DepressionNCT07251478
Transparent Communication to Improve Mental Wellbeing and Attitude Towards Reintegration
A study testing Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) in people with Depression and Anxiety, run by Teesside University.
Trial summary
Reintegrating those once affiliated with proscribed terrorist groups constitutes significant global challenges due to public stigma, poor awareness of reintegration programmes and resentment towards incentives provided to rehabilitated former members of such groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Trauma
- What is being tested?
- Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years and above
- Able to provide full consent for their participation.
- A resident of the study areas
Who cannot join
- Less than 18 years
- Unable to consent
- Currently undergoing severe mental health treatment
- Unable to speak the English language fluently
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dung E Jidong, PhD contact
About this study
Official title: Transparent Communication to Improve Mental Wellbeing and Public Attitude Towards the Reintegration of Former Boko Haram Members in Nigeria: A Pilot Randomised Control Trial
Reintegrating those once affiliated with proscribed terrorist groups constitutes significant global challenges due to public stigma, poor awareness of reintegration programmes and resentment towards incentives provided to rehabilitated former members of such groups. Of central concern is the anxiety, trauma and depression suffered alongside distrust for reintegration programmes, including the genuine repentance of former members of the proscribed group. The implication is its risk in exacerbating reoffending. Yet, a gap exists to address this urgent problem. The proposed study seeks to test and pilot the feasibility and acceptability of a novel intervention called Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) in improving mental well-being and public attitude towards reintegration. The intervention is a low-intensity intervention lasting approximately 3-5 minutes design to create awareness on the rationale behind reintegration programme, reduce anxiety, depression and foster positive attitude towards reintegration.
- Conditions
- Depression, Anxiety, Trauma, Stress, Trauma, Psychological
- Being tested
- Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE)
- Keywords
- Anxiety, Depression, Reintegration, Trauma
- Medical subject headings
- Depression, Anxiety Disorders, Wounds and Injuries, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE)Behavioural
The Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) intervention is a low-intensity intervention lasting 3-5 minutes. The intervention is underpinned by awareness creation, reducing depression and anxiety and the purpose of reintegration programme to encourage change in negative attitudes towards reintegration. The recorded message introduction will commence with a welcome address on the topic, and this is followed by the core message and a closing remark. The core message is composed of three key ambits: 1) emphasizing mental health and welbeing alongside the importance of the reintegration programme, the rationale behind the reintegration programme, including the provision of incentives to dissuade reoffending, (ii) the need for empathy, prosociality, and positive social identity and advantages of reintegration and (iii) calling on the public to forgive and accept them back. The programme will end with a thank you to the audience for listening.
| Study group | Role | What they receive |
|---|---|---|
| Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) | Experimental | The Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) intervention is a low-intensity intervention lasting 3-5 minutes. Receives: Behavioral: Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) |
| Control - Waitlist Group | No intervention | The control group will not receive an intervention until after the assessment periods at baseline (day 1), and end of intervention (day 2) before they will be administered the PEACE intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Service Satisfaction Scale
A five item scale that can be used to assess and measure satisfaction, acceptability and quality of the intervention. Higher score denote positive outcomes and acceptability. Lower score denotes poor satisfaction and acceptability.
Measured: At the end of intervention (day 2)
Secondary outcomes (7)
Post-traumatic Stress Disorder Checklist (PCL-5)
The PCL-5 is a 20-item self-report measure that can be used to assess the 20 DSM-5 symptoms of post traumatic stress disorder. A 5-10 point change represents reliable change (i.e., change not due to chance) and a 10-20 point change represents clinically significant change.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Generalised Anxiety Disorder (GAD-7)
The GAD-7 is a seven item scale for screening, measuring and assessing the severity of generalised anxiety disorder. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Oslo Social Support Scale (OSSS-3)
The scale is a 3-item self-reported measure designed for assessing and measuring the level of social support. The sum score ranges from 3 to 14, with high values representing strong levels and low values representing poor levels of social support as indicated as follows: a) 3-8 poor social support, b) 9-11 moderate social support, c) 12-14 strong social support.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire that will be used for screening, monitoring, measuring and assessing the severity of depression. Low scores (e.g. 0-4) indicate no depression, however, higher scores (20-27) indicates severe depression.
Measured: Baseline (day 1) and at the end of intervention (day 2)
European Quality of Life Scale EQ-5D-5L
The EQ-5D-5L is a 5 item scale designed to aid assessment of the generic quality of life. In the EQ-5D-5L, each dimension has five response levels: no problems (Level 1); slight (Level 2); moderate (Level 3); severe (Level 4); and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).
Measured: Baseline (day 1) and at the end of intervention (day 2)
Legal-informed Awareness of Complaint Channel Scale (LACCS)
The LACCS is a 10-item scale that is designed for assessing and measuring level of awareness of complaint channels and legal rights. The scale has an overall rating of 30, with 0-7 indicating poor knowledge, 8-15 (average knowledge), 16-22 (good knowledge) and 23-30 (excellent knowledge).
