NCT07445802Not yet recruiting
Medication Adherence in Severe Mental Illness: a Promotion Program
Therapeutic Adherence Promotion Program for Severe Mental Illness: the ADHERA Study Protocol
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
People living with serious mental illnesses such as schizophrenia and bipolar disorder often need long-term medication to stay well. However, many patients have difficulty taking medication regularly, which can increase the risk of relapse, hospitalization, and poorer quality of life. Traditionally, treatment adherence has been measured using self-report questionnaires, which may be influenced by memory or social desirability bias. With the recent expansion of electronic prescription systems in Spain, it is now possible to objectively verify whether patients collect their medications from the pharmacy. This provides a new opportunity to better understand and support treatment adherence. The ADHERA study will evaluate how well digital self-report questionnaires reflect real medication use compared with electronic dispensing records. We will also explore patient characteristics that may be associated with difficulties in medication adherence. Finally, we will test a new online psychoeducational program-including sessions led by mental health professionals and supported by peer-experience contributors-to determine whether it can help improve adherence. Participants with schizophrenia or bipolar disorder who are registered in the hospital's digital patient portal and have active antipsychotic prescriptions will be invited to complete brief adherence questionnaires online. Individuals with signs of reduced adherence will then be invited to take part in a telehealth intervention consisting of ten group sessions, where they will receive information, support, and practical strategies to maintain their treatment plan. Medication adherence will be reassessed after six months. If successful, this study may help improve how treatment adherence is measured in clinical practice, guide targeted interventions for individuals at higher risk of non-adherence, and provide evidence for scalable telehealth programs that can be easily implemented in other regions and medical conditions
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1640 (estimated)
- First submitted
- 28 Jan 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Diseases
- Schizophrenia, Bipolar disorder
- NCT number
- NCT07445802
What you commit to
- Study type: Interventional
- Planned participants: 1640
- From 1 Sept 2026 to the primary completion date, 30 Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No active prescription for antipsychotic drugs in the MUP.
Age
- Aged under 18 years old.
Other
- Unable to provide consent for medical or legal reasons.
- Not registered on the Patient Portal.
Who the study is looking for
- Diagnosis established using ICD-11 clinical criteria \[15\].
- Aged 18 years or older.
- Registered on the Patient Portal.
- With an active prescription for antipsychotic drugs in the MUP (Medication Use Profile).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.