stress
the investigators will conduct a feasibility pilot study to test whether Pakistani families offered the intervention will want to receive it. 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 ten sessions of family intervention will be provided by trained research clinician during the period of three months. Relatives of Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested families will be offered family intervention
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,
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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:
- Living with or with at least 10 hours per week face to face contact with an individual with psychosis who has a caring role. Plus the individual with psychosis themselves.
- Individuals aged between 18-65.
- Resident of Karachi.
- Participant is able to give informed written consent.
Exclusion Criteria:
- Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).
Unstable residential arrangements such that the likelihood of being available for the duration of the trial is low.
.
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：ヘルスサービス研究
- 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：Family Intervention
Culturally Adapted Family intervention for Psychosis Sessions will be offered weekly basis
|
This 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component
他の名前：
|
|
介入なし：Control
Caregiver ' s Patients who will be randomized to the "treatment as usual" arm will receive routine care
|
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 |
|---|---|---|
|
Positive and Negative syndrome scale (PANSS)
時間枠：six months
|
The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.
|
six months
|
|
Experience of Care-giving inventory(ECI)
時間枠：six months
|
Commonly apply to persons who care for relative or friends With a serious mental illness
|
six months
|
|
Carer Wel-Being & Support(CWS)
時間枠：six months
|
A questionnaire for carers of people with a mental Health problem
|
six months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Family Questionnaire(FQ)
時間枠：six months
|
Find out the problem of caregiver for relative or friends With a serious mental illness.
|
six months
|
|
Insight rating scale
時間枠：six months
|
Assesses Improvement in insight
|
six months
|
|
Calgary Depression Scale for Schizophrenia
時間枠：six months
|
This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia
|
six months
|
|
Short Explanatory Model Interview
時間枠：six months
|
used to elicit beliefs of mental illness
|
six 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
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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