Major Depressive DisorderCogRemVetNCT04952532

A Novel Cognitive Remediation Intervention Targeting Poor Decision-making and Depression in Veterans at High Risk for Suicide: A Safe, Telehealth Approach During the COVID-19 Pandemic

A study testing Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed Cognitive Remediation plus Bridging) in people with Major Depressive Disorder, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed Cognitive Remediation plus Bridging)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2022to 31 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

U.S. Veteran;
Primary diagnosis of major depressive disorder (MDD) and a history of suicide attempt in the past year;
Elevated score (>1SD above the normal mean) on rumination measure (Ruminative Response Scale);
Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) current suicidal ideation (either passive, i.e. "wish to be dead") or active ideation but with no intent to act on it immediately and no specific plan;
Currently in psychotherapy treatment as usual (TAU) at the James J. Peters VA Medical Center.
The investigators will include women and aim for the sample to be 30% women.

Who cannot join

Current substance use disorder;
History of traumatic brain injury; neurological disorder, or other medical confound; compromised intellectual abilities (WASI45 FSIQ<70)
The investigators will enroll six Veterans in each group and conduct six 10-week intervention cycles for a total sample of 36 Veterans.

Trial locations and contacts

1 site in 1 country.

United States1 site

James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468-3904

Other trials in United States

About this study

Official title: A Novel Cognitive Remediation Intervention Targeting Poor Decision-Making and Depression in Veterans at High Risk for Suicide: A Safe, Telehealth Approach During the COVID-19 Pandemic

Despite large-scale, nationwide efforts to better address suicidal behavior in Veterans at high risk, the development of interventions that target some of the key risk factors associated with suicide remains limited. This study aims to collect pilot data to test feasibility/acceptability of a novel adjunctive evidence-based cognitive remediation (CR) therapy with manualized "Bridging" sessions for transfer and practice of problem-solving strategies for real-world stressors, including those that trigger suicidal thoughts. This 10-week (20 session) Neuropsychological Educational Approach to Cognitive Remediation CR+Bridging telehealth intervention will be administered virtually via HIPPA-compliant services to 36 Veterans with major depressive disorder and a history of suicide attempt(s). Pre-, post-treatment, and follow-up assessments of neurocognitive, clinical, social, and real-world functioning also will be conducted. This study has potential for high public health impact and promise to help improve quality of life for Veterans at high risk for suicide.

Read the detailed description

Despite large-scale, nationwide efforts to better address suicidal behavior (defined as thoughts and behavior) in high-risk Veterans with major depressive disorder (MDD), the development of interventions that target some of the key risk factors associated with suicide in Veterans with MDD remains limited. That is, while much intervention research continues to investigate treatments like cognitive behavioral therapy (CBT) that target behavioral patterns, emotion processing problems, and cognitive styles associated with suicide risk in MDD, deficits in the neurocognitive substrates that underlie these CBT targets remain under-addressed. Cognitive remediation (CR) and rehabilitation have long been a primary treatment for patients with other psychiatric illnesses, like schizophrenia, for improving cognitive functioning and facilitating transfer of cognitive skills to every-day functioning. However, scant work has examined CR that addresses the neurocognitive deficits underlying suicidal behavior in individuals with MDD. Empirical work has identified key executive functioning (EF) deficits that may be specific to MDD patients with suicidal behavior, and meta-analytic work indicates that CR has moderate effect sizes on cognitive functioning, depression, and daily functioning in MDD. Thus, the field is in dire need of work that examines CR as a recovery-oriented treatment approach for MDD patients at risk for suicide.

