NCT06895421

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

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

August 26, 2024

Last Update Submit

March 25, 2025

Conditions

Keywords

Schizophrenia Spectrum Disorder, culturally adapted, Guided Self-Help, RCT

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.

EXPERIMENTAL

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

Group 2: Receives Treatment As Usual (TAU).

ACTIVE COMPARATOR

TAU Arm: Participants receive standard treatment as usual.

Drug: 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

Group 2: Receives Treatment As Usual (TAU).

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

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

Locations