RecruitingRecruiting
Cognitive Rehabilitation for Veterans With MDD-related Cognitive Functioning Deficits
NCT06728774 · Portland VA Medical Center
In plain English
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Official title
Cognitive Rehabilitation for Veterans With MDD-related Cognitive Functioning Deficits, w/ Joren Adams
About this study
Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) is a manualized group-based behavioral intervention (8 weeks, 2 hours per week) designed to improve cognitive functioning in Veterans with Major Depressive Disorder (MDD) and cognitive complaints. ME-CCT-MDD is an adaptation of CCT initially developed by clinicians and researchers at the VA Portland Healthcare System and the VA San Diego Healthcare System. CCT draws from the empirical and theoretical literature on compensatory strategy training for conditions characterized by cognitive complaints and impairments, including mild traumatic brain injury, psychosis, and mild cognitive impairment.
ME-CCT-MDD is a comprehensive treatment in that it addresses multiple types of symptoms and concerns that interfere with recovery from depressed mood episodes - cognitive impairments, neuropsychiatric symptoms, and lifestyle patterns that increase the risk of cognitive impairment, poor health, and MDD relapse. In addition to training in compensatory cognitive skills, ME-CCT-MDD includes mindfulness practices and motivational interviewing techniques to boost the adoption of lifestyle strategies (e.g., nutrition, exercise) that improve cognition and overall health. ME-CCT-MDD is designed to be easy to administer and as an adjunct to standard MDD treatment programs.
Given the high rate of MDD among Veterans, the prevalence of cognitive impairments among those with MDD, and the negative impact of cognitive impairments on vocational functioning, psychosocial functioning, quality of life, and treatment outcomes, an evidence-based cognitive training intervention that optimally addresses the complex needs of Veterans with MDD and cognitive impairments is of critical importance. This study will allow the investigators to assess the feasibility and acceptability of the ME-CCT-MDD intervention in preparation for a larger-scale pilot randomized control trial.
Eligibility criteria
Inclusion Criteria:
1. Veterans 18 years of age or older
2. Self-reported concerns about cognitive functioning deficits or clinical concerns about cognitive functioning deficits documented in EHR
3. meets DSM-5 criteria for MDD and receiving treatment for this diagnosis at the Portland VA within the past year
4. moderate or greater depressive symptoms as assessed by a PHQ-9 score ≥ 10
5. current cognitive functioning deficits as determined by performance on at least two measures in one cognitive domain (i.e., memory, attention/processing speed, language, executive functioning) falling ≥1 SD below their age-appropriate norms in the absence of memory impairment.
Exclusion Criteria:
1. impaired capacity to understand study risks and benefits
2. history of TBI as defined by American College of Rehabilitation Medicine and VA/DoD criteria
3. meets DSM-5 criteria for a substance use disorder other than nicotine use disorder in the past 6 months
4. meets DSM-5 criteria for dementia, psychotic disorder, or "with psychotic features" specifier
5. active suicidal intent with significant clinical risk
6. auditory or visual impairments that would prevent ability to participate in cognitive rehabilitation group or assessments. Eligibility will be established by electronic medical record review conducted by study staff and will be confirmed by the Veteran during the initial phone call.
Study design
Enrollment target: 24 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-05-01
Estimated completion: 2026-06
Last updated: 2025-06-06
Interventions
Behavioral: Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD)Behavioral: Goal-focused Supportive Contact
Primary outcomes
- • Recruitment Rate (From enrollment to the end of treatment at 8 weeks)
- • Study Retention (From enrollment to the second assessment (within 2 weeks post-treatment))
- • Rate of Intervention Completion (From enrollment to the end of treatment at 8 weeks)
Sponsor
Portland VA Medical Center · fed
With: Oregon Health and Science University
Contacts & investigators
ContactJoren Adams · contact · joren.adams@va.gov · 503-220-8262
InvestigatorMaya O'Neil, PhD · principal_investigator, Portland VA Medical Center
InvestigatorJoren Adams · principal_investigator, Portland VA Medical Center
All locations (1)
Portland VA Medical CenterRecruiting
Portland, Oregon, United States