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

NCT05814913 | Recruiting DMC

• 1 other identifier: PILL/CAMH-CaCBT+CulFI-002
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.To determine the comparative effect of CaCBT and CulFI in improving patient and carer related outcomes in individuals with FEP in Pakistan.
4. 4.To estimate the economic impact of delivering culturally appropriate psychosocial interventions in low-resource settings
5. 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.

Conditions

Psychosis

Keywords

First Episode Psychosis; LAMIC; Family Intervention; CBT; Paksitan

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale

  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.

  Change in scores from baseline to months 3, 6, and 12

Secondary Outcomes (22)

• 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

Study Arms (3)

CaCBT for psychosis

EXPERIMENTAL

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

CulFI Intervention

EXPERIMENTAL

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

Treatment as Usual (TAU)

NO INTERVENTION

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.

Interventions

CaCBT for psychosis BEHAVIORAL

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

CaCBT for psychosis

Culturally adapted Family Intervention (CulFI) for psychosis BEHAVIORAL

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.

CulFI Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• Centre for Addiction and Mental Health: collaborator

Study Sites (1)

Civil hospital

Karachi, Sindh, 75600, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 37328751 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Omair Husain, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

• Imran B Chaudhry, MD

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ameer B Khoso

CONTACT

021-35371084; ameer.bukhsh@pill.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers doing outcome assessment will be blind to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start: April 15, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)