TraumaNCT05449353
Trauma-informed Cognitive Behavioural Therapy (TiCBT) to Aid Reintegration of Repentant Terrorists and Their Families in Nigeria: A Pilot Study
A study testing Trauma-informed Cognitive Behaviour Therapy (TiCBT) in people with Trauma and Psychological, run by Tarela Ike.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Psychological
- What is being tested?
- Trauma-informed Cognitive Behaviour Therapy (TiCBT)
- 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
- 31 Jul 2022to 30 Jun 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Trauma, Psychological
- Being tested
- Trauma-informed Cognitive Behaviour Therapy (TiCBT)
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-informed Cognitive Behaviour Therapy (TiCBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Trauma-infomed Cognitive Behavioural Therapy | Experimental | 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. Receives: Behavioral: Trauma-informed Cognitive Behaviour Therapy (TiCBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Patient Health Questionnaire
Change in depression is being assessed
Measured: 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
Change in of attitude towards repentant terrorists is being assessed
Measured: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
brief Verona 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start31 Jul 2022 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarela Ike
- Sponsor type
- University, hospital or other
- Collaborators
- British International Studies Association
- Responsible party
- Sponsor-investigator, Tarela Ike, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449353
- Sponsor's protocol ID
- 0000-0003-0516-0313a
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 8 Jul 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 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-informed Cognitive Behavioural Therapy (TiCBT) to Aid Reintegration of Repentant Terrorists and Their Families in Nigeria: A Pilot Study
- ClinicalTrials.gov ID
- NCT05449353
- Acronym / sponsor ID
- 0000-0003-0516-0313a
- Conditions
- Trauma, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tarela IkeUniversity, hospital or other
- Collaborators
- British International Studies Association
- Study start
- 31 Jul 2022 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma-infomed Cognitive Behavioural Therapy | Experimental | Behavioral: Trauma-informed Cognitive Behaviour Therapy (TiCBT)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| 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. | Behavioural | Trauma-infomed Cognitive Behavioural Therapy |
Primary outcome
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 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.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-informed Cognitive Behaviour Therapy (TiCBT) in people with Trauma and Psychological, run by Tarela Ike.
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 6 inclusion and 4 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 8 Jul 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?
Contact Tarela Ike, PhD (07831163474 ext. 44, t.ike@tees.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trauma Screening Questionnaire (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 8 Jul 2022.