Clinical trial NCT05814913: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Keywords: First Episode Psychosis
LAMIC
Family Intervention
CBT
Paksitan
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
First posted: 2023-04-18
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Positive and Negative Syndrome Scale
timeFrame: Change in scores from baseline to months 3, 6, and 12
Secondary outcomes:
measure: Calgary Depression Scale for Schizophrenia
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: EuroQol-5 Dimensions
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: World Health Organization Disability Assessment Scale
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Schedule for Assessment of Insight
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Experience of Caregiving Inventory
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Carer Well-Being and Support
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Illness Perception Questionnaire
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Generalized Anxiety Disorder
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Cognitive Behaviour Therapy Rating Scale
timeFrame: Fidelity will be measured after completion of the intervention ( at 3rd month)
measure: Cognitive Therapy for Psychosis Adherence Scale
timeFrame: Therapists' adherence will be measured after completion of the intervention ( at 3rd month)
measure: The Psychosocial Treatment Compliance Scale (PTCS)
timeFrame: Participants' compliance with psychosocial treatment will be assessed at end of intervention (3-months)
measure: Treatment Adherence Rating Scale
timeFrame: Participants' adherence will be assessed at end of intervention at 3, 6 and 12 months
measure: Session Attendance Log
timeFrame: Session attendance for each session for 3 months
measure: The block design
timeFrame: Change in scores from baseline to 3, 6 and 12-month follow up
measure: Matrix ReasoningTest
timeFrame: Change in scores from baseline to 3, 6 and 12 month follow up.
measure: Picture Completion Test
timeFrame: Change in scores from baseline to 3, 6 and 12-month follow up
measure: Visual Puzzles Test
timeFrame: Change in scores from baseline to 3, 6 and 12-month follow up
measure: The Oral Fluency test
timeFrame: Change in scores from baseline to 3, 6 and 12-month follow up
measure: Memory for Design
timeFrame: Change in scores from baseline to 3, 6 and 12-month follow up
measure: Coughlan Learning Task (verbal)
timeFrame: Change in scores from baseline to 3, 6 and 12-month follow up
measure: Coughlan Learning Task (visual)
timeFrame: Change in scores from baseline to 3, 6 and 12-month follow up
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Civil hospital
state: Sindh
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Omair Husain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Living and Learning
name: Imran B Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
References: