AnxietyCONSCIOUSNCT07627451
CONSCIOUS: A Pilot Trial of a Media Orientation Intervention to Encourage Men's Help Seeking for Mental Health Difficulties
A study testing Psychosocial media campaign and Intervention as usual in people with Anxiety and Mental Health, run by Teesside University.
Trial summary
Mental health difficulties among males are an issue of public health concern. Men are also at higher risk of suicidal ideation and self-harm and are poor at help-seeking due to factors including stigma, cultural norms and gendered expectations of masculinity. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Mental Health, Suicide Awareness
- What is being tested?
- Psychosocial media campaign and Intervention as usual
- 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
- 30 Jun 2026to 3 Jun 2027
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male, aged 18 years or above, able to provide full informed consent to aid their participation, able to speak the English language which is Nigeria language. able to take part in the intervention and are available for the intervention assessment at baseline and end of intervention.
Who cannot join
- less than 18 years old, unable to provide informed consent, undergoing severe mental health treatment and unable to speak the English language. Participants were also excluded if they are high risk social ideation or self-harm patients.
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: Media Orientation to Prevent Suicidal Ideation and Self Harm and Improve Help Seeking Behaviour: A Pilot Randomised Controlled Trial
Mental health difficulties among males are an issue of public health concern. Men are also at higher risk of suicidal ideation and self-harm and are poor at help-seeking due to factors including stigma, cultural norms and gendered expectations of masculinity. Yet, in Nigeria, a significant gap remains in media orientation intervention to create awareness on symptoms of mental health difficulties and support channels to encourage help-seeking. In essence, the current study aims to test the feasibility and acceptability of a novel intervention titled, psyChosOcial media awareNesS for SuiCIde symptoms, including other mental health PrOblems and help seeking mediUmS (CONSCIOUS) for addressing awareness of mental health difficulties in comparison to the waitlist control group for the purposes of improving men's help seeking, social support and reducing anxiety in Nigeria.
- Conditions
- Anxiety, Mental Health, Suicide Awareness, Awareness Training, Public Health
- Being tested
- Psychosocial media campaign, Intervention as usual
- Keywords
- Help-seeking for mental health difficulties, suicidal ideation, self harm awareness, media awareness for mental health difficulties
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being, Suicide Prevention, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial media campaignBehavioural
The CONSCIOUS is 3 minutes recorded media message. The intervention is designed to promote awareness on how to prevent suicidal ideation and self-harm, stigma reduction and avenues or mediums for help-seeking. The core message is composed of three key ambits: 1) emphasizing what is meant by suicidal ideation and self-harm (ii) the need to seek help and stop societal stigmatising behaviour (iii) Avenues for help seeking and improved mental health and wellbeing.
Intervention as usualOther
Current available interventions to foster help seeking including leaflets, community health centre provision of information etc. This group will be later offered the CONSCIOUS intervention after completion of baseline and end of intervention assessment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental : psyChosOcial media awareNesS for SuiCIde symptoms and other mental health PrOblems | Experimental | Low intensity media campaign intervention Receives: Behavioral: Psychosocial media campaign |
| Control - Intervention as Usual/Waitlist | Other | Intervention as Usual / Waitlist to be administered the CONSCIOUS intervention after assessment at baseline (day 1) and end of intervention (day 2). Receives: Other: Intervention as usual |
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: Immediately after the end of the intervention
Secondary outcomes (10)
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)
Attitude Towards Seeking Professional Psychological Help Scale
The ATSPPH is a 10-item scale that measures attitude towards seeking professional psychological help. Higher scores reflect increased positive attitude towards seeking professional psychological help while lower score reflects reduced attitude towards seeking help.
