An eHealth Intervention to Increase Depression Treatment Initiation and Adherence Among Veterans Referred for Mental Health Services

NCT05990075 | Active Not Recruiting Results DMC

• 2 other identifiers: CDX 21-002IK2HX002899-01A2
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

depression; treatment initiation; treatment adherence; treatment utilization

Outcome Measures

Primary Outcomes (2)

• 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.

Other Outcomes (1)

• Efficacy of Intervention as Assessed by Rate of Depression Treatment Initiation and Adherence

  Immediately after intervention, up to 30 weeks.

Study Arms (1)

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.

Behavioral: self-monitoring

Interventions

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.

Self-monitoring

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Veteran status
• Recent referral to VA general mental health clinics providing psychotherapy for depression
• No gender or minorities will be excluded from this study
• will be included

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Depression; Treatment Adherence and Compliance

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Limitations and Caveats

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.

Results Point of Contact

• Title: Vanessa Panaite, PhD
• Organization: James A. Haley Veterans' Hospital

vanessa.panaite2@va.gov

813-768-2193

Study Officials

• Vanessa Panaite, PhD

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The primary goal of the study is feasibility and acceptability of methods.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The study employs a single group design given its focus on feasibility and acceptability.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: September 13, 2023
• Primary Completion: September 30, 2024
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 20, 2026
• Results First Posted: November 21, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)