An interventional study of CaCBT for psychosis and Culturally adapted Family Intervention (CulFI) for psychosis in Psychosis, sponsored by Pakistan Institute of Living and Learning. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Pakistan Institute of Living and Learning · Not applicable, Interventional, and Treatment
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:
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
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.
Exclusion Criteria for patient participants:
Family member/Carer participant inclusion criteria:
Family member/Carer participant exclusion criteria:
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 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
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.
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
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.
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.
Time frame: Change in scores from baseline to months 3, 6, and 12
Calgary Depression Scale for Schizophrenia
The CDSS is a 9-items scale which evaluates depression in individuals with psychosis. The minimum score is 0 and maximum 30.Higher scores indicate greater depressive severity
Time frame: Change in scores from baseline to months 3, 6, and 12
EuroQol-5 Dimensions
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). Higher score indicates better quality of life.
Time frame: Change in scores from baseline to months 3, 6, and 12
World Health Organization Disability Assessment Scale
It is a self-administered questionnaire based on 36 items that measures health and disability. The scoring has three steps: Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability
Time frame: Change in scores from baseline to months 3, 6, and 12
Schedule for Assessment of Insight
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
Time frame: Change in scores from baseline to months 3, 6, and 12
Experience of Caregiving Inventory
The ECI is a thorough measure that assesses the experiences of caring for a family member with severe mental illness
Time frame: Change in scores from baseline to months 3, 6, and 12
Carer Well-Being and Support
The CWS is an instrument to assess the wellbeing and support of a carer
Time frame: Change in scores from baseline to months 3, 6, and 12
Illness Perception Questionnaire
The IPQ is used to evaluate carer beliefs about schizophrenia
Time frame: Change in scores from baseline to months 3, 6, and 12
Generalized Anxiety Disorder
A 7-item scale measuring anxiety. Higher score indicates higher anxiety. Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.
Time frame: Change in scores from baseline to months 3, 6, and 12
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. PHQ-9 total score for the nine items ranges from 0 to 27. Higher score indicates greater depression severity
Time frame: Change in scores from baseline to months 3, 6, and 12
Cognitive Behaviour Therapy Rating Scale
Fidelity to the manuals of the interventions will be assessed via recorded sessions using 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
Therapists' adherence to the manuals of the interventions will be assessed via recorded sessions using 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)
This is a is a reliable and valid scale which is used to measure the compliance to psychosocial treatment of people with psychotic disorders
Time frame: Participants' compliance with psychosocial treatment will be assessed at end of intervention (3-months)
Treatment Adherence Rating Scale
This scale will be used to assess the antipsychotic medication adherence of participants
Time frame: Participants' adherence will be assessed at end of intervention at 3, 6 and 12 months
Session Attendance Log
A session log will be maintained for each participant to maintain record of attendance for each session of assigned intervention.
Time frame: Session attendance for each session for 3 months
The block design
The block design sub-test from the Wechsler Intelligence Scales will be sued to assess cognitive functioning. The higher score on the scale reflects better cognitive functioning
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
Matrix ReasoningTest
The matrix reasoning sub-test from the Wechsler Intelligence Scales will be used to assess visual information processing and abstract reasoning skills. Higher scores on the scale indicate better visual information processing and abstract reasoning skills.
Time frame: Change in scores from baseline to 3, 6 and 12 month follow up.
Picture Completion Test
The picture completion sub-test from the Wechsler Intelligence Scales measures measures visual perception, specifically, alertness to visual details. Higher score on this sub-scale indicate better cognitive skills in terms of visual perception.
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
Visual Puzzles Test
The Visual Puzzles sub-test from the Wechsler Intelligence Scales measures visual intelligence. Higher score on this sub-test indicates high visual intelligence.
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
The Oral Fluency test
This test measures the ability to evoke valid and distinct exemplars of a particular category. Higher score on this scale indicate better cognitive ability.
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
Memory for Design
The test examines visual recall of an individual. Higher score indicate better cognitive skills.
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
Coughlan Learning Task (verbal)
This test assesses verbal memory. Higher score on this test indicates better verbal memory.
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
Coughlan Learning Task (visual)
This test assesses visual memory. Higher score on this test indicates better visual memory.
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
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Pakistan Institute of Living and Learning