Trauma-informed Cognitive Behavioural Therapy (TiCBT) to Aid Reintegration of Repentant Terrorists and Their Families in Nigeria: A Pilot Study
Primary Purpose
Trauma, Psychological
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Trauma-informed Cognitive Behaviour Therapy (TiCBT)
Sponsored by
About this trial
This is an interventional treatment trial for Trauma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Trauma-infomed Cognitive Behavioural Therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Trauma Screening Questionnaire
Change in traumatic experience is being assessed
Patient Health Questionnaire
Change in depression is being assessed
Attitude Towards Repentant Terrorists and their Reintegration Scale
Change in of attitude towards repentant terrorists is being assessed
brief Verona Service Satisfaction Scale
Change in service satisfaction is being assessed
Secondary Outcome Measures
Full Information
NCT ID
NCT05449353
First Posted
July 4, 2022
Last Updated
July 4, 2022
Sponsor
Tarela Ike
Collaborators
British International Studies Association
1. Study Identification
Unique Protocol Identification Number
NCT05449353
Brief Title
Trauma-informed Cognitive Behavioural Therapy (TiCBT) to Aid Reintegration of Repentant Terrorists and Their Families in Nigeria: A Pilot Study
Official Title
Trauma-informed Cognitive Behavioural Therapy (TiCBT) to Aid Reintegration of Repentant Terrorists and Their Families in Nigeria: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 31, 2022 (Anticipated)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tarela Ike
Collaborators
British International Studies Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Psychological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trauma-infomed Cognitive Behavioural Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Trauma-informed Cognitive Behaviour Therapy (TiCBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Trauma Screening Questionnaire
Description
Change in traumatic experience is being assessed
Time Frame
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
Title
Patient Health Questionnaire
Description
Change in depression is being assessed
Time Frame
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
Title
Attitude Towards Repentant Terrorists and their Reintegration Scale
Description
Change in of attitude towards repentant terrorists is being assessed
Time Frame
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
Title
brief Verona Service Satisfaction Scale
Description
Change in service satisfaction is being assessed
Time Frame
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarela Ike, PhD
Phone
07831163474
Ext
44
Email
t.ike@tees.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Dung Jidong, PhD
Phone
07831163474
Ext
44
Email
dung.jidong@ntu.ca.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trauma-informed Cognitive Behavioural Therapy (TiCBT) to Aid Reintegration of Repentant Terrorists and Their Families in Nigeria: A Pilot Study
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