Cognitive Remediation Therapy for Depression

(CogRemVet Trial)

Overseen By Erin A Hazlett-Oakes, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use disorder, Traumatic brain injury, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 10 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment combining cognitive exercises and practical sessions for Veterans with depression and past suicide attempts. The goal is to improve thinking skills to better handle stress and reduce suicidal thoughts.

Research Team

Erin A Hazlett-Oakes, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Eligibility Criteria

This trial is for U.S. Veterans aged 18-60 with major depressive disorder and a history of suicide attempts within the past year. They must have current suicidal thoughts without immediate plans to act on them, be in ongoing psychotherapy, and score high on rumination measures. Women are encouraged to participate, aiming for at least 30% female participants.

Inclusion Criteria

You are a military veteran from the United States.

You have a high score on a test that measures how much you think about the same things over and over.

You must be between 18 and 60 years old.

Exclusion Criteria

You have had a head injury in the past.

You have serious difficulty with thinking and understanding things.

You currently have a problem with using drugs or alcohol.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 10-week (20 session) cognitive remediation intervention via telehealth

10 weeks

20 sessions (virtual)

Post-treatment Assessment

Post-treatment assessments of neurocognitive, clinical, social, and real-world functioning are conducted

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

Treatment Details

Interventions

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

Trial Overview The study tests a new cognitive therapy called NEAR (Cognitive Remediation plus Bridging) delivered via telehealth over 10 weeks with 20 sessions. It's designed to help veterans improve decision-making and manage stressors that could lead to suicidal thoughts by practicing problem-solving strategies.

Participant Groups

Group I: Cognitive Remediation+Bridging Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+