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
1 other identifier
interventional
170
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2024
CompletedFirst Submitted
Initial submission to the registry
August 26, 2024
CompletedFirst Posted
Study publicly available on registry
March 26, 2025
CompletedMarch 26, 2025
March 1, 2025
7 months
August 26, 2024
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Group 1: Receives culturally adapted CBTp- GHS plus treatment as usual.
EXPERIMENTALParticipants receive culturally adapted Cognitive Behaviour Therapy for Psychosis-based Guided Self-Help.
Group 2: Receives Treatment As Usual (TAU).
ACTIVE COMPARATORTAU Arm: Participants receive standard treatment as usual.
Interventions
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.
anti psychotic drugs which they are already using
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of the Punjab
Lahore, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Psychologist Punjab Institute of Mental Health, Lahore, Pakistan
Study Record Dates
First Submitted
August 26, 2024
First Posted
March 26, 2025
Study Start
October 16, 2023
Primary Completion
May 5, 2024
Study Completion
August 12, 2024
Last Updated
March 26, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share