- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05990075
An eHealth Intervention to Increase Depression Treatment Initiation and Adherence Among Veterans Referred for Mental Health Services
An eHealth Intervention to Increase Depression Treatment Initiation and Adherence Among Veterans Referred for Mental Health Services (CDA 18-189)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- James A. Haley Veterans' Hospital, Tampa, FL
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Veteran status
- Recent referral to VA general mental health clinics providing psychotherapy for depression
- No gender or minorities will be excluded from this study
- 18-64 will be included
Exclusion Criteria:
- Current/Past Bipolar disorder and Current Psychotic disorder: to avoid potential exacerbation from treatment for depression
- Alcohol Use disorder or Substance Use disorder: Depression treatments cannot reverse the adverse effects of substances on mood, and therefore impact on adherence and treatment characteristics may be confounded
- Other current severe or unstable, psychiatric and medical disorders that necessitates clinical management that can confound results (e.g., cancer [in chemotherapy], suicidality, recent hospitalization [medical/surgical] for which recovery overlaps with study onset and duration, open skull/brain injury, moderate to severe TBI)
- Moderate to severe cognitive impairment (SLUMS 20 and/or diagnosis in medical record)
- Potentially temporary states/situations that may significantly impair mood/capability to engage in treatment: unstable environment that is not in one's control (e.g., homeless, temporary group home, extensive care taking duties)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Intervention Enrollment as Assessed by Completion of Baseline Survey.
Time Frame: Up to 30 weeks.
|
Intervention enrollment was measured by completion of baseline survey which entailed patients' explicit agreement to participate in the intervention.
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Up to 30 weeks.
|
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Percent Patients With Completed Tasks as Measured by Mental Health Link.
Time Frame: Immediately after intervention completion.
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Mental Health Link asks patients to report on 24 hour positive and negative events, emotions, and depression symptoms.
|
Immediately after intervention completion.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of Intervention as Assessed by Rate of Depression Treatment Initiation and Adherence
Time Frame: Immediately after intervention, up to 30 weeks.
|
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.
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Immediately after intervention, up to 30 weeks.
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Collaborators and Investigators
Investigators
- Principal Investigator: Vanessa Panaite, PhD, James A. Haley Veterans' Hospital, Tampa, FL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Behavior
- Health Behavior
- Depression
- Treatment Adherence and Compliance
- Investigative Techniques
- Therapeutics
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Blood Chemical Analysis
- Clinical Chemistry Tests
- Diagnostic Techniques, Endocrine
- Monitoring, Physiologic
- Self-Testing
- Self Care
- Blood Glucose Self-Monitoring
Other Study ID Numbers
- CDX 21-002
- IK2HX002899-01A2 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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