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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05449353
Other study ID # 0000-0003-0516-0313a
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 31, 2022
Est. completion date June 30, 2023

Study information

Verified date July 2022
Source Teesside University
Contact Tarela Ike, PhD
Phone 07831163474
Email t.ike@tees.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to describe the feasibility, cultural appropriateness, and acceptability of Trauma-informed Cognitive Behaviour Therapy (TiCBT) to promote community healing and encourage the reintegration of repentant terrorists and their families to avoid reoffending.


Description:

The study will adopt a mixed-method single-arm experimental design. Approximately 24 participants will be recruited for the intervention. The Trauma-informed Cognitive Behaviour Therapy (TiCBT) is an 8-session intervention lasting approximately 1 hour each and designed to address trauma, dispel negative attitudes and encourage positive behaviour towards repentant terrorists. Measurement will be collected at baseline pre-intervention, end of intervention and three months post-intervention to determine its feasibility and effectiveness. Interviews will also be conducted post-intervention. Repeated-measures univariate analyses of variance (ANOVA) will be performed to examine differences between the pre- and post-intervention stages. Interviews will be analysed using thematic analysis.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date June 30, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - community members who are victims of Boko Haram terrorism and had previous experiences of trauma/depression, - score five and above for the culturally-adapted Trauma Screening Questionnaire (Brewinn et al., 2002) - aged 18+ years, - able to give informed consent, - speak English - are residents or from areas within Nigeria including Maiduguri, Adamawa, and Plateau environs. Exclusion Criteria: - less than 18 or above 85 years - unable to give consent - clinically diagnosed with severe PTSD/suicidal ideations or undergoing treatment - temporary or non-residents who are unlikely to be available for follow up

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Trauma-informed Cognitive Behaviour Therapy (TiCBT)
Group: Experimental (n=24 participants) will receive the TiCBT which consists of a total of 8-group integrated sessions lasting approximately 60 minutes per session every 3 days interval with 24 persons in the single group.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Tarela Ike British International Studies Association

Outcome

Type Measure Description Time frame Safety issue
Primary Trauma Screening Questionnaire Change in traumatic experience is being assessed Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
Primary Patient Health Questionnaire Change in depression is being assessed Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
Primary Attitude Towards Repentant Terrorists and their Reintegration Scale Change in of attitude towards repentant terrorists is being assessed Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
Primary brief Verona Service Satisfaction Scale Change in service satisfaction is being assessed Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
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