Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting
NCT ID: NCT05814913
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
390 participants
INTERVENTIONAL
2024-04-15
2026-12-31
Brief Summary
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To determine the clinical efficacy of Culturally adapted Cognitive Behavioral Therapy (CaCBT) and Culturally adapted Family Intervention (CulFI) compared to Treatment As Usual (TAU) on reducing overall symptoms of psychosis in patients with First Episode Psychosis (FEP) in Pakistan.
Secondary Aims:
1. To determine the efficacy of CaCBT and CulFI compared to TAU on positive and negative symptoms of psychosis, general psychopathology, depressive symptoms, quality of life, general functioning, and insight in patients with FEP in Pakistan.
2. To determine the efficacy of CaCBT and CulFI compared to TAU on improving carer experience, carer wellbeing, carer illness attitudes and symptoms of depression and anxiety in family and carers of patients with FEP in Pakistan.
3. To determine the comparative effect of CaCBT and CulFI in improving patient and carer related outcomes in individuals with FEP in Pakistan.
4. To estimate the economic impact of delivering culturally appropriate psychosocial interventions in low-resource settings
5. To explore delivery and reach of each intervention, tolerability of intervention components, acceptability of interventions, understanding mechanism of change and developing an understanding of barriers and facilitators to future adoption using process evaluation.
Study design and setting:
This will be a multi-centre, assessor masked, individual, three-arm randomised controlled trial (RCT).
Sample Size:
The study aims to recruit a total of N=390 participants with FEP
Detailed Description
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Consented participants meeting eligibility criteria will be randomised in a 1:1:1 allocation to CaCBT + TAU, CulFI + TAU or TAU alone. Participants in CaCBT intervention group will receive 12-weekly one-to-one sessions. Participants in CulFI group will receive 10-weekly one-to-one sessions. Each CaCBT and CulFI session will last for approximately 1 hour. Sessions will be delivered by trained psychologists who will receive regular weekly supervision to maintain fidelity. Assessments will be carried out at baseline, months 3, 6, and 12 by trained, blinded assessors. . Process evaluation will help to build the implementation knowledge base for proposed interventions across study settings. We will conduct economic evaluations (i.e., the cost-effectiveness and cost-utility analyses) of the CaCBT and CulFI interventions, as add-on to TAU.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CaCBT for psychosis
CaCBT is a culturally adapted psychosocial intervention for people with early psychosis that comprises of 12 sessions. These sessions are conducted individually on a weekly basis and last 45-60 minutes
CaCBT for psychosis
The CaCBT intervention is based on the intervention manual developed by David Kingdon and Douglas Turkington, and culturally adapted by our group. CaCBT aims to take a collaborative approach to gaining an understanding of the symptoms
CulFI Intervention
CulFI is a culturally adapted psychosocial intervention delivered over 10 sessions of 40-60 minutes, weekly for the first 8 weeks and fortnightly for the remaining 4 weeks. Sessions are delivered to patients and their carers, though patient participation in sessions is not necessary.
Culturally adapted Family Intervention (CulFI) for psychosis
CulFI intervention comprises of Family psychoeducation; cognitive-behavioural skills training for stress-management, coping and problem solving; crisis intervention and suicide risk management; relapse prevention; education and support regarding the family environment, including communication training. The components are designed to facilitate an understanding about psychosis, the emotional impact of the illness on family relationships, to promote more adaptive coping strategies and minimize relapse risk.
Treatment as Usual (TAU)
TAU will be ascertained by the participant's treating physician. Research staff will record the nature and intensity of TAU delivered to each participant over a period of 3 months.
No interventions assigned to this group
Interventions
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CaCBT for psychosis
The CaCBT intervention is based on the intervention manual developed by David Kingdon and Douglas Turkington, and culturally adapted by our group. CaCBT aims to take a collaborative approach to gaining an understanding of the symptoms
Culturally adapted Family Intervention (CulFI) for psychosis
CulFI intervention comprises of Family psychoeducation; cognitive-behavioural skills training for stress-management, coping and problem solving; crisis intervention and suicide risk management; relapse prevention; education and support regarding the family environment, including communication training. The components are designed to facilitate an understanding about psychosis, the emotional impact of the illness on family relationships, to promote more adaptive coping strategies and minimize relapse risk.
Eligibility Criteria
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Inclusion Criteria
* Scored at least 4 on the PANSS delusions or hallucinations items, or at least 5 on suspiciousness, persecution, or grandiosity items
* stable on medication for the past four weeks
* in contact with mental health services
* within 3 years of diagnosis
* able to demonstrate the capacity to provide informed consent to take part in the study
* potential participants must have a carer or relative who is also willing to participate in the study to be eligible
* Living with or spending at least 10 hours per week in face-to-face contact with an individual with early psychosis and assuming a caring role
* Age\>18 years
* Able to give informed written consent.
Exclusion Criteria
* A score of 5 or more on the PANSS conceptual disorganisation item
* Individuals who have received structured psychological intervention within the past 3 months
* Relevant CNS or other medical disorders that would impact participation
* Diagnosis of intellectual disability
* Unstable residential arrangements
* Active DSM-5 substance use disorder
* Received psychological intervention within the past 3 months
* Unstable residential arrangements.
18 Years
ALL
Yes
Sponsors
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Centre for Addiction and Mental Health
OTHER
Pakistan Institute of Living and Learning
OTHER
Responsible Party
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Principal Investigators
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Omair Husain, MD
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Imran B Chaudhry, MD
Role: PRINCIPAL_INVESTIGATOR
Pakistan Institute of Living and Learning
Locations
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Civil hospital
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Tayyeba Kiran
Role: primary
References
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Husain MO, Khoso AB, Kiran T, Chaudhry N, Husain MI, Asif M, Ansari M, Rajput AH, Dawood S, Naqvi HA, Nizami AT, Tareen Z, Rumi J, Sherzad S, Khan HA, Bhatia MR, Siddiqui KMS, Zadeh Z, Mehmood N, Talib U, de Oliveira C, Naeem F, Wang W, Voineskos A, Husain N, Foussias G, Chaudhry IB. Culturally adapted psychosocial interventions (CaPSI) for early psychosis in a low-resource setting: study protocol for a large multi-center RCT. BMC Psychiatry. 2023 Jun 16;23(1):444. doi: 10.1186/s12888-023-04904-8.
Other Identifiers
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PILL/CAMH-CaCBT+CulFI-002
Identifier Type: -
Identifier Source: org_study_id