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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Sindh
-
Karachi, Sindh, 파키스탄
- Dow University of Health Sciences
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 제어
"일반적인 치료" 부문에 무작위 배정될 환자는 일상적인 치료를 받게 됩니다.
|
|
|
실험적: Intervention
Psycho-education Sessions will be offered weekly basis
|
Psycho-education Sessions will be offered weekly basis
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Young Mania Rating Scale(YMRS)
기간: 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
기간: three months
|
Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire
|
three months
|
|
Beck's Depression Inventory Scale (BDI)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Medication adherence
기간: three months
|
Self-reported Measure of Medication adherence
|
three months
|
|
Visual Analogue Scale
기간: three months
|
Patient satisfaction with overall care
|
three months
|
|
Short Explanatory Model Interview
기간: three months
|
used to elicit beliefs of mental illness
|
three months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Imran Chaudhry, MD, University of Manchester
- 수석 연구원: Nusrat Husain, MD, Pakistan Institute of Learning and Living, University of Manchester
- 수석 연구원: Farooq Naeem, MRCPsych, Pakistan Institute of Learning and Living, University of Southampton
- 수석 연구원: Munir Hamirani, FCPS, Abbasi Shaheed Hospital
- 수석 연구원: Raza Ur Rehman, FCPS, Dow University of Health Sciences
- 수석 연구원: Ajmal kazm, Pakistan Institute of Living and Learning
- 수석 연구원: Muhammad I Husain, MRCPsych, Camden and Islington NHS foundation trust
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PSY-BPD-03
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