Depression
Conditions
Keywords
depression, treatment initiation, treatment adherence, treatment utilization
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.
Interventions
BEHAVIORALself-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.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
The primary goal of the study is feasibility and acceptability of methods.
Intervention model description
The study employs a single group design given its focus on feasibility and acceptability.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intervention Enrollment as Assessed by Completion of Baseline Survey. | Up to 30 weeks. | Intervention enrollment was measured by completion of baseline survey which entailed patients' explicit agreement to participate in the intervention. |
| Percent Patients With Completed Tasks as Measured by Mental Health Link. | Immediately after intervention completion. | Mental Health Link asks patients to report on 24 hour positive and negative events, emotions, and depression symptoms. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVanessa Panaite, PhD
Edward Hines Jr. VA Hospital, Hines, IL
Participant flow
Recruitment details
Participants were recruited based on physician referrals to specialty mental health clinics for depressive disorders and depressive symptoms between September 2023-September 2024. Prior to enrollment, participant clinical charts were screened.
Pre-assignment details
Of those who met inclusion criteria, 47 patients agreed to participation and enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Self-monitoring |
|---|---|
| Affective Control Scale (ACS) Fear of anger | 4.20 Units on a scale STANDARD_DEVIATION 1.11 |
| Affective Control Scale (ACS) Fear of anxiety | 4.39 Units on a scale STANDARD_DEVIATION 1.05 |
| Affective Control Scale (ACS) Fear of depression | 4.19 Units on a scale STANDARD_DEVIATION 0.97 |
| Affective Control Scale (ACS) Fear of positive emotions | 3.47 Units on a scale STANDARD_DEVIATION 0.91 |
| Age, Continuous | 43 years STANDARD_DEVIATION 9 |
| Barriers to Accessing Care Evaluation (BACE) Access and practical barriers | 1.04 Units on a scale STANDARD_DEVIATION 0.5 |
| Barriers to Accessing Care Evaluation (BACE) Stigma related barriers | 0.64 Units on a scale STANDARD_DEVIATION 0.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Marital status Divorced | 11 Participants |
| Marital status Married | 21 Participants |
| Marital status Never Married | 11 Participants |
| Marital status Separated | 3 Participants |
| Marital status Unknown | 1 Participants |
| Patient Health Questionnaire 8 (PHQ8) | 15.34 Units on a scale STANDARD_DEVIATION 5.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Service Connected (%) 0% | 4 Participants |
| Service Connected (%) 100% | 21 Participants |
| Service Connected (%) 10-50% | 5 Participants |
| Service Connected (%) 60-90% | 17 Participants |
| Service Connected for Mental Health No | 14 Participants |
| Service Connected for Mental Health Yes | 33 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
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.
Time frame: Up to 30 weeks.
Population: The denominator for this analysis were participants who were pre-screened, met study criteria, and were invited to participate in the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-monitoring | Incidence of Intervention Enrollment as Assessed by Completion of Baseline Survey. | 47 Participants |
Primary
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.
Time frame: Immediately after intervention completion.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self-monitoring | Percent Patients With Completed Tasks as Measured by Mental Health Link. | Engagement with intervention | 47 Participants |
| Self-monitoring | Percent Patients With Completed Tasks as Measured by Mental Health Link. | > 50% engagement rate | 25 Participants |
Other Pre-specified
Efficacy 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 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.
Time frame: Immediately after intervention, up to 30 weeks.
Population: Denominator for treatment adherence is number of patients who initiated treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self-monitoring | Efficacy of Intervention as Assessed by Rate of Depression Treatment Initiation and Adherence | Treatment initiation | 32 Participants |
| Self-monitoring | Efficacy of Intervention as Assessed by Rate of Depression Treatment Initiation and Adherence | Treatment adherence (1+ sessions) | 28 Participants |
| Self-monitoring | Efficacy of Intervention as Assessed by Rate of Depression Treatment Initiation and Adherence | Treatment adherence (4+ sessions) | 18 Participants |