The proposed study aims to collect pilot data to test the feasibility and acceptability of adjunctive neuroplasticity-based CR on key treatment targets delivered via telehealth during this time of COVID-19 in a sample of 36 Veterans with MDD and a history of suicide attempt(s). Specifically, it will test the effects of an adjunctive evidence-based cognitive remediation (CR) therapy (adjunctive to treatment as usual) augmented with manualized "Bridging" sessions on transfer and practice of cognitive control and decision-making/problem-solving strategies for real-world situations and problems, including those that trigger suicidal thoughts. The investigators propose to administer the Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed CR plus "Bridging" session, CR+Bridging) to a total of 36 Veterans with MDD and a history of suicide attempt(s). The intervention will be delivered in 20 90-minute sessions (2x/week for 10 weeks). Pre-treatment assessments of neurocognitive, clinical, social, and real-world functioning will be conducted, including measures that examine the impact of COVID-19 and its accompanying "social-distancing" restrictions. Posttreatment assessments of the same targets will be conducted to determine clinical response to and feasibility of this therapeutic intervention immediately following conclusion of the intervention (Week 10) and at a follow-up assessment (Week 20). This application is novel in that it constitutes the first implementation of this intervention in Veterans with MDD and suicidal behavior. Consistent with RR\&D's SPiRE mechanism, this study is high risk, but it has high potential impact and promise to help improve quality of life for Veterans at high risk for suicide.

Conditions: Major Depressive Disorder
Being tested: Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed Cognitive Remediation plus Bridging)
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed Cognitive Remediation plus Bridging)Other
Also called Adjunctive Cognitive Remediation
The proposed study aims to collect pilot data to test the feasibility and acceptability of adjunctive neuroplasticity-based cognitive remediation on key treatment targets. The intervention will be delivered via telehealth to a sample of 36 Veterans with MDD and a history of a suicide attempt. The intervention will be delivered in 20 90-min sessions (2x/week for 10 weeks). Pre-, post, and follow-up assessments will be conducted to assess changes in neurocognitive, clinical, social, and real-world functioning.

Study groups in NCT04952532
Study group	Role	What they receive
Cognitive Remediation+Bridging Intervention	Other	This is a pilot study to collect feasibility data on this novel cognitive remediation intervention for Veterans at high risk for suicide. All patients will receive the active intervention. Receives: Other: Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed Cognitive Remediation plus Bridging)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score: Pre- Minus Post-treatment Intervention
The research team will use the Montgomery-Asberg Depression Rating Scale (MADRS) to examine depression symptoms. A higher MADRS score indicates more severe depression and the overall score ranges from 0 to 60. There are 10 items and each item yields a score of 0 to 6. These 10 sub-items are added together for the total score.
Typical cutoff points for the total MADRS score are:
0 to 6 - normal/symptom absent 7 to 19 - mild depression 20-34 - moderate depression >34 - severe depression Note: The investigators will examine the change in MADRS score from pre-treatment to post-treatment intervention. A positive change score means improvement in depression severity from pre- to post-treatment. The investigators hypothesize that there will be positive change scores following this treatment intervention.
Measured: Change in Pre-treatment Score minus Post-treatment Score (Week 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202231 Dec 2024

First posted7 Jul 2021
Study start1 Jan 2022
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Model description: This is a feasibility and acceptability pilot study which aims to collect preliminary data for a future grant application proposing a randomized clinical trial. This pilot study aims to collect feasibility data of this therapeutic intervention in Veterans. The Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed CR pus bridging session) intervention involves 20 90-minute sessions (2x/week for 10 weeks). Pre- and post-treatment assessments of neurocognitive, clinical, social, and real-world functioning will be conducted.
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04952532
Sponsor's protocol ID: D3738-P
Other IDs: 1I21RX003738-01A1
Acronym: CogRemVet
Status last verified: Jan 2026
First submitted: 2 Jul 2021
Last updated: 26 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We will request IRB approval to share deidentified data.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
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RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Novel Cognitive Remediation Intervention Targeting Poor Decision-Making and Depression in Veterans at High Risk for Suicide: A Safe, Telehealth Approach During the COVID-19 Pandemic
ClinicalTrials.gov ID: NCT04952532
Acronym / sponsor ID: CogRemVet / D3738-P
Conditions: Major Depressive Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Jan 2022 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 7 Jul 2021 (actual)
Results: Posted 26 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a feasibility and acceptability pilot study which aims to collect preliminary data for a future grant application proposing a randomized clinical trial. This pilot study aims to collect feasibility data of this therapeutic intervention in Veterans. The Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed CR pus bridging session) intervention involves 20 90-minute sessions (2x/week for 10 weeks). Pre- and post-treatment assessments of neurocognitive, clinical, social, and real-world functioning will be conducted.