Measured: Baseline (day 1) and at the end of intervention (day 2)
Attitude Towards Repentant Terrorist and their Reintegration Scale (ATRTRS)
The scale os a 26-item scale that is designed for assessing attitude towards repentant terrorist and their reintegration. The scale has a total score of 130 and assigned the following rating: 1 = Extremely poor reintegration attitude (1-26); 2 = Poor reintegration attitude (27-52); 3 = Moderate attitude towards reintegration (53-78); 4 = Good attitude towards reintegration (79-104); and 5 = Very good attitude towards reintegration (105-130).
Measured: Baseline (day 1) and at the end of intervention (day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start10 Dec 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- Jos University Teaching Hospital, University of Manchester
- Responsible party
- Principal investigator, Tarela Ike, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251478
- Sponsor's protocol ID
- 0000-0003-0516-0313g
- Status last verified
- Nov 2025
- First submitted
- 20 May 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.
Publications
Owonikoko, S. B. (2022). "Take them to government house or Aso Rock": Community receptivity to reintegration of operation safe corridor's deradicalised Ex-Boko Haram members in Northeastern Nigeria. Cogent Social Sciences, 8(1), 2015884.
Abdullahi, I., & Onabanjo, H. (2024). Reintegration of ex-combatants and peacebuilding in terrorised communities in northeastern Nigeria. International Journal of Research and Innovation in Social Science (IJRISS), 9 (7), 2283, 2307.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transparent Communication to Improve Mental Wellbeing and Public Attitude Towards the Reintegration of Former Boko Haram Members in Nigeria: A Pilot Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07251478
- Acronym / sponsor ID
- 0000-0003-0516-0313g
- Conditions
- Depression, Anxiety, Trauma, Stress, Trauma, Psychological
- Keywords
- Anxiety, Depression, Reintegration, Trauma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- Jos University Teaching Hospital, University of Manchester
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Nov 2025 (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.
Reintegrating those once affiliated with proscribed terrorist groups constitutes significant global challenges due to public stigma, poor awareness of reintegration programmes and resentment towards incentives provided to rehabilitated former members of such groups. Of central concern is the anxiety, trauma and depression suffered alongside distrust for reintegration programmes, including the genuine repentance of former members of the proscribed group. The implication is its risk in exacerbating reoffending. Yet, a gap exists to address this urgent problem. The proposed study seeks to test and pilot the feasibility and acceptability of a novel intervention called Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) in improving mental well-being and public attitude towards reintegration. The intervention is a low-intensity intervention lasting approximately 3-5 minutes design to create awareness on the rationale behind reintegration programme, reduce anxiety, depression and foster positive attitude towards reintegration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) | Experimental | Behavioral: Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE)The Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) intervention is a low-intensity intervention lasting 3-5 minutes. |
| Control - Waitlist Group | No intervention | –The control group will not receive an intervention until after the assessment periods at baseline (day 1), and end of intervention (day 2) before they will be administered the PEACE intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and above
- Able to provide full consent for their participation.
- A resident of the study areas
Key exclusion criteria (4 listed)
- Less than 18 years
- Unable to consent
- Currently undergoing severe mental health treatment
- Unable to speak the English language fluently
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 |
|---|---|---|
| Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE)The Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) intervention is a low-intensity intervention lasting 3-5 minutes. The intervention is underpinned by awareness creation, reducing depression and anxiety and the purpose of reintegration programme to encourage change in negative attitudes towards reintegration. The recorded message introduction will commence with a welcome address on the topic, and this is followed by the core message and a closing remark. The core message is composed of three key ambits: 1) emphasizing mental health and welbeing alongside the importance of the reintegration programme, the rationale behind the reintegration programme, including the provision of incentives to dissuade reoffending, (ii) the need for empathy, prosociality, and positive social identity and advantages of reintegration and (iii) calling on the public to forgive and accept them back. The programme will end with a thank you to the audience for listening. | Behavioural | Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) |
Primary outcome
Service Satisfaction Scale
Time frame: At the end of intervention (day 2)
A five item scale that can be used to assess and measure satisfaction, acceptability and quality of the intervention. Higher score denote positive outcomes and acceptability. Lower score denotes poor satisfaction and acceptability.
7 secondary outcomes
Post-traumatic Stress Disorder Checklist (PCL-5)
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Generalised Anxiety Disorder (GAD-7)
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Oslo Social Support Scale (OSSS-3)
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline (day 1) and at the end of intervention (day 2)
European Quality of Life Scale EQ-5D-5L
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Legal-informed Awareness of Complaint Channel Scale (LACCS)
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Attitude Towards Repentant Terrorist and their Reintegration Scale (ATRTRS)
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- BackgroundOwonikoko, S. B. (2022). "Take them to government house or Aso Rock": Community receptivity to reintegration of operation safe corridor's deradicalised Ex-Boko Haram members in Northeastern Nigeria. Cogent Social Sciences, 8(1), 2015884.
- BackgroundAbdullahi, I., & Onabanjo, H. (2024). Reintegration of ex-combatants and peacebuilding in terrorised communities in northeastern Nigeria. International Journal of Research and Innovation in Social Science (IJRISS), 9 (7), 2283, 2307.
- Individual participant dataSharing planned: No. Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.
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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.
Dung E Jidong, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) in people with Depression and Anxiety, 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 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: opening soon, as of the sponsor's last update on 26 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarela J Ike, PhD (0164234231, 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?
Service Satisfaction Scale (time frame: At the end of intervention (day 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07251478, which also lists 2 linked publications.
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 26 Nov 2025.