NCT07445802

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,640

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Sep 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

January 28, 2026

Last Update Submit

February 25, 2026

Conditions

Treatment Adherence and ComplianceSevere Mental DisordersBipolar Disorder (BD)Schizophrenia Disorder

Keywords

treatment adherenceschizophreniabipolar disorderelectronic health recordsmedication

Outcome Measures

Primary Outcomes (2)

  • Medication adherence measured by the Morisky Medication Adherence Scale (MMAS-7)

    Score on the 7-item Morisky Medication Adherence Scale (MMAS-7), range 0-7, with lower scores indicating poorer adherence.

    Baseline (assessment of adherence over the previous 6 months prior to enrollment)

  • Antipsychotic medication exposure measured by Medication Use Profile (MUP)

    Percentage of days covered (%) by antipsychotic medication over the 6 months prior to enrollment, calculated using dispensing data from the Single Prescription Module (MUP).

    Baseline (medication exposure during the 6 months prior to enrollment)

Secondary Outcomes (5)

  • Validation of digital self-reported adherence against MUP dispensing data

    Baseline (comparison of self-reported adherence and dispensing data for the 6 months prior to enrollment)

  • Correlation between sociodemographic variables and medication adherence (MMAS-7 score)

    baseline

  • Correlation between sociodemographic variables and medication exposure (MUP %)

    Baseline (6 months prior to enrollment)

  • Change in medication adherence after intervention (MMAS-7 score)

    Baseline and 6 months post-intervention

  • Change in percentage of days covered after intervention (MUP data)

    Baseline and 6 months after intervention

Study Arms (1)

Patients with adherence problems in antipsychotic treatment

EXPERIMENTAL

Pre-post comparison of participants identified with reduced antipsychotic medication adherence via electronic dispensing records and self-report measures will receive a structured psychoeducational adherence-support program. The intervention consists of ten online group telehealth sessions led by clinical psychologists, including two sessions with trained peer-support contributors who have lived experience of stable recovery. Sessions focus on education about illness and medication, strategies to improve adherence, problem-solving skills, digital medication management tools, and relapse-prevention planning. Participants also receive written psychoeducational materials. Duration: approximately 10 weeks, one session per week.

Behavioral: Telehealth Psychoeducational Adherence Program

Interventions

Telehealth Psychoeducational Adherence ProgramBEHAVIORAL

Participants with reduced antipsychotic treatment adherence will receive a structured telehealth psychoeducational program designed to improve medication adherence. The program includes 10 weekly online group sessions led by clinical psychologists and two peer-support sessions, focusing on illness and medication education, adherence strategies, problem-solving, digital medication-management tools, and relapse-prevention skills. Participants also receive supportive written materials.

Also known as: ADHERA
Patients with adherence problems in antipsychotic treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Aged under 18 years old.
  • Unable to provide consent for medical or legal reasons.
  • Not registered on the Patient Portal.
  • No active prescription for antipsychotic drugs in the MUP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Kelly JF, Hoffman L, Vilsaint C, Weiss R, Nierenberg A, Hoeppner B. Peer support for mood disorder: Characteristics and benefits from attending the Depression and Bipolar Support Alliance mutual-help organization. J Affect Disord. 2019 Aug 1;255:127-135. doi: 10.1016/j.jad.2019.05.039. Epub 2019 May 23.

    PMID: 31150942RESULT

  • Orsi JA, Malinowski FRL, Kagan S, Weingarten R, Villares CC, Bressan RA, de Oliveira WF, Andrade MCR, Gadelha A. Evaluation of Ongoing Participation of People with Schizophrenia in a Mutual Support Group as a Complementary Intervention to Outpatient Psychiatric Treatment. Psychiatr Q. 2021 Sep;92(3):1283-1296. doi: 10.1007/s11126-021-09893-z. Epub 2021 Mar 24.

    PMID: 33761085RESULT

  • Chakrabarti S. Treatment-adherence in bipolar disorder: A patient-centred approach. World J Psychiatry. 2016 Dec 22;6(4):399-409. doi: 10.5498/wjp.v6.i4.399. eCollection 2016 Dec 22.

    PMID: 28078204RESULT

  • Kim J, Ozzoude M, Nakajima S, Shah P, Caravaggio F, Iwata Y, De Luca V, Graff-Guerrero A, Gerretsen P. Insight and medication adherence in schizophrenia: An analysis of the CATIE trial. Neuropharmacology. 2020 May 15;168:107634. doi: 10.1016/j.neuropharm.2019.05.011. Epub 2019 May 9.

    PMID: 31077729RESULT

  • Loots E, Goossens E, Vanwesemael T, Morrens M, Van Rompaey B, Dilles T. Interventions to Improve Medication Adherence in Patients with Schizophrenia or Bipolar Disorders: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Sep 28;18(19):10213. doi: 10.3390/ijerph181910213.

    PMID: 34639510RESULT

  • Gibson S, Brand SL, Burt S, Boden ZV, Benson O. Understanding treatment non-adherence in schizophrenia and bipolar disorder: a survey of what service users do and why. BMC Psychiatry. 2013 May 29;13:153. doi: 10.1186/1471-244X-13-153.

    PMID: 23714262RESULT

MeSH Terms

Conditions

Treatment Adherence and ComplianceMental DisordersBipolar DisorderSchizophrenia

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorBipolar and Related DisordersMood DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2026

First Posted

March 3, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share