- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05449353
Trauma-informed Cognitive Behavioural Therapy (TiCBT) to Aid Reintegration of Repentant Terrorists and Their Families in Nigeria: A Pilot Study
July 4, 2022 updated by: Tarela Ike
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tarela Ike, PhD
- Phone Number: 44 07831163474
- Email: t.ike@tees.ac.uk
Study Contact Backup
- Name: Dung Jidong, PhD
- Phone Number: 44 07831163474
- Email: dung.jidong@ntu.ca.uk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Trauma-infomed Cognitive Behavioural Therapy
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trauma Screening Questionnaire
Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
|
Change in traumatic experience is being assessed
|
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
|
|
Patient Health Questionnaire
Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
|
Change in depression is being assessed
|
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
|
|
Attitude Towards Repentant Terrorists and their Reintegration Scale
Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
|
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
|
|
brief Verona Service Satisfaction Scale
Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
|
Change in service satisfaction is being assessed
|
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 31, 2022
Primary Completion (ANTICIPATED)
May 30, 2023
Study Completion (ANTICIPATED)
June 30, 2023
Study Registration Dates
First Submitted
July 4, 2022
First Submitted That Met QC Criteria
July 4, 2022
First Posted (ACTUAL)
July 8, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 8, 2022
Last Update Submitted That Met QC Criteria
July 4, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000-0003-0516-0313a
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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