Clinical trial NCT05990075: An eHealth Intervention to Increase Depression Treatment Initiation and Adherence Among Veterans Referred for Mental Health Services
Official title: An eHealth Intervention to Increase Depression Treatment Initiation and Adherence Among Veterans Referred for Mental Health Services (CDA 18-189)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Keywords: depression
treatment initiation
treatment adherence
treatment utilization
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-08-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study employs a single group design given its focus on feasibility and acceptability.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Acceptability as assessed by rate of initiation and completion of the intervention
timeFrame: From date of referral to date of initial psychotherapy session, up to 30 weeks.
measure: Feasibility as assessed by rate of completion of individual tasks within intervention
timeFrame: From date of referral to date of initial psychotherapy session, up to 30 weeks.
Secondary outcomes:
Other outcomes:
measure: Efficacy of intervention as assessed by rate of depression treatment initiation and adherence
timeFrame: Date of initiation of psychotherapy up to 30 weeks.
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
Study officials:
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
name: Vanessa Panaite, PhD
role: PRINCIPAL_INVESTIGATOR
References: