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Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan

21. december 2016 opdateret af: Pakistan Institute of Living and Learning

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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 :

  1. To determine effectiveness of educational intervention in terms of patient Satisfaction with overall care, knowledge and attitudes to bipolar disorder and medication adherence.

  2. 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
  3. 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Dow University of Health Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Styring
Patienter, der vil blive randomiseret til "behandling som sædvanlig"-armen, vil modtage rutinemæssig behandling
Eksperimentel: Intervention
Psycho-education Sessions will be offered weekly basis
Adfærdsmæssigt: Psycho education
Psycho-education Sessions will be offered weekly basis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Young Mania Rating Scale(YMRS)
Tidsramme: 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
Tidsramme: three months
Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire
three months
Beck's Depression Inventory Scale (BDI)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medication adherence
Tidsramme: three months
Self-reported Measure of Medication adherence
three months
Visual Analogue Scale
Tidsramme: three months
Patient satisfaction with overall care
three months
Short Explanatory Model Interview
Tidsramme: three months
used to elicit beliefs of mental illness
three months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pakistan Institute of Living and Learning

Samarbejdspartnere

University of Manchester
Dow University of Health Sciences
Abbasi Shaheed Hospital

Efterforskere

  • Ledende efterforsker: Imran Chaudhry, MD, University of Manchester
  • Ledende efterforsker: Nusrat Husain, MD, Pakistan Institute of Learning and Living, University of Manchester
  • Ledende efterforsker: Farooq Naeem, MRCPsych, Pakistan Institute of Learning and Living, University of Southampton
  • Ledende efterforsker: Munir Hamirani, FCPS, Abbasi Shaheed Hospital
  • Ledende efterforsker: Raza Ur Rehman, FCPS, Dow University of Health Sciences
  • Ledende efterforsker: Ajmal kazm, Pakistan Institute of Living and Learning
  • Ledende efterforsker: Muhammad I Husain, MRCPsych, Camden and Islington NHS foundation trust

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2012

Primær færdiggørelse (Faktiske)

1. maj 2015

Studieafslutning (Faktiske)

1. maj 2015

Datoer for studieregistrering

Først indsendt

5. august 2014

Først indsendt, der opfyldte QC-kriterier

5. august 2014

Først opslået (Skøn)

6. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PSY-BPD-03

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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