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

NCT04952532 | Completed Results DMC

• 2 other identifiers: D3738-P1I21RX003738-01A1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in Pre-treatment Score minus Post-treatment Score (Week 10)

Study Arms (1)

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.

Other: Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed Cognitive Remediation plus Bridging)

Interventions

Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed Cognitive Remediation plus Bridging) OTHER

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.

Also known as: Adjunctive Cognitive Remediation

Cognitive Remediation+Bridging Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

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).

Results Point of Contact

• Title: Erin A. Hazlett, PhD, Senior VA Research Career Scientist
• Organization: James J. Peters VAMC, Bronx, NY, 130 W. Kingsbridge Rd, Bronx, NY 10468

erin.hazlett-oakes@va.gov

718-584-9000

Study Officials

• Erin A Hazlett-Oakes, PhD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label pilot study. The clinician conducting the clinical assessments will be blind to how the participants are doing in the treatment intervention. i.e. one clinician will administer the treatment and another will do the outcome assessment.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 7, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Once the study is completed we will share the supporting information.
• Access Criteria: Once the study is completed and data are analyzed and submitted for publication, we will share the deidentified data.

Locations

US (1)