PsychosisCaPSINCT05814913
Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting
A study testing CaCBT for psychosis and Culturally adapted Family Intervention (CulFI) for psychosis in people with Psychosis, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosis
- What is being tested?
- CaCBT for psychosis and Culturally adapted Family Intervention (CulFI) for psychosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Civil hospital
Karachi, Sindh, 75600
Tayyeba Kiran, 0923328262142, tayyebakiran@gmail.com
About this study
Official title: Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting: a Large Multi-center Randomised Controlled Trial
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.
Read more
Secondary Aims:
- 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.
- 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.
- To determine the comparative effect of CaCBT and CulFI in improving patient and carer related outcomes in individuals with FEP in Pakistan.
- To estimate the economic impact of delivering culturally appropriate psychosocial interventions in low-resource settings
- 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
Read the 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.
- Conditions
- Psychosis
- Being tested
- CaCBT for psychosis, Culturally adapted Family Intervention (CulFI) for psychosis
- Keywords
- First Episode Psychosis, LAMIC, Family Intervention, CBT, Paksitan
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaCBT for psychosisBehavioural
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
Culturally adapted Family Intervention (CulFI) for psychosisBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in scores from baseline to months 3, 6, and 12
Secondary outcomes (22)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change in scores from baseline to months 3, 6, and 12
Illness Perception Questionnaire
The IPQ is used to evaluate carer beliefs about schizophrenia
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change in scores from baseline to 3, 6 and 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start15 Apr 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Responsible party
- Sponsor
- Investigators
- Omair Husain, MD, Principal investigator, Centre for Addiction and Mental HealthImran B Chaudhry, MD, Principal investigator, Pakistan Institute of Living and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814913
- Sponsor's protocol ID
- PILL/CAMH-CaCBT+CulFI-002
- Acronym
- CaPSI
- Status last verified
- Dec 2024
- First submitted
- 3 Apr 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 for a large multi-center RCT. BMC Psychiatry. 2023 Jun 16;23(1):444. doi: 10.1186/s12888-023-04904-8.
PubMed 37328751
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting: a Large Multi-center Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05814913
- Acronym / sponsor ID
- CaPSI / PILL/CAMH-CaCBT+CulFI-002
- Conditions
- Psychosis
- Keywords
- First Episode Psychosis, LAMIC, Family Intervention, CBT, Paksitan
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- To determine the comparative effect of CaCBT and CulFI in improving patient and carer related outcomes in individuals with FEP in Pakistan.
- To estimate the economic impact of delivering culturally appropriate psychosocial interventions in low-resource settings
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CaCBT for psychosis | Experimental | Behavioral: CaCBT for psychosisCaCBT 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 |
| CulFI Intervention | Experimental | Behavioral: Culturally adapted Family Intervention (CulFI) for psychosisCulFI 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaCBT for psychosisThe 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 | Behavioural | CaCBT for psychosis |
| Culturally adapted Family Intervention (CulFI) for psychosisCulFI 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. | Behavioural | CulFI Intervention |
Primary outcome
Positive and Negative Syndrome Scale
Time frame: Change in scores from baseline to months 3, 6, and 12
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.
22 secondary outcomes
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)
Treatment Adherence Rating Scale
Time frame: Participants' adherence will be assessed at end of intervention at 3, 6 and 12 months
Session Attendance Log
Time frame: Session attendance for each session for 3 months
The block design
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
Matrix ReasoningTest
Time frame: Change in scores from baseline to 3, 6 and 12 month follow up.
Picture Completion Test
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
Visual Puzzles Test
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
The Oral Fluency test
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
Memory for Design
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
Coughlan Learning Task (verbal)
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
Coughlan Learning Task (visual)
Time frame: Change in scores from baseline to 3, 6 and 12-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Derived from this study: PubMed 37328751Husain 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omair Husain, MD principal investigator
Centre for Addiction and Mental Health
Imran B Chaudhry, MD principal investigator
Pakistan Institute of Living and Learning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaCBT for psychosis and Culturally adapted Family Intervention (CulFI) for psychosis in people with Psychosis, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ameer B Khoso (021-35371084, ameer.bukhsh@pill.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (time frame: Change in scores from baseline to months 3, 6, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05814913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.