Mental HealthODISSEANCT07894354
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
A study testing Multicomponent anti-stigma educational intervention for primary care professionals in people with Mental Health and Stigma of Mental Illness, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
Trial summary
Most people turn first to primary care when they experience emotional distress. Mental health stigma can influence how symptoms are understood, the care people receive, and the trust between professionals and patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Stigma of Mental Illness
- What is being tested?
- Multicomponent anti-stigma educational intervention for primary care professionals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Dec 2028
- 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
- Primary care professionals or frontline staff working in one of the participating primary care centers.
- Eligible roles include family physicians, nurses, social workers, administrative/front-desk staff, and other relevant primary care professionals.
- Direct or indirect contact with patients as part of usual professional duties.
- Willing to participate in the ODISSEA educational intervention and complete the baseline and post-intervention assessments.
- Able to understand the study information and provide informed consent.
Who cannot join
- Not currently working in a participating primary care center.
- No relevant frontline, patient-facing, or patient-support role.
- Unable to understand the study information or provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ODISSEA: Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Most people turn first to primary care when they experience emotional distress. Mental health stigma can influence how symptoms are understood, the care people receive, and the trust between professionals and patients. ODISSEA is a pilot study that will co-create and test a practical training intervention designed to help primary care teams reduce mental health stigma in everyday practice. The program combines brief narratives from people with lived experience of mental health problems, guided reflection, and practical digital or audiovisual materials adapted to busy primary care settings. The intervention will be implemented in at least six primary care centers, and changes in mental health-related attitudes, practice-oriented knowledge, and perceived usefulness will be assessed. Focus groups with professionals and interviews with people with lived experience will explore perceived usefulness, needed adaptations, barriers, facilitators, and opportunities for improvement. The results will support the development of an optimized and transferable training package for potential integration into continuing professional education within the Catalan health system and scientific societies.
Read the detailed description
Introduction: Mental health stigma in primary care can undermine healthcare quality and equity by hindering communication, influencing clinical reasoning and decision-making, and reducing engagement. This pilot study addresses stigma at the point of care through a co-created, multicomponent educational intervention delivered in real-world primary care settings.
Objective: To assess the feasibility, acceptability, perceived usefulness, and preliminary changes in mental health-related attitudes, knowledge, and intended professional practice among primary care professionals.
Methodology: This multicenter, single-group pre-post pilot study will be conducted in at least six primary care centers. Participants will include family physicians, nurses, administrative/front-desk staff, social workers, and other relevant frontline professionals. The intervention will combine structured narrative contact with people with lived experience of mental health problems, guided reflection on stigma-related beliefs and practices, practical tools for communication and clinical decision-making, and brief digital or audiovisual reinforcement resources. Pre- and post-intervention assessments will evaluate mental health-related attitudes, knowledge, intention to change professional practice, acceptability, satisfaction, and perceived usefulness. A qualitative evaluation, including focus groups with participating professionals and semistructured interviews with people with lived experience, will explore perceived mechanisms of change, barriers, facilitators, and opportunities for improvement. Qualitative data will be analyzed using reflexive thematic analysis. Quantitative and qualitative findings will be integrated to refine the intervention.
Expected results: The study is expected to provide estimates of feasibility, including recruitment, attendance, engagement, intervention completion, and data completeness; information on acceptability and perceived usefulness; and preliminary estimates of pre-post changes in mental health-related attitudes, knowledge, and intended professional practice.
Impact and practical utility: The intervention is intended to support more person-centered communication, greater awareness of diagnostic overshadowing, and more equitable decision-making in primary care. The pilot is not designed to assess patient clinical outcomes or establish definitive intervention effectiveness. The study will generate an optimized and transferable training package, potentially including digital resources, a practical guide, audiovisual materials, and recommendations for future scale-up and evaluation within the Catalan health system and scientific societies.
