CONSCIOUS: A Pilot Trial of a Media Orientation Intervention to Encourage Men's Help Seeking for Mental Health Difficulties (CONSCIOUS)

May 30, 2026 updated by: Tarela Ike, Teesside University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental : psyChosOcial media awareNesS for SuiCIde symptoms and other mental health PrOblems
Low intensity media campaign intervention
Behavioral: Psychosocial media campaign
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.
Other: Control - Intervention as Usual/Waitlist
Intervention as Usual / Waitlist to be administered the CONSCIOUS intervention after assessment at baseline (day 1) and end of intervention (day 2).
Other: Intervention as usual
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Immediately after the end of the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Generalised Anxiety Disorder (GAD-7)
Time Frame: Baseline (day 1) and at the end of intervention (day 2)
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.
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)
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.
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)
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).
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
Baseline (day 1) and at the end of intervention (day 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teesside University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jos University Teaching Hospital
The University of Manchester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0000-0003-0516-0313h
  • CONSCIOUS (Other Identifier: Teesside University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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