Psychotic DisordersNCT07005388
Cultural Adaptation of Group CBT Psychosis Manual and Establishing Its Efficacy in Pakistan
A study testing Cognitive behavioral therapy for psychosis in people with Psychotic Disorders and Psychosis, run by Punjab Institute of Mental Health at 1 site in Pakistan.
Trial summary
A study aimed to culturally adapt group Cognitive Behavioral Therapy for psychosis (CBTp) for Pakistani patients with schizophrenia. Fifty inpatients from PIMH were randomly assigned to experimental (N=25) and control (N=25) groups. Both groups showed significant improvement in symptoms post-intervention (p\<0.05). Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Psychotic Disorders, Psychosis, Schizophrenia and Related Disorders
- What is being tested?
- Cognitive behavioral therapy for psychosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Oct 2021to 3 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A clinical diagnosis of schizophrenia or psychotic disorder for at least 5 years.
- Aged between 18 and 65.
- The exclusion criteria :
- A severe learning disability, an organic brain disorder , a high level of disturbed behavior, or a significant risk of suicide or homicide.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Punjab Institute of mental health
Lahore, Punjab Province, 54000
About this study
Official title: CULTURAL ADAPTATION OF GROUP CBT PSYCHOSIS MANUAL AND ESTABLISHING ITS EFFICACY IN PAKISTAN
A study aimed to culturally adapt group Cognitive Behavioral Therapy for psychosis (CBTp) for Pakistani patients with schizophrenia. Fifty inpatients from PIMH were randomly assigned to experimental (N=25) and control (N=25) groups. Both groups showed significant improvement in symptoms post-intervention (p\<0.05). This suggests that culturally adapted group CBTp is effective for schizophrenia patients in hospital settings, addressing the scarcity of CBT-trained therapists in government hospitals in Pakistan.
Read the detailed description
A clinical trial was conducted aiming to culturally adapt and pilot test a group Cognitive Behavioral Therapy for psychosis (CBTp) protocol for Pakistani patients diagnosed with schizophrenia spectrum disorder. This research was particularly significant given the prevalence of psychosis in Pakistan and the scarcity of trained therapists, especially in government hospitals.
Methodology:
Participant Selection: Purposive sampling was utilized to select participants from the Psychiatric Institute of Mental Health (PIMH) who were diagnosed with schizophrenia spectrum disorder and were inpatients receiving medication.
Sample Size: A total sample of N=50 was obtained, with participants randomly assigned to either the experimental (N=25) or control group (N=25).
Assessment Measures: Various assessment measures were employed to evaluate the efficacy of the intervention, including the Positive and Negative Syndrome Scale of Schizophrenia (PANSS), Rosenberg's Self Esteem Scale, Insight Scale, Brief COPE, Perceived Stress Scale, and The Psychotic Symptom Rating Scales (PSYRATS).
Intervention: The experimental group received manualized group CBT intervention consisting of 24 sessions over a duration of 3 months. The intervention was culturally adapted to suit the needs and context of Pakistani patients. Importantly, there were no dropouts from either group during the intervention period.
Statistical Analysis: An analysis of covariance (ANCOVA) was conducted to compare pre- and post-intervention ratings between the experimental and control groups.
- Being tested
- Cognitive behavioral therapy for psychosis
- Keywords
- Group CBT, CBT, schizophrenia
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for psychosisBehavioural
Cognitive behavioral therapy for psychosis is a group protocol design specially for psychotic patients to treat their positive and negative symptoms
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy for psychosis | Experimental | Experimental group given CBTp Receives: Behavioral: Cognitive behavioral therapy for psychosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS and self esteem scale
Different scales according to treatment protocol were used
Measured: 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start4 Oct 2021
- Primary completion3 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Punjab Institute of Mental Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nazish Habib, Punjab Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005388
- Sponsor's protocol ID
- PIMHclinicalTrials
- Status last verified
- May 2025
- First submitted
- 21 Mar 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CULTURAL ADAPTATION OF GROUP CBT PSYCHOSIS MANUAL AND ESTABLISHING ITS EFFICACY IN PAKISTAN
- ClinicalTrials.gov ID
- NCT07005388
- Acronym / sponsor ID
- PIMHclinicalTrials
- Keywords
- Group CBT, CBT, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Punjab Institute of Mental HealthOther government
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 5 Jun 2025 (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.
A study aimed to culturally adapt group Cognitive Behavioral Therapy for psychosis (CBTp) for Pakistani patients with schizophrenia. Fifty inpatients from PIMH were randomly assigned to experimental (N=25) and control (N=25) groups. Both groups showed significant improvement in symptoms post-intervention (p\<0.05). This suggests that culturally adapted group CBTp is effective for schizophrenia patients in hospital settings, addressing the scarcity of CBT-trained therapists in government hospitals in Pakistan.
Detailed description
A clinical trial was conducted aiming to culturally adapt and pilot test a group Cognitive Behavioral Therapy for psychosis (CBTp) protocol for Pakistani patients diagnosed with schizophrenia spectrum disorder. This research was particularly significant given the prevalence of psychosis in Pakistan and the scarcity of trained therapists, especially in government hospitals.
Methodology:
Participant Selection: Purposive sampling was utilized to select participants from the Psychiatric Institute of Mental Health (PIMH) who were diagnosed with schizophrenia spectrum disorder and were inpatients receiving medication.
Sample Size: A total sample of N=50 was obtained, with participants randomly assigned to either the experimental (N=25) or control group (N=25).
Assessment Measures: Various assessment measures were employed to evaluate the efficacy of the intervention, including the Positive and Negative Syndrome Scale of Schizophrenia (PANSS), Rosenberg's Self Esteem Scale, Insight Scale, Brief COPE, Perceived Stress Scale, and The Psychotic Symptom Rating Scales (PSYRATS).
Intervention: The experimental group received manualized group CBT intervention consisting of 24 sessions over a duration of 3 months. The intervention was culturally adapted to suit the needs and context of Pakistani patients. Importantly, there were no dropouts from either group during the intervention period.
Statistical Analysis: An analysis of covariance (ANCOVA) was conducted to compare pre- and post-intervention ratings between the experimental and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy for psychosis | Experimental | Behavioral: Cognitive behavioral therapy for psychosisExperimental group given CBTp |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A clinical diagnosis of schizophrenia or psychotic disorder for at least 5 years.
- Aged between 18 and 65.
- A severe learning disability, an organic brain disorder , a high level of disturbed behavior, or a significant risk of suicide or homicide.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cognitive behavioral therapy for psychosisCognitive behavioral therapy for psychosis is a group protocol design specially for psychotic patients to treat their positive and negative symptoms | Behavioural | Cognitive behavioral therapy for psychosis |
Primary outcome
PANSS and self esteem scale
Time frame: 6
Different scales according to treatment protocol were used
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy for psychosis in people with Psychotic Disorders and Psychosis, run by Punjab Institute of Mental Health 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 4 inclusion and 0 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: finished, as of the sponsor's last update on 5 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS and self esteem scale (time frame: 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2025.