Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting

Official title

Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting: a Large Multi-center Randomised Controlled Trial

Overview

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: 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

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.

Interventions

• 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
• 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 rel

Primary outcome measures

• Positive and Negative Syndrome Scale [Time frame: Change in scores from baseline to months 3, 6, and 12]

Secondary outcome measures (12)

• Calgary Depression Scale for Schizophrenia [Time frame: Change in scores from baseline to months 3, 6, and 12]
• EuroQol-5 Dimensions [Time frame: Change in scores from baseline to months 3, 6, and 12]
• World Health Organization Disability Assessment Scale [Time frame: Change in scores from baseline to months 3, 6, and 12]
• Schedule for Assessment of Insight [Time frame: Change in scores from baseline to months 3, 6, and 12]
• Experience of Caregiving Inventory [Time frame: Change in scores from baseline to months 3, 6, and 12]
• Carer Well-Being and Support [Time frame: Change in scores from baseline to months 3, 6, and 12]
• Illness Perception Questionnaire [Time frame: Change in scores from baseline to months 3, 6, and 12]
• Generalized Anxiety Disorder [Time frame: Change in scores from baseline to months 3, 6, and 12]
• Patient Health Questionnaire (PHQ-9) [Time frame: Change in scores from baseline to months 3, 6, and 12]
• Cognitive Behaviour Therapy Rating Scale [Time frame: Fidelity will be measured after completion of the intervention ( at 3rd month)]
• Cognitive Therapy for Psychosis Adherence Scale [Time frame: Therapists' adherence will be measured after completion of the intervention ( at 3rd month)]
• The Psychosocial Treatment Compliance Scale (PTCS) [Time frame: Participants' compliance with psychosocial treatment will be assessed at end of intervention (3-months)]

Eligibility criteria

Inclusion Criteria for patient participants:

• Individuals of all genders aged over 18 years; diagnosis of schizophrenia confirmed by Structured Clinical Interview for DSM (SCID) meeting DSM-5 criteria for schizophrenia, schizophreniform or schizoaffective psychosis
• 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

Exclusion Criteria for patient participants:

• Active DSM-5 substance use disorder (except nicotine or caffeine) or dependence within the last three months
• 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

Family member/Carer participant inclusion criteria:

• 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.

Family member/Carer participant exclusion criteria:

• Active DSM-5 substance use disorder
• Received psychological intervention within the past 3 months
• Unstable residential arrangements.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Civil hospital — Karachi

Publications

• 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 PMID 37328751

Identifiers

NCT: NCT05814913 · PILL/CAMH-CaCBT+CulFI-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