Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217198
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-01-11
Brief Title:
A Computerized Depression Intervention in Veterans
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Randomized Controlled Trial of Deprexis Evaluation of A Computerized Intervention to Decrease Depression and Restore Functioning in Veterans
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Deprexis
Brief Summary:
Depressive symptoms are common among Veterans and associated with significant impairment Timely intervention has the potential to improve mental health outcomes and restore functioning Interventions delivered through the internet can be completed remotely at any time and thus minimize burden on Veterans however the research examining their utility in Veterans is limited This proposed project will examine Deprexis a self-guided internet-delivered intervention which targets depressive symptoms and associated functional impairments Interviews will be conducted to gain insight into Veterans perceptions needs and preferences vis-a-vis Deprexis with results informing a randomized controlled trial Here an 8-week course of Deprexis will be compared to a treatment-as-usual TAU control condition to establish if Deprexis is acceptable and effective for Veterans with mild to moderate depressive symptoms Veterans engaged in Deprexis are hypothesized to show improvements on measures of functioning and decreases in depressive symptoms compared to the TAU control group The proposed work has great clinical utility as it could provide a readily accessible high-quality intervention for the many Veterans suffering from depressive symptoms with the potential to improve functioning and long-term outcomes
Detailed Description:
Depressive symptoms are common in Veterans and are highly predictive of disability and impairment in quality of life Providing timely intervention for depressive illness can prevent chronic Major Depressive Disorder MDD and entrenched functional impairments Preventing the progression into severe and recurrent disease and disability is essential MDD is the second strongest predictor of Veteran suicide among all recorded mental health diagnoses and functional impairments associated with mental health diagnoses increase the risk for suicide Depressive symptoms strongly predict functional impairment in Veterans independent of other debilitating mental health conditions including PTSD These findings suggest that depressive symptoms should be an urgent target of intervention even in the context of complex or comorbid presentations to improve functioning and mitigate suicide risk
The VA healthcare system is uniquely positioned to identify and treat mild-moderate depressive symptoms because depression symptom screenings are routinely performed in primary care and specialty clinics however Veterans still experience various barriers to care These barriers include shame around depression and stigma associated with seeking mental health treatment lack of availability of mental health services as well as difficulties attending mental health treatments due to lack of time However the VA is well-suited to intervene at both institutional and individual barriers to care to provide accessible timely and acceptable treatments for depressive symptoms using scalable low-cost computer-delivered interventions
Although internet-delivered interventions have the potential to optimize treatment access and utilization for Veterans with mild-moderate depressive symptoms the research examining the effectiveness of internet-delivered psychological intervention for Veterans is still in its nascence Deprexis a self-guided internet-delivered intervention improved well-being and decreased depressive symptoms and disability in a general population sample However Deprexis has not yet been rigorously evaluated with a Veteran population in a VA medical center setting The current study aims to fill this critical gap in the literature by pursuing the following aims
Aim 1 To assess Veterans perceptions needs and preferences in relation to Deprexis through conducting qualitative assessments interviews with a subset of Veterans enrolled in Deprexis n16-20 Research question Which potentially modifiable components improve Veterans experience and uptake of Deprexis This data will be used to inform potential changes to content and study delivery in the RCT
Aim 2a To test whether Deprexis is effective for decreasing depressive symptoms and improving functional outcomes in Veterans n132 presenting for VHA healthcare with mild-moderate depressive symptoms A randomized controlled trial comparing an 8-week course of Deprexis to a treatment-as-usual control condition will be conducted Veterans with a positive screen for depression will be identified through the medical record and those with a depression symptom severity score in the mild-moderate range will be invited to participate in the study Depression symptom severity scores and clinically meaningful outcomes measures of functioning disability and quality of life will be collected at baseline post-treatment and 8-week follow-up Hypothesis Veterans engaged in Deprexis will show improvements on measures of functioning and decreases in depressive symptoms compared to the TAU control group To generate hypotheses for future study exploratory Aim 2b will examine if demographic variables baseline psychopathology credibility and Deprexis usage moderate treatment effects on primary outcomes
Impact Consistent with the Rehabilitation Research and Development Service aim to maximize functional recovery in Veterans the proposed study could provide evidence for a rapid high-quality and low-barrier intervention for Veterans with depressive symptoms with the potential to attenuate suicide risk functional disability and impairment in quality of life
The VA healthcare system is uniquely positioned to identify and treat mild-moderate depressive symptoms because depression symptom screenings are routinely performed in primary care and specialty clinics however Veterans still experience various barriers to care These barriers include shame around depression and stigma associated with seeking mental health treatment lack of availability of mental health services as well as difficulties attending mental health treatments due to lack of time However the VA is well-suited to intervene at both institutional and individual barriers to care to provide accessible timely and acceptable treatments for depressive symptoms using scalable low-cost computer-delivered interventions
Although internet-delivered interventions have the potential to optimize treatment access and utilization for Veterans with mild-moderate depressive symptoms the research examining the effectiveness of internet-delivered psychological intervention for Veterans is still in its nascence Deprexis a self-guided internet-delivered intervention improved well-being and decreased depressive symptoms and disability in a general population sample However Deprexis has not yet been rigorously evaluated with a Veteran population in a VA medical center setting The current study aims to fill this critical gap in the literature by pursuing the following aims
Aim 1 To assess Veterans perceptions needs and preferences in relation to Deprexis through conducting qualitative assessments interviews with a subset of Veterans enrolled in Deprexis n16-20 Research question Which potentially modifiable components improve Veterans experience and uptake of Deprexis This data will be used to inform potential changes to content and study delivery in the RCT
Aim 2a To test whether Deprexis is effective for decreasing depressive symptoms and improving functional outcomes in Veterans n132 presenting for VHA healthcare with mild-moderate depressive symptoms A randomized controlled trial comparing an 8-week course of Deprexis to a treatment-as-usual control condition will be conducted Veterans with a positive screen for depression will be identified through the medical record and those with a depression symptom severity score in the mild-moderate range will be invited to participate in the study Depression symptom severity scores and clinically meaningful outcomes measures of functioning disability and quality of life will be collected at baseline post-treatment and 8-week follow-up Hypothesis Veterans engaged in Deprexis will show improvements on measures of functioning and decreases in depressive symptoms compared to the TAU control group To generate hypotheses for future study exploratory Aim 2b will examine if demographic variables baseline psychopathology credibility and Deprexis usage moderate treatment effects on primary outcomes
Impact Consistent with the Rehabilitation Research and Development Service aim to maximize functional recovery in Veterans the proposed study could provide evidence for a rapid high-quality and low-barrier intervention for Veterans with depressive symptoms with the potential to attenuate suicide risk functional disability and impairment in quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1IK2RX004565 | NIH | Department of Veterans Affairs | httpsreporternihgovquickSearch1IK2RX004565 |