HERDA: Pharmacist-Led Culturally Adapted Intervention for Depression Medication Adherence
NCT07915427, Not applicable, Active not recruiting, Gadjah Mada University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | HERDA: Pharmacist-Led Culturally Adapted Intervention for Depression Medication Adherence | ClinicalTrials.gov |
| NCT number | NCT07915427 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 72 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Gadjah Mada University | ClinicalTrials.gov |
| Conditions | Depression | ClinicalTrials.gov |
| Interventions | HERDA Pharmacist-Led Culturally Adapted Intervention | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Medication Adherence Measured by MARS-5 | Day 0 (baseline), Day 30, Day 60, and Day 120. | 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. | ClinicalTrials.gov |
| Primary | Medication Adherence Measured by Pill Count | Day 0 (baseline), Day 30, Day 60, and Day 120. | 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. | ClinicalTrials.gov |
| Secondary | Depressive Symptom Severity Measured by PHQ-9 | Day 0 (baseline) and Day 120. | 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). | ClinicalTrials.gov |
| Secondary | Self-Stigma Measured by the Self-Stigma Scale-Short (SSS-S) | Day 0 (baseline) and Day 120. | 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. | ClinicalTrials.gov |
| Secondary | Suicide Risk Assessed Using the MINI ICD-10 Suicidality Module | Day 0 (baseline) and Day 120. | 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. | ClinicalTrials.gov |
| Secondary | Medication-Related Health Behavior | Day 0 (baseline), Day 30, Day 60, and Day 120. | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)