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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06440031
Other study ID # 0000-0001-5034-0335f
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date September 30, 2025

Study information

Verified date May 2024
Source Nottingham Trent University
Contact Dung Jidong, PhD
Phone 07448930519
Email dung.jidong@mamnchester.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Suicide and self-harm are global disease burden that contributes significantly to years of lost life and mortality.


Description:

Self-harm and suicidal ideation represent a significant global public health concern (Knipe et al., 2022), affecting about 14.6 million people yearly (Nichols et al., 2021). Globally, over 700 000 people die by suicide annually (World Health Organization -- WHO, 2023). Suicide is the fourth leading cause of death among 15-29-year-olds, and 77% of global suicides occur in low- and middle-income countries, including Nigeria (WHO, 2023). The psychological impact of suicidal ideation includes continuing high tendencies of self-harm (Jidong et al., 2024). Despite the increasing rates of suicide and self-harm in Nigeria, this topic is understudied, with no culturally appropriate or sustainable psychological interventions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date September 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 24 Years
Eligibility Inclusion Criteria: - Patients aged 16-24 years presenting to the participating services, and emergency departments or admitted after an episode of self-harm to the participating hospitals or self-referrals. - Participants will have to be living within the catchment area of the participating practices, services and hospitals. - Not needing inpatient psychiatric treatment. Exclusion Criteria: - Severe mental illness (such as Psychotic disorder). - Conditions limiting engagement with assessment/intervention. - Temporary resident unlikely to be available for follow up.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CaMaPi
CaMaPi is a manually assisted brief psychological intervention that is based on the principles of Cognitive Behaviour Therapy (CBT). The intervention includes psycho-education and a comprehensive cognitive behavioural assessment of the suicidal ideation and self-harm attempt using virtual stories of four young people to be delivered in 8-10 sessions for over three months
Other:
TAU
Treatment as Usual (TAU) is routine care, such as diagnosis, assessment, psychotherapy, monitoring and any form of intervention (e.g., medication prescription) available at the collaborating service.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Nottingham Trent University Jos University Teaching Hospital, Teesside University, University of Manchester

Outcome

Type Measure Description Time frame Safety issue
Primary Change in acceptance and satisfaction with the intervention Primary outcome measure would be assessed using the Service Satisfaction Scale Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention
Secondary Change in suicidal ideation Secondary outcome measure would be assessed using the Beck Scale for Suicide Ideation Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention
Secondary Change in hopelessness Secondary outcome measure would be assessed using the Beck Hopelessness Scale Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention
Secondary Change in Health Status Secondary outcome measure would be assessed using the EQ-5D-5L quality of health scale Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention
Secondary Change in repetition rate's of self-harm Secondary outcome measure would be assessed using an adapted Suicide Attempt Self-Injury Interview Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention
Secondary Change in use of health services Secondary outcome measure would be assessed using Client Service Receipt Inventory Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention
Secondary Change in psychological distress Secondary outcome measure would be assessed using Kessler Psychological Distress Scale Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention
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