- Conditions
- Mental Health, Stigma of Mental Illness
- Being tested
- Multicomponent anti-stigma educational intervention for primary care professionals
- Keywords
- Primary Health Care, Professional-patient Relations, Health Knowledge, Attitudes, Practice, Health Services Accessibility
- Medical subject headings
- Psychological Well-Being, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent anti-stigma educational intervention for primary care professionalsOther
The intervention combines four core components: (1) structured narrative contact with people with lived experience of mental health problems; (2) guided reflection on stigma-related beliefs, language and practices; (3) practical tools for communication, clinical reasoning and everyday interactions in primary care; and (4) brief digital or audiovisual reinforcement resources. It will be delivered in 1-3 sessions, totaling approximately 90-180 minutes, in face-to-face, online or hybrid format. Facilitators with experience in anti-stigma interventions will use standardized materials. Limited adaptation to local context and professional roles will be allowed, while preserving the core components.
| Study group | Role | What they receive |
|---|---|---|
| ODISSEA multicomponent anti-stigma intervention | Experimental | The intervention is a multicomponent anti-stigma educational program for primary care professionals, adapted through a co-creation process. Core components include structured contact with people with lived experience of mental health problems, guided reflection on stigma-related beliefs and practices, practical tools for communication and clinical decision-making, and brief digital or audiovisual reinforcement materials. The intervention will be delivered in 1-3 sessions, with an approximate total duration of 90-180 minutes, in face-to-face, online, or hybrid format. Limited contextual adaptation will be allowed while preserving the core components. Receives: Other: Multicomponent anti-stigma educational intervention for primary care professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Professional recruitment rate (Feasibility)
Proportion of eligible primary care professionals who enroll in the study among those invited to participate. The outcome will be reported as a percentage.
Measured: At completion of recruitment at each participating center, up to 6 months after recruitment initiation
Intervention completion rate (Feasibility)
Proportion of enrolled participants who complete the planned ODISSEA educational intervention. Completion will be defined as completion of the required intervention components according to the final intervention format established before implementation. The outcome will be reported as a percentage.
Measured: At completion of recruitment at each participating center, up to 6 months after recruitment initiation
Completeness of outcome data (Feasibility)
Proportion of enrolled participants with complete baseline (T0) and immediate post-intervention (T1) study assessments. The outcome will be reported as the percentage of participants with complete paired assessments.
Measured: Baseline (T0) through immediately after completion of the intervention (T1)
Acceptability and satisfaction assessed with the Client Satisfaction Questionnaire (CSQ-8)
Acceptability and satisfaction will be assessed after the intervention using the Client Satisfaction Questionnaire (CSQ-8). The instrument contains 8 items with 4 response options and yields a total score ranging from 8 to 32, with higher scores indicating greater satisfaction with the intervention.
Measured: Immediately after completion of the intervention (T1)
Secondary outcomes (3)
Change in mental health stigma-related attitudes measured with the OMS-HC-15
Stigma-related attitudes among primary care professionals will be assessed using the 15-item Opening Minds Stigma Scale for Health Care Providers (OMS-HC-15), with 5-point Likert response options. The same scale will be administered before and immediately after the intervention to estimate within-participant pre-post change.
Measured: Baseline (T0) and immediately after completion of the intervention (T1)
Change in knowledge about mental health stigma and related primary care practices
Knowledge will be assessed using a brief study-specific questionnaire with true/false/don't know items covering recovery, risk, respectful language, autonomy and rights, administrative interactions, and diagnostic overshadowing. The same questionnaire will be administered at T0 and T1. Items will be analyzed individually and, if prespecified in the statistical analysis plan, may also be summarized as an overall knowledge score.
Measured: Baseline (T0) and immediately after completion of the intervention (T1)
Change in intention to modify professional practice
Intention to change professional practice will be assessed using a study-specific 5-item questionnaire with 4-point Likert response options. Items address intended changes in communication, use of stigmatizing labels or expressions, diagnostic reasoning, patient participation in decision-making, and team processes. The same items and response scale will be administered at T0 and T1.
