Receives Treatment As UsualNCT06895421
Culturally Adapted Cognitive Behavior Therapy Based Guided Self-help Manual for Schizophrenia Spectrum Disorder
A study testing Cognitive behavior therapy based guided self help manual for psychosis plus treatment as usual and Treatment as usual in people with Receives Treatment As Usual and Receives Culturally Adapted CBTp GSH, run by University of the Punjab at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Receives Treatment As Usual, Receives Culturally Adapted CBTp GSH, Schizophrenia Disorders
- What is being tested?
- Cognitive behavior therapy based guided self help manual for psychosis plus treatment as usual and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Oct 2023to 12 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Cognitive behavior therapy based guided self help manual for psychosis plus treatment as usual, Treatment as usual
- Keywords
- Schizophrenia Spectrum Disorder, culturally adapted, Guided Self-Help, RCT
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapy based guided self help manual for psychosis plus treatment as usualBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 TO 12 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start16 Oct 2023
- Primary completion5 May 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Receives Treatment As UsualStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazish Naureen, University of the Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895421
- Sponsor's protocol ID
- Punjab University PHD thesis
- Status last verified
- Mar 2025
- First submitted
- 26 Aug 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Culturally Adapted Cognitive Behavior Therapy Based Guided Self- Help Manual for Schizophrenia Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06895421
- Acronym / sponsor ID
- Punjab University PHD thesis
- Conditions
- Receives Treatment As Usual, Receives Culturally Adapted CBTp GSH, Schizophrenia Disorders
- Keywords
- Schizophrenia Spectrum Disorder, culturally adapted, Guided Self-Help, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Treatment as usualTAU Arm: Participants receive standard treatment as usual. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavior therapy based guided self help manual for psychosis plus treatment as usualThe 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. | Behavioural | – |
| Treatment as usualanti psychotic drugs which they are already using | Drug | Group 2: Receives Treatment As Usual (TAU). |
Primary outcome
POSITIVE AND NEGATIVE SYMPTOM SCALE
Time frame: 8 TO 12 WEEKS
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy based guided self help manual for psychosis plus treatment as usual and Treatment as usual in people with Receives Treatment As Usual and Receives Culturally Adapted CBTp GSH, run by University of the Punjab at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POSITIVE AND NEGATIVE SYMPTOM SCALE (time frame: 8 TO 12 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.