An interventional study of HERDA Pharmacist-Led Culturally Adapted Intervention in Depression, sponsored by Gadjah Mada University. Active, not recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Gadjah Mada University · Not applicable, Interventional, and Treatment
HERDA (Holistic, Evidence-based, and cultuRally adapted Depression Adherence) is a pharmacist-led intervention developed to support medication adherence among outpatients with depression in South Kalimantan, Indonesia. It combines structured counseling, behavior change strategies, pharmaceutical care, and culturally adapted educational materials to help patients identify and address difficulties in taking their prescribed medication.
The intervention incorporates the 5A Brief Counseling framework and the Transtheoretical Model (TTM), which guides counseling according to each participant's readiness to change. It also includes screening and a predefined safety pathway for suicide-related concerns, culturally adapted psychoeducation, and family or caregiver engagement when appropriate and with the participant's consent. Cultural, spiritual, and existential considerations are addressed according to individual preferences and within predefined intervention guidelines.
HERDA is delivered by trained pharmacists alongside standard psychiatric care. Participants assigned to the intervention group receive seven planned contacts over approximately four months, combining face-to-face sessions and telephone contacts. Participants assigned to the control group receive standard psychiatric care according to the study protocol.
This randomized controlled trial evaluates whether adding HERDA to standard psychiatric care improves medication adherence among outpatients with depression. The findings are intended to inform the development of evidence-based, culturally responsive pharmacist-led care for people receiving treatment for depression.
HERDA (Holistic, Evidence-based, and cultuRally adapted Depression Adherence) is a pharmacist-led, complex intervention developed to address medication non-adherence among outpatients with depression in South Kalimantan, Indonesia.
The intervention is delivered by trained pharmacists who complete competency assessment before providing HERDA. Counseling is tailored to each participant's current TTM stage. Each intervention contact follows a structured sequence comprising assessment, identification or reassessment of the TTM stage, Brief Counseling 5A, stage-matched education, appropriate use of intervention materials, collaborative action planning, family or caregiver involvement when appropriate and with participant consent, and follow-up or reassessment.
Educational content may be repeated or adjusted according to participants' needs and changes in their stage of behavioral change. Such tailoring is conducted within predefined adaptation boundaries to preserve the intervention's core clinical components and support consistency across participants.
Participants assigned to the intervention arm receive seven planned contacts over approximately four months. Face-to-face contacts occur at Visits 1, 3, 5, and 7, while telephone contacts occur at Visits 2, 4, and 6.
Visit 1 includes the baseline assessment and initial intervention contact, as specified in the study protocol. Visit 7 includes the final post-intervention assessment and the planned final intervention contact. HERDA is delivered alongside standard psychiatric care, which continues throughout the study period. The control group receives standard psychiatric care according to the study protocol.
HERDA uses culturally adapted educational materials, including Banjar-language audiovisual education and electronic flipbooks.
Intervention fidelity will be monitored throughout the HERDA intervention period as part of study quality assurance. Before intervention delivery, pharmacist counselors will undergo training and simulation to support standardized intervention delivery. Standardized pharmacist session logbooks, session checklists, supervision, and random internal audits will be used to document and monitor intervention implementation. Recorded indicators will include completion of scheduled intervention contacts, counseling duration, adherence to the HERDA protocol, delivery of applicable core counseling components, appropriate use of the Clinical Decision Matrix and Transtheoretical Model (TTM), use of educational materials when indicated, action planning, follow-up arrangements, patient understanding of key counseling messages, and session documentation.
Each applicable intervention component will be classified as delivered according to protocol, partially delivered, not delivered according to protocol, or not applicable. Safety-protocol compliance, protocol deviations, reasons for incomplete or modified sessions, and corrective actions, where applicable, will be documented separately. Periodic supervision and refresher training will be provided when needed to support consistent intervention delivery. Process evaluation data will be summarized descriptively to characterize intervention delivery and implementation throughout the study period. These monitoring procedures are intended to assess intervention implementation and are not measures of patient medication adherence or evidence of medication ingestion.