Measured: Baseline (T0) and immediately after completion of the intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startMar 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter, single-group pilot study with a pre-post evaluation. All participating primary care professionals will receive the same multicomponent anti-stigma educational intervention; no concurrent control group will be used. Outcomes will be assessed immediately before and after the intervention. The interventional phase is preceded by co-creation and adaptation of the intervention and followed by a qualitative process evaluation. These preparatory and qualitative components do not constitute separate intervention arms.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació La Caixa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894354
- Sponsor's protocol ID
- HC26-00263
- Acronym
- ODISSEA
- Status last verified
- Aug 2026
- First submitted
- 15 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the study includes a relatively small multicenter sample of primary care professionals and qualitative data that may contain potentially identifiable contextual information. Public release of individual-level data could therefore create a risk of re-identification, even after removal of direct identifiers. Study data will be stored in secure institutional systems with access restricted to authorized members of the research team. Results will be reported in aggregated or anonymized form in scientific publications and other dissemination outputs.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ODISSEA: Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
- ClinicalTrials.gov ID
- NCT07894354
- Acronym / sponsor ID
- ODISSEA / HC26-00263
- Conditions
- Mental Health, Stigma of Mental Illness
- Keywords
- Primary Health Care, Professional-patient Relations, Health Knowledge, Attitudes, Practice, Health Services Accessibility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Fundació La Caixa
- Study start
- Mar 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Oct 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.
Most people turn first to primary care when they experience emotional distress. Mental health stigma can influence how symptoms are understood, the care people receive, and the trust between professionals and patients. ODISSEA is a pilot study that will co-create and test a practical training intervention designed to help primary care teams reduce mental health stigma in everyday practice. The program combines brief narratives from people with lived experience of mental health problems, guided reflection, and practical digital or audiovisual materials adapted to busy primary care settings. The intervention will be implemented in at least six primary care centers, and changes in mental health-related attitudes, practice-oriented knowledge, and perceived usefulness will be assessed. Focus groups with professionals and interviews with people with lived experience will explore perceived usefulness, needed adaptations, barriers, facilitators, and opportunities for improvement. The results will support the development of an optimized and transferable training package for potential integration into continuing professional education within the Catalan health system and scientific societies.
Detailed description
Introduction: Mental health stigma in primary care can undermine healthcare quality and equity by hindering communication, influencing clinical reasoning and decision-making, and reducing engagement. This pilot study addresses stigma at the point of care through a co-created, multicomponent educational intervention delivered in real-world primary care settings.
Objective: To assess the feasibility, acceptability, perceived usefulness, and preliminary changes in mental health-related attitudes, knowledge, and intended professional practice among primary care professionals.
Methodology: This multicenter, single-group pre-post pilot study will be conducted in at least six primary care centers. Participants will include family physicians, nurses, administrative/front-desk staff, social workers, and other relevant frontline professionals. The intervention will combine structured narrative contact with people with lived experience of mental health problems, guided reflection on stigma-related beliefs and practices, practical tools for communication and clinical decision-making, and brief digital or audiovisual reinforcement resources. Pre- and post-intervention assessments will evaluate mental health-related attitudes, knowledge, intention to change professional practice, acceptability, satisfaction, and perceived usefulness. A qualitative evaluation, including focus groups with participating professionals and semistructured interviews with people with lived experience, will explore perceived mechanisms of change, barriers, facilitators, and opportunities for improvement. Qualitative data will be analyzed using reflexive thematic analysis. Quantitative and qualitative findings will be integrated to refine the intervention.
Expected results: The study is expected to provide estimates of feasibility, including recruitment, attendance, engagement, intervention completion, and data completeness; information on acceptability and perceived usefulness; and preliminary estimates of pre-post changes in mental health-related attitudes, knowledge, and intended professional practice.
Impact and practical utility: The intervention is intended to support more person-centered communication, greater awareness of diagnostic overshadowing, and more equitable decision-making in primary care. The pilot is not designed to assess patient clinical outcomes or establish definitive intervention effectiveness. The study will generate an optimized and transferable training package, potentially including digital resources, a practical guide, audiovisual materials, and recommendations for future scale-up and evaluation within the Catalan health system and scientific societies.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, single-group pilot study with a pre-post evaluation. All participating primary care professionals will receive the same multicomponent anti-stigma educational intervention; no concurrent control group will be used. Outcomes will be assessed immediately before and after the intervention. The interventional phase is preceded by co-creation and adaptation of the intervention and followed by a qualitative process evaluation. These preparatory and qualitative components do not constitute separate intervention arms.
| Arm | Type | Receives |
|---|---|---|
| ODISSEA multicomponent anti-stigma intervention | Experimental | Other: Multicomponent anti-stigma educational intervention for primary care professionalsThe intervention is a multicomponent anti-stigma educational program for primary care professionals, adapted through a co-creation process. Core components include structured contact with people with lived experience of mental health problems, guided reflection on stigma-related beliefs and practices, practical tools for communication and clinical decision-making, and brief digital or audiovisual reinforcement materials. The intervention will be delivered in 1-3 sessions, with an approximate total duration of 90-180 minutes, in face-to-face, online, or hybrid format. Limited contextual adaptation will be allowed while preserving the core components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary care professionals or frontline staff working in one of the participating primary care centers.
