NCT07005388

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

March 21, 2024

Last Update Submit

May 27, 2025

Conditions

Psychotic DisordersPsychosisSchizophrenia and Related Disorders

Keywords

Group CBTCBTschizophrenia

Outcome Measures

Primary Outcomes (1)

  • PANSS and self esteem scale

    Different scales according to treatment protocol were used

    6

Study Arms (1)

Cognitive behavioral therapy for psychosis

EXPERIMENTAL

Experimental group given CBTp

Behavioral: Cognitive behavioral therapy for psychosis

Interventions

Cognitive behavioral therapy for psychosisBEHAVIORAL

Cognitive behavioral therapy for psychosis is a group protocol design specially for psychotic patients to treat their positive and negative symptoms

Cognitive behavioral therapy for psychosis

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A clinical diagnosis of schizophrenia or psychotic disorder for at least 5 years.
  • Aged between 18 and 65.

You may not qualify if:

  • A severe learning disability, an organic brain disorder , a high level of disturbed behavior, or a significant risk of suicide or homicide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Punjab Institute of mental health

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

March 21, 2024

First Posted

June 5, 2025

Study Start

October 4, 2021

Primary Completion

May 3, 2023

Study Completion

May 3, 2023

Last Updated

June 5, 2025

Record last verified: 2025-05

Locations

PA(1)