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

Depression Clinical Trial

Official title:

An eHealth Intervention to Increase Depression Treatment Initiation and Adherence Among Veterans Referred for Mental Health Services (CDA 18-189)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05990075
• Other study ID #: CDX 21-002
• Secondary ID: IK2HX002899-01A2
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: September 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: May 31, 2026
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

• All ages 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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effectiveness 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 effectiveness is not yet the focus of this work given its preliminary stage.	Date of initiation of psychotherapy up to 30 weeks.
Primary	Acceptability as assessed by rate of initiation and completion of the intervention	Acceptability will be measured by number of Veterans who agree to participate in the study and initiate the intervention. This measure will also capture the % completion of the intervention.	From date of referral to date of initial psychotherapy session, up to 30 weeks.
Primary	Feasibility as assessed by rate of completion of individual tasks within intervention	Feasibility will be measured by rate of completion of each task of the proposed intervention (surveys, texts), rate of technical difficulties, and rate of incomplete data.	From date of referral to date of initial psychotherapy session, up to 30 weeks.