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

Primary Purpose

Depression

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
self-monitoring
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring depression, treatment initiation, treatment adherence, treatment utilization

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • James A. Haley Veterans' Hospital, Tampa, FL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self-monitoring

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2023
Last Updated
September 21, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05990075
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 13, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, treatment initiation, treatment adherence, treatment utilization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study employs a single group design given its focus on feasibility and acceptability.
Masking
None (Open Label)
Masking Description
The primary goal of the study is feasibility and acceptability of methods.
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
self-monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability as assessed by rate of initiation and completion of the intervention
Description
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.
Time Frame
From date of referral to date of initial psychotherapy session, up to 30 weeks.
Title
Feasibility as assessed by rate of completion of individual tasks within intervention
Description
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.
Time Frame
From date of referral to date of initial psychotherapy session, up to 30 weeks.
Other Pre-specified Outcome Measures:
Title
Effectiveness of intervention as assessed by rate of depression treatment initiation and adherence
Description
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.
Time Frame
Date of initiation of psychotherapy up to 30 weeks.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Panaite, PhD
Organizational Affiliation
James A. Haley Veterans' Hospital, Tampa, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
James A. Haley Veterans' Hospital, Tampa, FL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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