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

A Randomized Controlled Trial of Culturally Adapted Cognitive Behavior Therapy Based Guided Self- Help Manual for Schizophrenia Spectrum Disorder

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia Disorders; Receives Treatment As Usual; Receives Culturally Adapted CBTp GSH
• Intervention / Treatment: Drug: Treatment as usual; Behavioral: Cognitive behavior therapy based guided self help manual for psychosis plus treatment as usual

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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Lahore, Pakistan
    • University of the Punjab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The inclusion criteria of the present research was

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Receives culturally adapted CBTp- GHS plus treatment as usual.; Participants receive culturally adapted Cognitive Behaviour Therapy for Psychosis-based Guided Self-Help.
Active Comparator: Group 2: Receives Treatment As Usual (TAU).; TAU Arm: Participants receive standard treatment as usual.	Drug: Treatment as usual; anti psychotic drugs which they are already using

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POSITIVE AND NEGATIVE SYMPTOM SCALE	Positive and negative symptom scale was administered on pre and post level to measure the severity of symptoms High score indicates the worse outcome Lower score indicates better outcome	8 TO 12 WEEKS

Collaborators and Investigators

• Sponsor: University of the Punjab

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Actual): May 5, 2024
• Study Completion (Actual): August 12, 2024

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Schizophrenia Spectrum Disorder, culturally adapted, Guided Self-Help, RCT
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: Punjab University PHD thesis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No