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Group-integrated Cognitive Behavioural Therapy (Gi-CBT) to Aid Communities' Reintegration of Former Terrorists in Nigeria: A Randomised Control Trial

Primary Purpose

Depression, Trauma, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gi-CBT
Media Orientation
Sponsored by
Teesside University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: community members who had previous experience of trauma as a result of Boko Haram atrocities, score 5 and above for the culturally-adapted Trauma Screening Questionnaire (Brewinn et al., 2002) are aged 18+ years and above are residents of the designated areas including Bornu (Maiduguri), and its environs. Exclusion Criteria: those not meeting the study inclusion criteria will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group-integrated Cognitive Behavioural Therapy (Gi-CBT)

    Media Intervention

    Arm Description

    The Gi-CBT sessions will cover relevant aspects of tackling trauma, and the CBT component will involve addressing negative thoughts, building more positive ones and building resilience through post-traumatic situations and adversities.

    The second group will receive Media Orientation (MO). The MO sessions will embed media content to create awareness of the government's approaches to reintegration.

    Outcomes

    Primary Outcome Measures

    Service Satisfaction Scale
    Change in service satisfaction is being assessed
    PHQ-9
    Change in Depressive Symptoms
    The Attitude Towards Repentant Terrorist and their Reintegration scale
    Change in attitude towards reintegration
    Trauma Screening Questionnaire
    Change in traumatic experience is being assessed

    Secondary Outcome Measures

    Full Information

    First Posted
    November 28, 2022
    Last Updated
    November 28, 2022
    Sponsor
    Teesside University
    Collaborators
    Coal City University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05640921
    Brief Title
    Group-integrated Cognitive Behavioural Therapy (Gi-CBT) to Aid Communities' Reintegration of Former Terrorists in Nigeria: A Randomised Control Trial
    Official Title
    Group-integrated Cognitive Behavioural Therapy (Gi-CBT) to Aid Communities' Reintegration of Former Terrorists in Nigeria: A Randomised Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 20, 2022 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    November 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Teesside University
    Collaborators
    Coal City University

    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 project aims to make significant contributions that change the conversation in communities and policy circles through promoting knowledge of nonviolent peace strategies using the Group integrated Cognitive Behavioural Therapy (Gi-CBT) to help heal trauma, improve peace, and encourage positive rehabilitation and reintegration of former Boko Haram terrorists' members and their families.
    Detailed Description
    The main question it aims to answer are: • What is the feasibility in terms of recruitment, retention, adherence to the intervention and communities/victims' satisfaction with Gi-CBT to promote healing and improve the successful reintegration of of former Boko Haram terrorists' members and their families.into society? Participants will be randomly allocated into two groups. The first group, the intervention group, will receive the Group integrated Cognitive Behavioural Therapy (Gi-CBT). The second group will receive government intervention involving media messages from the National Orientation Agency devoid of GiCBT. Researchers will compare Gi-CBT group with the media orientation group to see if there are differences between a change in attitude towards ex-offenders' reintegration at base line, end of intervention and three months follow up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Trauma, Anxiety, Fear

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group-integrated Cognitive Behavioural Therapy (Gi-CBT)
    Arm Type
    Experimental
    Arm Description
    The Gi-CBT sessions will cover relevant aspects of tackling trauma, and the CBT component will involve addressing negative thoughts, building more positive ones and building resilience through post-traumatic situations and adversities.
    Arm Title
    Media Intervention
    Arm Type
    Active Comparator
    Arm Description
    The second group will receive Media Orientation (MO). The MO sessions will embed media content to create awareness of the government's approaches to reintegration.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Gi-CBT
    Intervention Description
    Gi-CBT designed to cover relevant aspects of tackling trauma, and the CBT component will involve addressing negative thoughts, building more positive ones and building resilience.
    Intervention Type
    Other
    Intervention Name(s)
    Media Orientation
    Intervention Description
    The MO sessions will embed media content to create awareness of the government's approaches to reintegration.
    Primary Outcome Measure Information:
    Title
    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]
    Title
    PHQ-9
    Description
    Change in Depressive Symptoms
    Time Frame
    Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention]
    Title
    The Attitude Towards Repentant Terrorist and their Reintegration scale
    Description
    Change in attitude towards reintegration
    Time Frame
    Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention]
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: community members who had previous experience of trauma as a result of Boko Haram atrocities, score 5 and above for the culturally-adapted Trauma Screening Questionnaire (Brewinn et al., 2002) are aged 18+ years and above are residents of the designated areas including Bornu (Maiduguri), and its environs. Exclusion Criteria: those not meeting the study inclusion criteria will be excluded.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Group-integrated Cognitive Behavioural Therapy (Gi-CBT) to Aid Communities' Reintegration of Former Terrorists in Nigeria: A Randomised Control Trial

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