Culturally Adapted Cognitive Behavior Therapy Based Guided Self-help Manual for Schizophrenia Spectrum Disorder

NCT ID: NCT06895421

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-08-12

Brief Summary

The study evaluated the effectiveness of a culturally adapted Cognitive Behaviour Therapy for Psychosis (CBTp) Guided Self-Help (CBTp-GSH) intervention. It involved three phases: a qualitative study for cultural adaptation, a Randomized Controlled Trial (RCT) to test its efficacy against standard treatment, and an assessment of clinician training in applying the intervention. The findings showed that the culturally adapted CBTp-GSH was effective for individuals with Schizophrenia Spectrum Disorder, emphasizing the need for culturally sensitive therapy materials and proper clinician training.

Detailed Description

Cognitive Behaviour Therapy for Psychosis (CBTp) is an evidence-based, widely practiced therapy in the Western world. However, it has been underutilized in low and middle-income countries due to the lack of trained therapists and the inadequate cultural adaptation of therapy materials. The study aimed to evaluate the effectiveness of a culturally adapted CBTp-based Guided Self-Help (CBTp-GSH) intervention.

Study I was a qualitative investigation into the cultural adaptation of the CBTp-based Guided Self-Help Manual for individuals with Schizophrenia Spectrum Disorder. The study comprised three phases, which included focus groups, in-depth semi-structured interviews, and panel discussions. Data were analyzed using Thematic Analysis.

Study II involved a Randomized Controlled Trial (RCT) to test the efficacy of the CBTp-GSH Manual for Schizophrenia Spectrum Disorder. A total of 140 patients were equally randomized into two groups: CBTp-GSH or Treatment As Usual (TAU). Assessments were conducted at pre-treatment, post-treatment, and three months post-treatment by blind assessors. The outcome measures included the PANSS, PSYRATS, Insight Scale, and WHO Disability Scale. The results were analyzed using intent-to-treat analysis, incorporating both descriptive and inferential statistics.

Study III focused on the use of Fidelity Assessments to train frontline clinicians in the delivery of the culturally adapted CBTp-based Guided Self-Help Manual. Frontline clinicians were trained and monitored on the application of this intervention in practice cases. The PANSS was utilized to assess psychopathology in clients, and the Revised-Cognitive Therapy for Psychosis Adherence Scale measured therapist fidelity.

The study successfully demonstrated the effectiveness of culturally adapted CBTp-GSH for Schizophrenia Spectrum Disorder and highlighted the importance of training clinicians in delivering culturally sensitive interventions.

Conditions

Receives Treatment As Usual; Receives Culturally Adapted CBTp GSH; Schizophrenia Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1: Receives culturally adapted CBTp- GHS plus treatment as usual.

Participants receive culturally adapted Cognitive Behaviour Therapy for Psychosis-based Guided Self-Help.

Group Type: EXPERIMENTAL

No interventions assigned to this group

Group 2: Receives Treatment As Usual (TAU).

TAU Arm: Participants receive standard treatment as usual.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: DRUG

anti psychotic drugs which they are already using

Interventions

Cognitive behavior therapy based guided self help manual for psychosis plus treatment as usual

The Cognitive Behavior Therapy-Based Guided Self-Help (CBTp-GSH) manual is a structured intervention designed specifically for individuals with psychosis, particularly those diagnosed with Schizophrenia Spectrum Disorders. This manual offers a culturally adapted approach, providing participants with tools and strategies rooted in Cognitive Behavioral Therapy (CBT) principles, tailored to be delivered through guided self-help.

Intervention Type: BEHAVIORAL

Treatment as usual

anti psychotic drugs which they are already using

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clients who could read and write had a minimum of 8th grade education.
• Clients who were able to engage with a mental health professional.
• Both inpatients and outpatients with a diagnosis of Schizophrenia or any Schizophrenia Spectrum Disorder, according to the DSM-V(American Psychiatric Association 2000), was included in the study.
• Client aged 18 to 60 years was included in the research.

Exclusion Criteria

• Clients with co-morbid conditions such as alcohol or substance dependence, organic
• Brain syndrome, learning disability or high levels of disturbed behavior were excluded from the research. Client with high risk of suicide or homicide based on clinical impression was excluded from the research.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of the Punjab

OTHER

Sponsor Role: lead

Responsible Party

Nazish Naureen

Clinical Psychologist Punjab Institute of Mental Health, Lahore, Pakistan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of the Punjab

Lahore, , Pakistan

Countries

Pakistan

Other Identifiers

Punjab University PHD thesis

Identifier Type: -

Identifier Source: org_study_id