- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02210390
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Sindh
-
Karachi, Sindh, Pakistan
- Dow University of Health Sciences
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Controllo
I pazienti che saranno randomizzati al braccio "trattamento come al solito" riceveranno cure di routine
|
|
Sperimentale: Intervention
Psycho-education Sessions will be offered weekly basis
|
Psycho-education Sessions will be offered weekly basis
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Young Mania Rating Scale(YMRS)
Lasso di tempo: 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
Lasso di tempo: three months
|
Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire
|
three months
|
Beck's Depression Inventory Scale (BDI)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Medication adherence
Lasso di tempo: three months
|
Self-reported Measure of Medication adherence
|
three months
|
Visual Analogue Scale
Lasso di tempo: three months
|
Patient satisfaction with overall care
|
three months
|
Short Explanatory Model Interview
Lasso di tempo: three months
|
used to elicit beliefs of mental illness
|
three months
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Imran Chaudhry, MD, University of Manchester
- Investigatore principale: Nusrat Husain, MD, Pakistan Institute of Learning and Living, University of Manchester
- Investigatore principale: Farooq Naeem, MRCPsych, Pakistan Institute of Learning and Living, University of Southampton
- Investigatore principale: Munir Hamirani, FCPS, Abbasi Shaheed Hospital
- Investigatore principale: Raza Ur Rehman, FCPS, Dow University of Health Sciences
- Investigatore principale: Ajmal kazm, Pakistan Institute of Living and Learning
- Investigatore principale: Muhammad I Husain, MRCPsych, Camden and Islington NHS foundation trust
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PSY-BPD-03
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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