DepressionDeprexisNCT06217198
A Computerized Depression Intervention in Veterans
A study testing Deprexis in people with Depression, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Deprexis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potential participants include male and female Veterans of all races/ethnicities who are:
- able to comprehend and sign the informed consent form
- have reliable access to the internet and a computer, tablet and/or smartphone
- exhibit mild or moderate, but not very severe, levels of depression
- stable on psychotropic medications
Who cannot join
- Aim 1 and Aim 2: Veterans will be excluded from study participation if they:
- endorse any positive symptoms of a psychotic disorder
- screen positive for Bipolar I Disorder
- report current suicidal risk
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
Waco, Texas, 76711
Rakesh Guleria, (254) 297-3291, rakeshwar.guleria@va.gov
Lance Starzyk, BAAS AA, (254) 743-2409, Lance.Starzyk@va.gov
About this study
Official title: A Randomized Controlled Trial of Deprexis; Evaluation of A Computerized Intervention to Decrease Depression and Restore Functioning in Veterans
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.
Read the 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 (n=16-20). 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 (n=132) 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.
- Conditions
- Depression
- Being tested
- Deprexis
- Keywords
- Internet-Based Intervention, Cognitive-Behavioral Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeprexisBehavioural
Deprexis is an internet-delivered treatment for depressive symptoms and related functional impairment. The intervention draws from various theoretical frameworks and consists of 12 modules: 10 core content modules and an introductory and summary module. Deprexis is designed to be interactive, includes answering questions and learning techniques and concepts through instruction and examples.
| Study group | Role | What they receive |
|---|---|---|
| Deprexis | Experimental | Deprexis: an internet-delivered psychosocial treatment for depressive symptoms and related functional impairment. Receives: Behavioral: Deprexis |
| Treatment-as-Usual | No intervention | Access to standard non-study care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptomatology (Self-Report; QIDS-SR-16) Change
The Quick Inventory of Depressive Symptomatology (Self-Report; QIDS-SR-16) is a 16-item self-report measure of depressive symptom severity. This brief measure assesses the 9 DSM-IV symptom criterion domains for depression and has been shown to be highly reliable, internally consistent and sensitive to symptom change. QIDS-SR-16 scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: Baseline, Post-Treatment (week 8), Follow-up (week 16)
World Health Organization Disability Assessment Schedule-II (WHODAS) Change
The World Health Organization Disability Assessment Schedule-II (WHODAS) is a 36-item questionnaire assessing functional disability across 7 domains (understanding and communicating, getting around, getting along with people, life activities, work, participation in society, self-care) as well as a total score. The WHODAS has high test-retest reliability (r=0.98) and concurrent and construct validity. WHODAS scores range from 0 to 100, with higher scores indicating greater disability
Measured: Baseline, Post-Treatment (week 8), Follow-up (week 16)
The Sheehan Disability Scale (SDS) Change
The Sheehan Disability Scale (SDS) is a 3-item self-report measure of symptom-related disability, which has been used in previous Deprexis trials. The SDS was developed as a global measure of the impact of mental illness on work/school activities, family relationships and social functioning. The SDS has been found to be internally consistent, reliable and to have high construct validity and to be sensitive to treatment effects. SDS scores range from 0 to 30, with higher scores indicating greater functional impairment.
Measured: Baseline, Post-Treatment (week 8), Follow-up (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 May 2024
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rahel R Pearson, PhD, Principal investigator, Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217198
- Sponsor's protocol ID
- D4565-W
- Other IDs
- 1IK2RX004565
- Acronym
- Deprexis
- Status last verified
- Aug 2026
- First submitted
- 11 Jan 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
Publications
Pearson R, Harris E, Metts A, Beevers CG, Pfeiffer PN, Creech S. Deprexis for Veteran Depression: Open-Label Pilot Trial Examining Feasibility, Acceptability, and Preliminary Efficacy. JMIR Form Res. 2026 Jul 21;10:e86899. doi: 10.2196/86899.
PubMed 42480022Pearson R, Beevers CG, Mignogna J, Benzer J, Pfeiffer PN, Post E, Creech SK. The Evaluation of a Web-Based Intervention (Deprexis) to Decrease Depression and Restore Functioning in Veterans: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 24;13:e59119. doi: 10.2196/59119.