Measured: Baseline (day 1) and at the end of intervention (day 2)
General Help Seeking Questionnaire (GHSQ)
The GHSQ is a 20-item scale measuring the likelihood of seeking help from a range of sources. The scale adopts a Likert style rating as follows: Extremely unlikely(1), Somewhat unlikely (2), Unlikely (3), Not sure (4), Likely =5, Somewhat likely = 6, Extremely likely =7. The scores are summed across all help-seeking items. For a standard 9-item list, total scores range from 9 to 63 points. Higher total scores indicate a greater overall intention to seek help from someone.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Self Stigma and Help Seeking (SSHS) Scale
The self-stigma and help seeking scale is a 10-item scale that measures stigma of seeking help. The scale features 10 items, each rated on a 5-point Likert scale ranging from 1 = Strongly Disagree to 5 = Strongly. Items 2, 4, 5, 7, and 9 are reverse-scored. The possible total score ranges from 10 to 50. Higher total scores indicate higher levels of internalised self-stigma associated with seeking professional psychological help.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Stigma of Suicide Scale (SOSS)
The Stigma of Suicide Scale (SOSS) measures public attitudes and stigma toward suicide, aiding research on societal perceptions and informing anti-stigma interventions to improve mental health outcomes. The long form consists of 58 items and the short form consists of 16 items. Each item consists of a one-word descriptor of a person who dies by suicide. A person completes the scale by rating how much they agree with each item being a descriptor of someone who takes their own life. Each item is to be rated on a 5-point Likert scale from (1) strongly disagree to (5) strongly agree. Higher scores indicate higher levels of stigma towards people who suicide.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Beck Hopelessness Scale (BHS)
The Beck Hopelessness Scale (BHS) is a 20-item, true/false self-report inventory designed to measure an individual's negative attitudes or pessimism about the future. Lower score indicate none or minimal while higher score indicate severe.
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)
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-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a standard diagnostic tool used to screen for and measure the severity of depression. Scores range from 0 to 27, calculated by assigning 0 to 3 points for each of the nine questions. Scores ≤4 suggest minimal depression which may not require treatment. Higher score suggest depression.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report questionnaire used to assess PTSD symptoms based on DSM-5 criteria. It evaluates symptoms over the past month on a 0 to 4 scale, yielding a total severity score from 0 to 80. A score of 31-33 or higher is generally considered the clinical cutoff. Scores in this range suggest a provisional PTSD diagnosis.
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 posted4 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion3 Jun 2027 (estimated)
- Study completion3 Jun 2027 (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 AnxietyStudies 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
- The University of Manchester, Jos University Teaching Hospital
- Responsible party
- Principal investigator, Tarela Ike, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627451
- Sponsor's protocol ID
- 0000-0003-0516-0313h
- Other IDs
- CONSCIOUS
- Acronym
- CONSCIOUS
- Status last verified
- May 2026
- First submitted
- 30 May 2026
- Last updated
- 4 Jun 2026
- 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
Pirkis J, Rossetto A, Nicholas A, Ftanou M, Robinson J, Reavley N. Suicide Prevention Media Campaigns: A Systematic Literature Review. Health Commun. 2019 Apr;34(4):402-414. doi: 10.1080/10410236.2017.1405484. Epub 2017 Nov 30.
PubMed 29190128Ftanou M, Cox G, Nicholas A, Spittal MJ, Machlin A, Robinson J, Pirkis J. Suicide Prevention Public Service Announcements (PSAs): Examples from Around the World. Health Commun. 2017 Apr;32(4):493-501. doi: 10.1080/10410236.2016.1140269. Epub 2016 Jun 16.
PubMed 27308843
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Media Orientation to Prevent Suicidal Ideation and Self Harm and Improve Help Seeking Behaviour: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07627451
- Acronym / sponsor ID
- CONSCIOUS / 0000-0003-0516-0313h
- Conditions
- Anxiety, Mental Health, Suicide Awareness, Awareness Training, Public Health
- Keywords
- Help-seeking for mental health difficulties, suicidal ideation, self harm awareness, media awareness for mental health difficulties
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- The University of Manchester, Jos University Teaching Hospital
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 3 Jun 2027 (estimated)
- Study completion
- 3 Jun 2027 (estimated)
- First posted
- 4 Jun 2026 (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.
