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 Clinical Trial

— CogRemVet  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04952532
• Other study ID #: D3738-P
• Secondary ID: 1I21RX003738-01A
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: Erin A Hazlett-Oakes, PhD
• Phone: (718) 584-9000
• Email: Erin.Hazlett-Oakes[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18-60;

• 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.

Related Conditions & MeSH terms

• COVID-19
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Suicide

Intervention

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

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: We 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. We hypothesize that there will be positive change scores following this treatment intervention.	Change in Pre-treatment Score minus Post-treatment Score (Week 10)