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| Name | Class |
|---|---|
| Centre for Addiction and Mental Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change in scores from baseline to months 3, 6, and 12 |
| EuroQol-5 Dimensions |
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Inclusion Criteria for patient participants:
Exclusion Criteria for patient participants:
Family member/Carer participant inclusion criteria:
Family member/Carer participant exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ameer B Khoso | Contact | 021-35371084 | ameer.bukhsh@pill.org.pk |
| Name | Affiliation | Role |
|---|---|---|
| Omair Husain, MD | Centre for Addiction and Mental Health | Principal Investigator |
| Imran B Chaudhry, MD | Pakistan Institute of Living and Learning | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Civil hospital | Recruiting | Karachi | Sindh | 75600 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37328751 | Derived | 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. |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Researchers doing outcome assessment will be blind to treatment allocation
| 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. |
|
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. |
| 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 | 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 | 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 | 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 | Change in scores from baseline to months 3, 6, and 12 |
| Illness Perception Questionnaire | The IPQ is used to evaluate carer beliefs about schizophrenia | 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. | 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 | 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 | 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 | 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 | 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 | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Change in scores from baseline to 3, 6 and 12-month follow up |