- Eligible roles include family physicians, nurses, social workers, administrative/front-desk staff, and other relevant primary care professionals.
- Direct or indirect contact with patients as part of usual professional duties.
- Willing to participate in the ODISSEA educational intervention and complete the baseline and post-intervention assessments.
- Able to understand the study information and provide informed consent.
Key exclusion criteria (3 listed)
- Not currently working in a participating primary care center.
- No relevant frontline, patient-facing, or patient-support role.
- Unable to understand the study information or provide informed consent.
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 |
|---|---|---|
| Multicomponent anti-stigma educational intervention for primary care professionalsThe intervention combines four core components: (1) structured narrative contact with people with lived experience of mental health problems; (2) guided reflection on stigma-related beliefs, language and practices; (3) practical tools for communication, clinical reasoning and everyday interactions in primary care; and (4) brief digital or audiovisual reinforcement resources. It will be delivered in 1-3 sessions, totaling approximately 90-180 minutes, in face-to-face, online or hybrid format. Facilitators with experience in anti-stigma interventions will use standardized materials. Limited adaptation to local context and professional roles will be allowed, while preserving the core components. | Other | ODISSEA multicomponent anti-stigma intervention |
Primary outcome
Professional recruitment rate (Feasibility)
Time frame: At completion of recruitment at each participating center, up to 6 months after recruitment initiation
Proportion of eligible primary care professionals who enroll in the study among those invited to participate. The outcome will be reported as a percentage.
Intervention completion rate (Feasibility)
Time frame: At completion of recruitment at each participating center, up to 6 months after recruitment initiation
Proportion of enrolled participants who complete the planned ODISSEA educational intervention. Completion will be defined as completion of the required intervention components according to the final intervention format established before implementation. The outcome will be reported as a percentage.
Completeness of outcome data (Feasibility)
Time frame: Baseline (T0) through immediately after completion of the intervention (T1)
Proportion of enrolled participants with complete baseline (T0) and immediate post-intervention (T1) study assessments. The outcome will be reported as the percentage of participants with complete paired assessments.
Acceptability and satisfaction assessed with the Client Satisfaction Questionnaire (CSQ-8)
Time frame: Immediately after completion of the intervention (T1)
Acceptability and satisfaction will be assessed after the intervention using the Client Satisfaction Questionnaire (CSQ-8). The instrument contains 8 items with 4 response options and yields a total score ranging from 8 to 32, with higher scores indicating greater satisfaction with the intervention.
3 secondary outcomes
Change in mental health stigma-related attitudes measured with the OMS-HC-15
Time frame: Baseline (T0) and immediately after completion of the intervention (T1)
Change in knowledge about mental health stigma and related primary care practices
Time frame: Baseline (T0) and immediately after completion of the intervention (T1)
Change in intention to modify professional practice
Time frame: Baseline (T0) and immediately after completion of the intervention (T1)
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 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the study includes a relatively small multicenter sample of primary care professionals and qualitative data that may contain potentially identifiable contextual information. Public release of individual-level data could therefore create a risk of re-identification, even after removal of direct identifiers. Study data will be stored in secure institutional systems with access restricted to authorized members of the research team. Results will be reported in aggregated or anonymized form in scientific publications and other dissemination outputs.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent anti-stigma educational intervention for primary care professionals in people with Mental Health and Stigma of Mental Illness, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
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 5 inclusion and 3 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 Oct 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 Enric Aragones, MD. PhD (+34 680 766 923, earagones.tgn.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Professional recruitment rate (Feasibility) (time frame: At completion of recruitment at each participating center, up to 6 months after recruitment initiation). 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 26 Oct 2026.