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

Part of paid clinical trials in The Bronx, New York.

Sponsor
VA Office of Research and Development
Study ID
NCT04952532
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jan 1, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Cognitive Remediation+Bridging Intervention
    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.

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters VA Medical Center, Bronx, NYThe BronxNew York10468-3904-

Find similar trials in The Bronx, NY

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
James J. Peters VA Medical Center, Bronx, NY· The Bronx, NY

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