Arm	Type	Receives
Cognitive Remediation+Bridging Intervention	Other	Other: Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed Cognitive Remediation plus Bridging)This is a pilot study to collect feasibility data on this novel cognitive remediation intervention for Veterans at high risk for suicide. All patients will receive the active intervention.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

U.S. Veteran;
Primary diagnosis of major depressive disorder (MDD) and a history of suicide attempt in the past year;
Elevated score (>1SD above the normal mean) on rumination measure (Ruminative Response Scale);
Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) current suicidal ideation (either passive, i.e. "wish to be dead") or active ideation but with no intent to act on it immediately and no specific plan;
Currently in psychotherapy treatment as usual (TAU) at the James J. Peters VA Medical Center.

Key exclusion criteria (3 listed)

Current substance use disorder;
History of traumatic brain injury; neurological disorder, or other medical confound; compromised intellectual abilities (WASI45 FSIQ<70)
The investigators will enroll six Veterans in each group and conduct six 10-week intervention cycles for a total sample of 36 Veterans.

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
Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed Cognitive Remediation plus Bridging)Also: Adjunctive Cognitive RemediationThe proposed study aims to collect pilot data to test the feasibility and acceptability of adjunctive neuroplasticity-based cognitive remediation on key treatment targets. The intervention will be delivered via telehealth to a sample of 36 Veterans with MDD and a history of a suicide attempt. The intervention will be delivered in 20 90-min sessions (2x/week for 10 weeks). Pre-, post, and follow-up assessments will be conducted to assess changes in neurocognitive, clinical, social, and real-world functioning.	Other	Cognitive Remediation+Bridging Intervention

Primary outcome

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score: Pre- Minus Post-treatment Intervention
Time frame: Change in Pre-treatment Score minus Post-treatment Score (Week 10)
The research team will use the Montgomery-Asberg Depression Rating Scale (MADRS) to examine depression symptoms. A higher MADRS score indicates more severe depression and the overall score ranges from 0 to 60. There are 10 items and each item yields a score of 0 to 6. These 10 sub-items are added together for the total score. Typical cutoff points for the total MADRS score are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20-34 - moderate depression >34 - severe depression Note: The investigators will examine the change in MADRS score from pre-treatment to post-treatment intervention. A positive change score means improvement in depression severity from pre- to post-treatment. The investigators hypothesize that there will be positive change scores following this treatment intervention.

Results and safety

Results posted to the registry on 26 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitive Remediation+Bridging Intervention	9	9

Primary outcome: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score: Pre- Minus Post-treatment Intervention

Time frame: Change in Pre-treatment Score minus Post-treatment Score (Week 10). Mean (Standard Deviation). Unit: Score on a Scale

Measure	There is Only One Arm in This Acceptability/Feasibility Study and it is the Active Treatment. n = 9
Value	7.1 (1.6)

There is Only One Arm in This Acceptability/Feasibility Study and it is the Active Treatment.: p <0.05, ANOVA

Population analysed: Change in pre-treatment MADRS score minus post-treatment score (Week 10)

Adverse events

Time frame: 20 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cognitive Remediation+Bridging Intervention	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Limitations and caveats (from the sponsor): As is the case with pilot studies, results are preliminary due to the study's small sample size and exploratory nature. Thus, the statistical assumptions for repeated-measures ANOVAs may not have been fully met for all analyses. In addition, this pilot study only included male Veterans which may limit generalizability. This study has a small sample size (n=9), which was powered to detect large magnitude effect size improvements (i.e. Hedges' g \> 1.0).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. We will request IRB approval to share deidentified data.

Related trials for Major Depressive Disorder

RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
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Recruiting
Impact of Psychomotor Therapy on the Quality of Life in Depression
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RecruitingPhase 1
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RecruitingPhase 3
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RecruitingPhase 1/2
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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. This study is not recruiting at the moment.

Erin A Hazlett-Oakes, PhD principal investigator

James J. Peters Veterans Affairs Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 3 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: finished, as of the sponsor's last update on 26 Jan 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?

Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score: Pre- Minus Post-treatment Intervention (time frame: Change in Pre-treatment Score minus Post-treatment Score (Week 10)). 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 NCT04952532.

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 26 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.