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| ID | Type | Description | Link |
|---|---|---|---|
| IK2HX002899-01A2 | U.S. NIH Grant/Contract | View source |
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Depression is the most prevalent mental health condition among VHA patients and is strongly associated with poor functioning, negative health outcomes, and suicide. Despite effective and available treatments, engagement in care is poor. This study will analyze VHA electronic medical record data, to identify patient characteristics associated with poor treatment engagement. The study will then develop and formatively evaluate an eHealth intervention to improve and sustain engagement in mental health care through self-monitoring. This is an important step in engaging Veterans who, in part, based on their military training, may have difficulty identifying or accepting depressed affect and the benefits of treatment. The information obtained will inform clinical strategies and operations policy to improve quality, coordination, and efficiency of mental health services.
My goal is to optimize treatment outcomes for Veterans with depression. To experience positive outcomes, Veterans must begin care promptly when needed and remain engaged in care. Depression imposes a great burden of illness and disability for the OEF/OIF Veteran population. As few as 30% of Veterans initiate treatment after referrals for mental health services and adherence after initiation is low. Untreated depression is strongly linked to suicide mortality, drug abuse, and persistent impairment leading to poor health outcomes. The VHA has focused on increasing access to evidence-based treatments (EBTs) as the gold standard for treating depression, however the guidelines do not address Veterans who are lost to care. This is a missed opportunity to engage Veterans who fail to initiate traditional treatment or drop out early, often due to discomfort and lack of awareness of certain depression symptoms or need for care, which translates to reduced self-efficacy to engage. Furthermore, measurement-based care-the utilization of systematic symptom assessments over time to drive changes in treatment-is recommended for care in VHA. Patients at risk for dropping out of care may find systematic assessments acceptable and effective for supporting engagement in EBTs if their symptoms persist.
This study addresses treatment initiation and adherence among depressed Veterans who are referred to mental health care. Specifically, the investigators will test an innovative self-monitoring program for Veterans with depression which has the potential to facilitate both treatment uptake and sustained engagement. The proposed research will test a patient centered, self-monitoring eHealth intervention focused on systematic measurement and feedback for Veterans with depression, as well as supportive messages providing VA related information and coping strategies that Veterans elect.
The intervention will be initiated when patients are referred for care. This program will continue to help Veterans monitor during treatment if they so desire, as self-monitoring has been found to increase the likelihood of treatment response. The objectives of this study are to formatively evaluate this process and provide preliminary support to then evaluate the efficacy/effectiveness of this intervention in a future study.
This project is aligned with the VHA HSR&D priorities in mental health and improving access to care and high-priority research topics for mental and behavioral health. Findings from this study have the potential to lead to transdiagnostic research, especially for PTSD, TBI, and suicide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-monitoring | Experimental | This research study will evaluate a self-monitoring intervention to increase awareness, provide support, and promote motivation to initiate treatment after referral to mental health. The proposed intervention is a user-driven program delivered online and by mobile text. This will be initially piloted for acceptability among Veterans referred to mental health service for depression treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self-monitoring | Behavioral | This research study will evaluate a self-monitoring intervention to increase awareness, provide support, and promote motivation to initiate treatment after referral to mental health. The proposed intervention is a user-driven program delivered online and by mobile text. This will be initially piloted for acceptability among Veterans referred to mental health service for depression treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Intervention Enrollment as Assessed by Completion of Baseline Survey. | Intervention enrollment was measured by completion of baseline survey which entailed patients' explicit agreement to participate in the intervention. | Up to 30 weeks. |
| Percent Patients With Completed Tasks as Measured by Mental Health Link. | Mental Health Link asks patients to report on 24 hour positive and negative events, emotions, and depression symptoms. | Immediately after intervention completion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Intervention as Assessed by Rate of Depression Treatment Initiation and Adherence | The investigators will evaluate % mental health treatment initiation relative to the general population in the same clinics. This measure is experimental given that efficacy is not yet the focus of this work given its preliminary stage. Treatment initiation is defined as initial mental health appointment being completed. Treatment adherence is defined as continuing treatment past initiation. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Panaite, PhD | Edward Hines Jr. VA Hospital, Hines, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | 60141-3030 | United States |
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Of those who met inclusion criteria, 47 patients agreed to participation and enrolled in the study.