As a supplementary process evaluation, the acceptability and implementation of HERDA will also be explored after completion of the intervention through focus group discussions (FGDs) with pharmacist counselors, in-depth interviews with patients and family members, and a satisfaction questionnaire, as specified in the study procedures. Evaluation domains will include perceived benefits, satisfaction, experiences of receiving or delivering the intervention, implementation challenges, and recommendations for improvement. Qualitative data will be analyzed thematically, while questionnaire findings will be summarized descriptively. These findings will be used to characterize intervention acceptability and implementation and to inform interpretation of the study findings. They will be analyzed and interpreted separately from the randomized comparison of clinical and behavioral outcomes and will not constitute formal trial outcome measures.
This randomized controlled trial evaluates whether adding the HERDA pharmacist-led, culturally adapted intervention to standard psychiatric care improves medication adherence among outpatients with depression compared with standard psychiatric care alone. The study is intended to contribute evidence on the implementation of structured, culturally responsive pharmaceutical care for people receiving treatment for depression in Indonesia.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 72 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Gadjah Mada University is the lead sponsor of 63 studies on the registry; 19 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The study population comprises adult outpatients with a clinical diagnosis of depressive disorder who receive care at the study site and are prescribed oral antidepressant medication. Participants must meet all inclusion criteria and none of the exclusion criteria.
Inclusion Criteria:
Exclusion Criteria:
Eligible outpatients will be screened before enrollment. Written informed consent will be obtained before any study-specific procedures are performed.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive the HERDA pharmacist-led, culturally adapted intervention in addition to standard psychiatric care. The intervention consists of seven planned contacts over approximately four months, combining face-to-face sessions and telephone contacts, delivered by trained pharmacists according to the study protocol.
Behavioral: HERDA Pharmacist-Led Culturally Adapted Intervention
Participants receive standard psychiatric care according to the study protocol, without the additional HERDA pharmacist-led intervention.
HERDA is a structured pharmacist-led, culturally adapted behavioral intervention designed to improve medication adherence among outpatients with depression. It integrates Brief Counseling 5A, the Transtheoretical Model (TTM) to tailor counseling to participants' readiness to change, pharmaceutical care, culturally adapted psychoeducation, and a predefined safety pathway for suicide-related concerns. The intervention is delivered by trained pharmacists through seven planned contacts over approximately four months, comprising face-to-face sessions and telephone contacts. Educational materials include Banjar-language audiovisual content and electronic flipbooks. Family or caregiver engagement is included when appropriate and with participant consent. HERDA is delivered in addition to standard psychiatric care and does not replace prescribed treatment or clinical assessment.
Medication Adherence Measured by MARS-5
Medication adherence to antidepressants will be assessed using the five-item Medication Adherence Rating Scale (MARS-5). Each item is scored from 1 (always) to 5 (never), with higher scores indicating better adherence. The total score is the sum of all five items, ranging from 5 to 25. Adherence will be classified as adherent (total score ≥23; coded as 2) or non-adherent (total score \<23; coded as 1), according to the study's prespecified operational definition.
Time frame: Day 0 (baseline), Day 30, Day 60, and Day 120.
Medication Adherence Measured by Pill Count
Medication adherence to antidepressants will be assessed by pill count. Adherence (%) will be calculated as \[(tablets available for use during the assessment interval - tablets remaining at the end of the interval) / (prescribed tablets per day × number of days in the interval)\] × 100%. Participants will be classified as adherent (80%-100%; coded 2) or non-adherent (\<80%; coded 1), according to the study's prespecified criteria. Baseline pill count at V1 (Day 0) will document the initial medication supply. Adherence will be assessed over intervals ending at V3 (Day 30), V5 (Day 60), and V7 (Day 120). Dispensing records, early refills, and carryover tablets will be reconciled to account for available medication and prevent double-counting.
