Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607764251773 Date of Registration: 31/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Culturally adapted group-based Cognitive Behaviour Therapy for Persons with Psychosis (Group-CaCBTp) in Nigeria: A randomised controlled feasibility trial
Official scientific title Culturally adapted group-based Cognitive Behaviour Therapy for Persons with Psychosis (Group-CaCBTp) in Nigeria: A randomised controlled feasibility trial
Brief summary describing the background and objectives of the trial Psychosis is a serious mental health condition that affects how people think, feel and perceive reality. Evidence from the Nigerian Survey of Mental Health and Wellbeing suggests that approximately 2.1% of adults experience non-affective psychosis during their lifetime, with many people facing significant disability, stigma and limited access to appropriate treatment. International evidence shows that Cognitive Behaviour Therapy for psychosis (CBTp) can reduce psychotic symptoms, improve coping and enhance recovery when used alongside standard care. However, culturally adapted psychological interventions for psychosis remain scarce in Nigeria. This randomised controlled feasibility trial will evaluate the acceptability, feasibility and preliminary effectiveness of a culturally adapted group-based CBTp (Group-CaCBTp) for people with psychosis in Nigeria. The intervention incorporates culturally relevant beliefs, values and lived experiences to enhance engagement and therapeutic outcomes. Participants will be randomly assigned to receive either Group-CaCBTp plus treatment as usual or treatment as usual alone. Findings will inform the development of a larger definitive trial and support the delivery of culturally appropriate psychological care in Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Group CaCBTp
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 31/08/2026
Actual trial start date
Anticipated date of last follow up 31/12/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group CaCBTp 90 minutes Session structure (16 sessions over 16 weeks). These include (a) set‑up and engagement (S1–S3): collaborative goals, normalisation, shared formulation, crisis/safety planning, involving carers (with consent). (b) Formulation‑driven intervention (S4–S12): symptom monitoring; coping skills; behavioural experiments; graded exposure to feared situations; sleep/activation; relapse‑signature mapping; family sessions as needed, including agenda, homework, and feedback for each session. (c) Consolidation (S13–S16): relapse prevention plan, values‑based goals, transfer of skills, stepped‑down follow‑up options 34
Control Group Treatment As Usual Not applicable Treatment As Usual (TAU): TAU consists of the service providers' routine treatment, which may include a combination of antipsychotic medication, other forms of therapy and management. 34 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Persons diagnosed with psychosis (e.g., schizophrenia, schizoaffective disorder or delusional disorders using Diagnostic Criteria for Research (DCR-10). - 18-65 years, engaged with the health services for the preceding six months. - have the mental capacity to give informed consent. - resident of the trial catchment area. - willing to participate in the group-CaCBTp intervention. - fill out surveys and participate in recorded interviews. - have the ability to speak and understand English. - Severe cognitive impairment. - active suicidality. - presence of any chronic comorbid psychiatric disorders according to the DCR-10 criteria that can affect participation, such as being actively psychotic. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/07/2026 Jos University Teaching Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Lamingo, P.M.B. 2076, JUTH Jos 2076 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assess the feasibility, acceptability, and cultural appropriateness of the group-based CaCBTp intervention. These will be assessed using recruitment rate, randomisation process, session attendance data, and trial retention. End of intervention at 16 weeks
Secondary Outcome Preliminary clinical outcomes include changes in (a) Positive and Negative Syndrome Scale (PANSS), (b) The Schizophrenia Change Rating Scale (SCRS), (c) Generalised Anxiety Disorder (GAD-7), (d) Patient Health Questionnaire (PHQ-9), and (e) Quality of Life (EQ-5D) Baseline, end of intervention at 16 weeks and three months post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jos University Teaching Hospital Nigeria Lamingo, P.M.B. 2076 Jos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Centre in Africa for Living and Learning 19 King Faisal Street, Area 11 Garki, FCT Abuja 900103 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre in Africa for Living and Learning 19 King Faisal Street, Area 11 Garki, FCT Abuja Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Jos University Teaching Hospital Lamingo Jos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dung Jidong dung.jidong@call-africa.org +2348137659982 19 King Faisal Street, Area 11 Garki, FCT
City Postal code Country Position/Affiliation
Abuja Nigeria Centre in Africa for Living and Learning
Role Name Email Phone Street address
Public Enquiries Juliet Clark info@call-africa.org +2348137659982 19 King Faisal Street, Area 11 Garki, FCT
City Postal code Country Position/Affiliation
Abuja Nigeria CALL
Role Name Email Phone Street address
Scientific Enquiries Haruna Karick haruna.karick@call-africa.org +2348137859982 19 King Faisal Street, Area 11 Garki, FCT
City Postal code Country Position/Affiliation
Abuja Nigeria CALL
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes - Demographic information (gender, age, etc.) - Preliminary clinical outcomes include changes in (a) Positive and Negative Syndrome Scale (PANSS), (b) The Schizophrenia Change Rating Scale (SCRS), (c) Generalised Anxiety Disorder (GAD-7), (d) Patient Health Questionnaire (PHQ-9), and (e) Quality of Life (EQ-5D) Study Protocol Data will be shared at the three timepoints of baseline, end of interveniton at 16 weeks and three months post-enrolment follow-up for the purposes of analysis. Participant information sheet and consent forms explicitly address data sharing and transfers within the two partner organisations (Centre in Africa for Living and Learning and the Jos University Teaching Hospital), in accordance with Nigerian regulations' expectations. Only anonymised data can be access by other members of the research team.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 26/07/2026 Needed to include age 65 years as part of the the maximum age requirement Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s) Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 26/07/2026 Following instructions from the reviewer to only indicate that ethics application has been submitted and is under review. However, there seems to be no option to delete the attached consent form. I hope this can be kept dormant. FALSE, Jos University Teaching Hospital Research Ethics Committee, Lamingo, P.M.B. 2076, Jos, 2076, Nigeria, 15 Jul 2026, , +2349030001194, info@juth.org.ng, 43707_40031_4737.pdf FALSE, Jos University Teaching Hospital Research Ethics Committee , Lamingo, P.M.B. 2076, JUTH, Jos, 2076, Nigeria, 15 Jul 2026, , +2349030001194, info@juth.org.ng, 43707_40031_4737.pdf