Participants were recruited based on physician referrals to specialty mental health clinics for depressive disorders and depressive symptoms between September 2023-September 2024. Prior to enrollment, participant clinical charts were screened.
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-monitoring | This research study will evaluate a self-monitoring intervention to increase awareness, provide support, and promote motivation to initiate treatment after referral to mental health. The proposed intervention is a user-driven program delivered online and by mobile text. This will be initially piloted for acceptability among Veterans referred to mental health service for depression treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-monitoring | This research study will evaluate a self-monitoring intervention to increase awareness, provide support, and promote motivation to initiate treatment after referral to mental health. The proposed intervention is a user-driven program delivered online and by mobile text. This will be initially piloted for acceptability among Veterans referred to mental health service for depression treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Intervention Enrollment as Assessed by Completion of Baseline Survey. | Intervention enrollment was measured by completion of baseline survey which entailed patients' explicit agreement to participate in the intervention. | The denominator for this analysis were participants who were pre-screened, met study criteria, and were invited to participate in the intervention. | Posted | Count of Participants | Participants | Up to 30 weeks. |
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From enrollment until end of follow-up, up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-monitoring | This research study will evaluate a self-monitoring intervention to increase awareness, provide support, and promote motivation to initiate treatment after referral to mental health. The proposed intervention is a user-driven program delivered online and by mobile text. This will be initially piloted for acceptability among Veterans referred to mental health service for depression treatment. |
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This is a pilot study of an experimental technology based tool designed to help patients stay engaged after referral to mental health services. Sample size limits power for more complex analyses. Furthermore patients were allowed to engage with this tool as needed, and therefore data collected over time is highly variable, contributing to limitations for data analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Panaite, PhD | James A. Haley Veterans' Hospital | 813-768-2193 | vanessa.panaite2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 9, 2021 | Sep 26, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2022 | Sep 26, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2023 | Oct 15, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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The study employs a single group design given its focus on feasibility and acceptability.
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The primary goal of the study is feasibility and acceptability of methods.
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| Immediately after intervention, up to 30 weeks. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Service Connected (%) | Count of Participants | Participants |
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| Service Connected for Mental Health | Count of Participants | Participants |
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| Barriers to Accessing Care Evaluation (BACE) | BACE is a comprehensive measure that identifies stigma, access, and practical barriers individuals face when seeking mental health. Items are scored on a 0 (Not at all) to 3 (A lot) scale. | Mean | Standard Deviation | Units on a scale |
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| Affective Control Scale (ACS) | ACS measures fear of losing control over one's negative and positive emotions or of one's behavioral reactions to these emotions. Items are scores on a 1 (Very Strongly Disagree) to 7 (Very Strongly Agree) scale. | Mean | Standard Deviation | Units on a scale |
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| Patient Health Questionnaire 8 (PHQ8) | PHQ8 assesses depression related symptoms on a 0 = Not at all 1 = Several days 2 = More than half the days 3 = Nearly every day scale. Scores range from 0 to 24 with higher scores indicating higher depression symptoms. | Mean | Standard Deviation | Units on a scale |
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| Primary | Percent Patients With Completed Tasks as Measured by Mental Health Link. | Mental Health Link asks patients to report on 24 hour positive and negative events, emotions, and depression symptoms. | Posted | Count of Participants | Participants | Immediately after intervention completion. |
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| Other Pre-specified | Efficacy of Intervention as Assessed by Rate of Depression Treatment Initiation and Adherence | The investigators will evaluate % mental health treatment initiation relative to the general population in the same clinics. This measure is experimental given that efficacy is not yet the focus of this work given its preliminary stage. Treatment initiation is defined as initial mental health appointment being completed. Treatment adherence is defined as continuing treatment past initiation. | Denominator for treatment adherence is number of patients who initiated treatment. | Posted | Count of Participants | Participants | Immediately after intervention, up to 30 weeks. |
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| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
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| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Treatment adherence (4+ sessions) |
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