PubMed 39446432
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Deprexis; Evaluation of A Computerized Intervention to Decrease Depression and Restore Functioning in Veterans
- ClinicalTrials.gov ID
- NCT06217198
- Acronym / sponsor ID
- Deprexis / D4565-W
- Conditions
- Depression
- Keywords
- Internet-Based Intervention, Cognitive-Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (n=16-20). 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 (n=132) 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Deprexis | Experimental | Behavioral: DeprexisDeprexis: an internet-delivered psychosocial treatment for depressive symptoms and related functional impairment. |
| Treatment-as-Usual | No intervention | –Access to standard non-study care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- able to comprehend and sign the informed consent form
- have reliable access to the internet and a computer, tablet and/or smartphone
- exhibit mild or moderate, but not very severe, levels of depression
- stable on psychotropic medications
Key exclusion criteria (4 listed)
- endorse any positive symptoms of a psychotic disorder
- screen positive for Bipolar I Disorder
- report current suicidal risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeprexisDeprexis is an internet-delivered treatment for depressive symptoms and related functional impairment. The intervention draws from various theoretical frameworks and consists of 12 modules: 10 core content modules and an introductory and summary module. Deprexis is designed to be interactive, includes answering questions and learning techniques and concepts through instruction and examples. | Behavioural | Deprexis |
Primary outcome
Quick Inventory of Depressive Symptomatology (Self-Report; QIDS-SR-16) Change
Time frame: Baseline, Post-Treatment (week 8), Follow-up (week 16)
The Quick Inventory of Depressive Symptomatology (Self-Report; QIDS-SR-16) is a 16-item self-report measure of depressive symptom severity. This brief measure assesses the 9 DSM-IV symptom criterion domains for depression and has been shown to be highly reliable, internally consistent and sensitive to symptom change. QIDS-SR-16 scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
World Health Organization Disability Assessment Schedule-II (WHODAS) Change
Time frame: Baseline, Post-Treatment (week 8), Follow-up (week 16)
The World Health Organization Disability Assessment Schedule-II (WHODAS) is a 36-item questionnaire assessing functional disability across 7 domains (understanding and communicating, getting around, getting along with people, life activities, work, participation in society, self-care) as well as a total score. The WHODAS has high test-retest reliability (r=0.98) and concurrent and construct validity. WHODAS scores range from 0 to 100, with higher scores indicating greater disability
The Sheehan Disability Scale (SDS) Change
Time frame: Baseline, Post-Treatment (week 8), Follow-up (week 16)
The Sheehan Disability Scale (SDS) is a 3-item self-report measure of symptom-related disability, which has been used in previous Deprexis trials. The SDS was developed as a global measure of the impact of mental illness on work/school activities, family relationships and social functioning. The SDS has been found to be internally consistent, reliable and to have high construct validity and to be sensitive to treatment effects. SDS scores range from 0 to 30, with higher scores indicating greater functional impairment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Derived from this study: PubMed 42480022Pearson R, Harris E, Metts A, Beevers CG, Pfeiffer PN, Creech S. Deprexis for Veteran Depression: Open-Label Pilot Trial Examining Feasibility, Acceptability, and Preliminary Efficacy. JMIR Form Res. 2026 Jul 21;10:e86899. doi: 10.2196/86899.
- Derived from this study: PubMed 39446432Pearson R, Beevers CG, Mignogna J, Benzer J, Pfeiffer PN, Post E, Creech SK. The Evaluation of a Web-Based Intervention (Deprexis) to Decrease Depression and Restore Functioning in Veterans: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 24;13:e59119. doi: 10.2196/59119.
- Individual participant dataSharing planned: No. A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahel R Pearson, PhD principal investigator
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deprexis in people with Depression, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahel R Pearson, PhD ((254) 297-5155, rahel.pearson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory of Depressive Symptomatology (Self-Report; QIDS-SR-16) Change (time frame: Baseline, Post-Treatment (week 8), Follow-up (week 16)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06217198, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.