Time frame: Day 0 (baseline), Day 30, Day 60, and Day 120.
Depressive Symptom Severity Measured by PHQ-9
Depressive symptom severity will be assessed using the nine-item Patient Health Questionnaire (PHQ-9), which evaluates the frequency of nine depressive symptoms over the preceding two weeks, including loss of interest or pleasure, depressed mood, sleep disturbances, fatigue, appetite changes, feelings of worthlessness or guilt, concentration difficulties, psychomotor changes, and thoughts of death or self-harm. Each item is scored from 0 (not at all) to 3 (nearly every day), yielding a total score ranging from 0 to 27, with higher scores indicating greater depressive symptom severity. Scores will be interpreted as minimal or no depressive symptoms (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). The PHQ-9 will be administered at Visit 1 (T0, Day 0) and Visit 7 (T4, Day 120).
Time frame: Day 0 (baseline) and Day 120.
Self-Stigma Measured by the Self-Stigma Scale-Short (SSS-S)
Self-stigma among patients with depression will be assessed using the nine-item Self-Stigma Scale-Short (SSS-S), as described by Wu et al. (2015). Each item is rated on a four-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = agree, and 4 = strongly agree. The total score ranges from 9 to 36, with higher scores indicating greater levels of self-stigma. Based on the study's prespecified classification, total scores will be categorized as minimal (9-15), mild (16-22), moderate (23-29), or severe (30-36). The SSS-S will be administered at Visit 1 (T0, Day 0) and Visit 7 (T4, Day 120) to assess self-stigma at baseline and at the end of the intervention period.
Time frame: Day 0 (baseline) and Day 120.
Suicide Risk Assessed Using the MINI ICD-10 Suicidality Module
Suicide risk will be assessed using the six-item MINI ICD-10 suicidality module at V1 (T0, Day 0) and V7 (T4, Day 120). Responses will be classified as low, moderate, or high risk according to the instrument's algorithm. The HERDA Suicide Reflex Pathway will be activated for any safety concern. Moderate or high risk and acute concerns will prompt immediate clinical escalation. Participants with acute concerns will not be left alone while urgent evaluation is arranged. Referrals, safety planning, handover, and follow-up will be documented. Pharmacists will facilitate escalation, while clinical risk management remains the responsibility of qualified healthcare professionals.
Time frame: Day 0 (baseline) and Day 120.
Medication-Related Health Behavior
Depression treatment-related knowledge, beliefs, and behaviors will be assessed using a study-specific 12-item questionnaire comprising three domains: cognitive (knowledge of depression, antidepressant treatment, risk factors, and lifestyle-related factors); affective (beliefs, attitudes, and willingness regarding antidepressant use and smoking-related risks); and behavioral (medication-carrying practices, dietary and smoking-related behavior, physical activity, and intention to discontinue antidepressants when symptoms improve). Each item will be scored as correct (+1) or incorrect (0) according to a predefined answer key, with negatively worded items scored accordingly. Domain-level findings and behavioral readiness will be interpreted according to the study's prespecified scoring criteria and Transtheoretical Model-based operational definitions. The questionnaire will be administered at V1 (T0, Day 0), V3 (T1, Day 30), V5 (T2, Day 60), and V7 (T4, Day 120).
Time frame: Day 0 (baseline), Day 30, Day 60, and Day 120.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — The decision regarding individual participant data (IPD) sharing has not yet been finalized. This study collects sensitive information on depression, antidepressant medication adherence, self-stigma, and suicide risk. The feasibility of sharing de-identified IPD will be reviewed after considering the research ethics approval, informed consent provisions, applicable data protection requirements, and institutional policies. Any future data-sharing plan will specify the data to be shared, access criteria, timing, and procedures for protecting participant confidentiality. No commitment to share IPD has been made at this stage.
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 active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Gadjah Mada University