N/A
N=9
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
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04952532 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score: Pre- Minus Post-treatment Intervention — 7.1 Score on a Scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed Cognitive Remediation plus Bridging) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score: Pre- Minus Post-treatment Intervention |
7.1 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04952532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.