Mental health difficulties among males are an issue of public health concern. Men are also at higher risk of suicidal ideation and self-harm and are poor at help-seeking due to factors including stigma, cultural norms and gendered expectations of masculinity. Yet, in Nigeria, a significant gap remains in media orientation intervention to create awareness on symptoms of mental health difficulties and support channels to encourage help-seeking. In essence, the current study aims to test the feasibility and acceptability of a novel intervention titled, psyChosOcial media awareNesS for SuiCIde symptoms, including other mental health PrOblems and help seeking mediUmS (CONSCIOUS) for addressing awareness of mental health difficulties in comparison to the waitlist control group for the purposes of improving men's help seeking, social support and reducing anxiety in Nigeria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : psyChosOcial media awareNesS for SuiCIde symptoms and other mental health PrOblems | Experimental | Behavioral: Psychosocial media campaignLow intensity media campaign intervention |
| Control - Intervention as Usual/Waitlist | Other | Other: Intervention as usualIntervention as Usual / Waitlist to be administered the CONSCIOUS intervention after assessment at baseline (day 1) and end of intervention (day 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male, aged 18 years or above, able to provide full informed consent to aid their participation, able to speak the English language which is Nigeria language. able to take part in the intervention and are available for the intervention assessment at baseline and end of intervention.
Key exclusion criteria (1 listed)
- less than 18 years old, unable to provide informed consent, undergoing severe mental health treatment and unable to speak the English language. Participants were also excluded if they are high risk social ideation or self-harm patients.
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 |
|---|---|---|
| Psychosocial media campaignThe CONSCIOUS is 3 minutes recorded media message. The intervention is designed to promote awareness on how to prevent suicidal ideation and self-harm, stigma reduction and avenues or mediums for help-seeking. The core message is composed of three key ambits: 1) emphasizing what is meant by suicidal ideation and self-harm (ii) the need to seek help and stop societal stigmatising behaviour (iii) Avenues for help seeking and improved mental health and wellbeing. | Behavioural | Experimental : psyChosOcial media awareNesS for SuiCIde symptoms and other mental health PrOblems |
| Intervention as usualCurrent available interventions to foster help seeking including leaflets, community health centre provision of information etc. This group will be later offered the CONSCIOUS intervention after completion of baseline and end of intervention assessment. | Other | Control - Intervention as Usual/Waitlist |
Primary outcome
Service Satisfaction Scale
Time frame: Immediately after the end of the intervention
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.
10 secondary outcomes
Generalised Anxiety Disorder (GAD-7)
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Attitude Towards Seeking Professional Psychological Help Scale
Time frame: Baseline (day 1) and at the end of intervention (day 2)
General Help Seeking Questionnaire (GHSQ)
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Self Stigma and Help Seeking (SSHS) Scale
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Stigma of Suicide Scale (SOSS)
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Beck Hopelessness Scale (BHS)
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)
Oslo Social Support Scale (OSSS-3)
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
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 4 Jun 2026.
- Background: PubMed 29190128Pirkis J, Rossetto A, Nicholas A, Ftanou M, Robinson J, Reavley N. Suicide Prevention Media Campaigns: A Systematic Literature Review. Health Commun. 2019 Apr;34(4):402-414. doi: 10.1080/10410236.2017.1405484. Epub 2017 Nov 30.
- Background: PubMed 27308843Ftanou M, Cox G, Nicholas A, Spittal MJ, Machlin A, Robinson J, Pirkis J. Suicide Prevention Public Service Announcements (PSAs): Examples from Around the World. Health Commun. 2017 Apr;32(4):493-501. doi: 10.1080/10410236.2016.1140269. Epub 2016 Jun 16.
- Individual participant dataSharing planned: No. Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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 Psychosocial media campaign and Intervention as usual in people with Anxiety and Mental Health, 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 1 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: opening soon, as of the sponsor's last update on 4 Jun 2026. 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: Immediately after the end of the intervention). 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 NCT07627451, 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 4 Jun 2026.