NCT05640921

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable depression

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

December 20, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

December 7, 2022

Status Verified

November 1, 2022

Enrollment Period

12 months

First QC Date

November 28, 2022

Last Update Submit

November 28, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Service Satisfaction Scale

    Change in service satisfaction is being assessed

    Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention]

  • PHQ-9

    Change in Depressive Symptoms

    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

    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

    Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention

Study Arms (2)

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.

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.

Other: Media Orientation

Interventions

Gi-CBTBEHAVIORAL

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.

Group-integrated Cognitive Behavioural Therapy (Gi-CBT)

The MO sessions will embed media content to create awareness of the government's approaches to reintegration.

Media Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionWounds and InjuriesAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 7, 2022

Study Start

December 20, 2022

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

December 7, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share