Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting: a Large Multi-center Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psychosis
- Sponsor
- Pakistan Institute of Living and Learning
- Enrollment
- 390
- Locations
- 1
- Primary Endpoint
- Positive and Negative Syndrome Scale
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Primary Aims:
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:
- 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.
- 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.
- To determine the comparative effect of CaCBT and CulFI in improving patient and carer related outcomes in individuals with FEP in Pakistan.
- To estimate the economic impact of delivering culturally appropriate psychosocial interventions in low-resource settings
- 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
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 and community settings in ten centres (i.e. Karachi, Lahore, Rawalpindi, Hyderabad, Qambar Shahdakot, Shaheed Benazirabad, Sukkur, Peshawar, Quetta and Multan). 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Positive and Negative Syndrome Scale
Time Frame: 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. The higher the score the greater symptoms severity. potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale.
Secondary Outcomes
- Calgary Depression Scale for Schizophrenia(Change in scores from baseline to months 3, 6, and 12)
- EuroQol-5 Dimensions(Change in scores from baseline to months 3, 6, and 12)
- World Health Organization Disability Assessment Scale(Change in scores from baseline to months 3, 6, and 12)
- Schedule for Assessment of Insight(Change in scores from baseline to months 3, 6, and 12)
- Experience of Caregiving Inventory(Change in scores from baseline to months 3, 6, and 12)
- Carer Well-Being and Support(Change in scores from baseline to months 3, 6, and 12)
- Illness Perception Questionnaire(Change in scores from baseline to months 3, 6, and 12)
- Generalized Anxiety Disorder(Change in scores from baseline to months 3, 6, and 12)
- Patient Health Questionnaire (PHQ-9)(Change in scores from baseline to months 3, 6, and 12)
- Cognitive Behaviour Therapy Rating Scale(Fidelity will be measured after completion of the intervention ( at 3rd month))
- Cognitive Therapy for Psychosis Adherence Scale(Therapists' adherence will be measured after completion of the intervention ( at 3rd month))
- The Psychosocial Treatment Compliance Scale (PTCS)(Participants' compliance with psychosocial treatment will be assessed at end of intervention (3-months))
- Treatment Adherence Rating Scale(Participants' adherence will be assessed at end of intervention at 3, 6 and 12 months)
- Session Attendance Log(Session attendance for each session for 3 months)
- The block design(Change in scores from baseline to 3, 6 and 12-month follow up)
- Matrix ReasoningTest(Change in scores from baseline to 3, 6 and 12 month follow up.)
- Picture Completion Test(Change in scores from baseline to 3, 6 and 12-month follow up)
- Visual Puzzles Test(Change in scores from baseline to 3, 6 and 12-month follow up)
- The Oral Fluency test(Change in scores from baseline to 3, 6 and 12-month follow up)
- Memory for Design(Change in scores from baseline to 3, 6 and 12-month follow up)
- Coughlan Learning Task (verbal)(Change in scores from baseline to 3, 6 and 12-month follow up)
- Coughlan Learning Task (visual)(Change in scores from baseline to 3, 6 and 12-month follow up)