CaCBT+CulFI: Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting
Study Details
Study Description
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.
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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.
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To estimate the cost-effectiveness of CaCBT and CulFI in a low-resource setting (i.e., Pakistan) (if the RCT confirms the effectiveness of CaCBT and CulFI in FEP.
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Family Intervention (FI) and cognitive behavior therapy (CBT) are among the most efficacious psychosocial interventions to prevent relapse in schizophrenia. However, there is limited evidence from LMICs that supports the clinical efficacy and cost-effectiveness of delivering these psychosocial interventions to individuals with FEP. We aim to determine the clinical efficacy and cost-effectiveness of Culturally adapted Cognitive Behavioral Therapy (CaCBT) and Culturally adapted Family Intervention (CulFI) compared to TAU in reducing overall symptoms of psychosis in individuals with FEP in Pakistan. The study will include 390 participants with FEP from psychiatric units of hospitals in 8 centres including Karachi, Lahore, Multan, Rawalpindi, Peshawar, Hyderabad, Shaheed Benazirabad and Quetta in Pakistan.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Behavioral: 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
Other: Treatment as Usual
There is little if any provisions for psychosocial interventions for patients with FEP in Pakistan. Therefore, TAU is essentially the prescription of antipsychotic medication and follow-up appointments with the responsible physician.
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| Experimental: 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. |
Behavioral: 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.
Other: Treatment as Usual
There is little if any provisions for psychosocial interventions for patients with FEP in Pakistan. Therefore, TAU is essentially the prescription of antipsychotic medication and follow-up appointments with the responsible physician.
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| No Intervention: 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. |
Outcome Measures
Primary Outcome Measures
- Positive and Negative Syndrome Scale (PANSS): [Change in scores from baseline to months 3, 6, and 12]
The PANSS is a structured interview use to evaluate the prevalence and severity of the positive, negative and general psychiatric symptoms of schizophrenia.
Secondary Outcome Measures
- Calgary Depression Scale for Schizophrenia (CDSS) [Change in scores from baseline to months 3, 6, and 12]
The CDSS is a 9-items scale which evaluates depression in individuals with psychosis.
- Health-related quality of life measured using (EuroQol-5D (EQ- 5D) [Change in scores from baseline to months 3, 6, and 12]
EuroQol-5D (EQ- 5D) will be used to assess health-related quality of life over 5 dimensions (mobility, self-care, daily activities, pain-discomfort, anxiety and depression)
- World Health Organization Disability Assessment Scale (WHODAS) [Change in scores from baseline to months 3, 6, and 12]
It is a self-administered questionnaire based on 36 items that measures health and disability
- Schedule for Assessment of Insight [Change in scores from baseline to months 3, 6, and 12]
The Schedule for Assessment of Insight is used to evaluate the three different aspects of insight: treatment compliance, recognition of illness and re-labelling of psychotic phenomena
- Experience of Caregiving Inventory (ECI) [Change in scores from baseline to months 3, 6, and 12]
The ECI is a thorough measure that assesses the experiences of caring for a family member with severe mental illness
- Carer Well-Being and Support (CWS) [Change in scores from baseline to months 3, 6, and 12]
The CWS is an instrument to assess the wellbeing and support of a carer
- Illness Perception Questionnaire (IPQ) [Change in scores from baseline to months 3, 6, and 12]
The IPQ is used to evaluate carer beliefs about schizophrenia
- Generalized Anxiety Disorder (GAD-7) [Change in scores from baseline to months 3, 6, and 12]
A 7-item scale measuring anxiety
- Patient Health Questionnaire (PHQ-9) [Change in scores from baseline to months 3, 6, and 12]
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression
Eligibility Criteria
Criteria
Inclusion Criteria for patient participants:
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Individuals of all genders aged over 18 years with diagnosis of schizophrenia confirmed by Structured Clinical Interview for DSM-5 (SCID) criteria for schizophrenia, schizophreniform or schizoaffective psychosis
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Stable on medication for the past four weeks
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In contact with mental health services
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Within 3 years of diagnosis
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Able to demonstrate the capacity to provide informed consent to take part in the study
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Potential participants must have a carer or relative who is also willing to participate in the study to be eligible
Exclusion Criteria for patient participants:
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Active DSM-5 substance use disorder (except nicotine or caffeine) or dependence within the last three months
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Individuals who have received structured psychological intervention within the past 3 months
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Relevant CNS or other medical disorders that would impact participation
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Diagnosis of intellectual disability
Inclusion Criteria for carer/family member participants:
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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
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Age >18 years
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Able to give informed written consent
Exclusion Criteria for carer/family member participants:
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Active DSM-5 substance use disorder
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Received psychological intervention within the past 3 months
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Unstable residential arrangements.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pakistan Institute of Living and Learning
- Centre for Addiction and Mental Health
Investigators
- Principal Investigator: Omair Husain, MD, Centre for Addiction and Mental Health
- Principal Investigator: Imran B Chaudhry, MD, Pakistan Institute of Living and Learning
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PILL/CAMH-CaCBT+CulFI-002