An interventional study of Multicomponent anti-stigma educational intervention for primary care professionals in Mental Health and Stigma of Mental Illness, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Health services research
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.
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.
1,049 studies on the registry are indexed under Psychological Well-Being; 509 are open to participants now.
This study's planned enrollment of 60 is below the median of 113 across 888 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 161 studies on the registry; 21 are open to participants now.
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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.
Other: Multicomponent anti-stigma educational intervention for primary care professionals
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after completion of the intervention (T1)
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T0) and immediately after completion of the intervention (T1)
Perceived applicability of the intervention to routine primary care practice
Perceived applicability of the ODISSEA intervention to routine primary care practice will be assessed immediately after the intervention using a study-specific 5-point Likert item. Higher scores will indicate greater perceived applicability.
Time frame: Immediately after completion of the intervention (T1)
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Jun 2028, 15 months later.
Of 650 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 40. This study's planned 15 months is below that.
Counting every sponsor, half of 671 studies reached it within 20 months; a quarter within 8 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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