DepressionNCT05640921
Group-integrated Cognitive Behavioural Therapy (Gi-CBT) to Aid Communities' Reintegration of Former Terrorists in Nigeria: A Randomised Control Trial
A study testing Gi-CBT and Media Orientation in people with Depression and Trauma, run by Teesside University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Trauma, Anxiety
- What is being tested?
- Gi-CBT and Media Orientation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- those not meeting the study inclusion criteria will be excluded.
About this study
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.
Read the 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.
- Conditions
- Depression, Trauma, Anxiety, Fear
- Being tested
- Gi-CBT, Media Orientation
- Medical subject headings
- Depression, Wounds and Injuries, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gi-CBTBehavioural
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.
Media OrientationOther
The MO sessions will embed media content to create awareness of the government's approaches to reintegration.
| Study group | Role | What they receive |
|---|---|---|
| Group-integrated Cognitive Behavioural Therapy (Gi-CBT) | Experimental | 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. Receives: Behavioral: Gi-CBT |
| Media Intervention | Active comparator | 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. Receives: Other: Media Orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Service Satisfaction Scale
Change in service satisfaction is being assessed
Measured: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention]
PHQ-9
Change in Depressive Symptoms
Measured: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention]
The Attitude Towards Repentant Terrorist and their Reintegration scale
Change in attitude towards reintegration
Measured: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention]
Trauma Screening Questionnaire
Change in traumatic experience is being assessed
Measured: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start20 Dec 2022 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- Coal City University
- Responsible party
- Principal investigator, Tarela Ike, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640921
- Sponsor's protocol ID
- 0000-0003-0516-0313c
- Status last verified
- Nov 2022
- First submitted
- 28 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group-integrated Cognitive Behavioural Therapy (Gi-CBT) to Aid Communities' Reintegration of Former Terrorists in Nigeria: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05640921
- Acronym / sponsor ID
- 0000-0003-0516-0313c
- Conditions
- Depression, Trauma, Anxiety, Fear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- Coal City University
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-integrated Cognitive Behavioural Therapy (Gi-CBT) | Experimental | Behavioral: Gi-CBTThe 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. |
| Media Intervention | Active comparator | Other: Media OrientationThe second group will receive Media Orientation (MO). The MO sessions will embed media content to create awareness of the government's approaches to reintegration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- those not meeting the study inclusion criteria will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gi-CBTGi-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. | Behavioural | Group-integrated Cognitive Behavioural Therapy (Gi-CBT) |
| Media OrientationThe MO sessions will embed media content to create awareness of the government's approaches to reintegration. | Other | Media Intervention |
Primary outcome
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
PHQ-9
Time frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention]
Change in Depressive Symptoms
The Attitude Towards Repentant Terrorist 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 attitude towards reintegration
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Gi-CBT and Media Orientation in people with Depression and Trauma, run by Teesside University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Service Satisfaction Scale (time frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.