Clinical trial NCT06728774: Cognitive Rehabilitation for Veterans With MDD-related Cognitive Functioning Deficits
Official title: Cognitive Rehabilitation for Veterans With MDD-related Cognitive Functioning Deficits, w/ Joren Adams
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Cognitive Dysfunction
Keywords: Veterans
Cognitive Rehabilitation
Group Intervention
Lead sponsor: Portland VA Medical Center
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2024-12-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Individuals with depression often describe difficulties with memory, attention, concentration, and overall cognitive functioning, which can persist even after mood episodes get better, and can affect treatment and health outcomes.

The primary objective of this pilot clinical trial is to evaluate the feasibility and acceptability of a manualized, 8-week, Compensatory Cognitive Training (CCT) intervention for Veterans who received treatment for MDD in the past year and have persistent cognitive functioning deficits. The investigators will compare Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) to a robust comparator, Goal-focused Supportive Contact (GSC), to evaluate differences in outcome measures.

The investigators hypothesize that Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) will be feasible and acceptable to participants in a pilot trial of ME-CCT-MDD vs. Goal-focused supportive contact (GSC) for Veterans with recent MDD treatment and persistent cognitive symptoms.

This study will also evaluate the preliminary magnitude and direction of symptom change on measures of objective cognitive functioning, psychiatric symptomatology, psychosocial functioning, and quality of life.

The investigators hypothesize that CCT will improve objective cognitive functioning, psychiatric outcomes, psychosocial functioning, and quality of life in Veterans with recent MDD-related cognitive functioning deficits.

Participants who agree to participate in the study will:

1. Take part in an assessment of their cognition, symptoms, and functioning, which will take approximately 2 hours. The assessment will include an interview about their medical, psychiatric, and cognitive history. It will also include questionnaires about their symptoms and daily functioning as well as neuropsychological tests, which are paper-pencil tests that evaluate aspects of cognition such as memory, attention, and problem-solving skills.
2. Be randomly assigned (like the flip of a coin) to receive Goal-Focused Supportive Contact or Compensatory Cognitive Training. Both treatments will involve weekly groups with a mental health provider for approximately 2 hours per week for 8 weeks. Goal-Focused Treatment includes setting and achieving short-term and long-term goals for improving cognition and functioning. Compensatory Cognitive Training includes training in strategies to improve cognition and manage stress.
3. Complete a follow-up assessment of cognition, symptoms, and functioning 8 weeks after they begin treatment, as well as a brief interview about their experience in the group. These assessment sessions will take approximately 2 hours.

Detailed description: 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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Study Retention
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Rate of Intervention Completion
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Feasibility of Testing Procedures
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Feasibility of data collection methods
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Acceptability, by participant report
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
Secondary outcomes:
measure: Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Overall)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Digit Span Forward)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Digit Span Backward)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Digit Span Sequencing)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Coding
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Symbol Search
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Trials 1-5 Correct)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Delayed Recall Correct)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Total Recall Correct)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Short Delay Free Recall)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Short Delay Cued Recall)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Long Delay Free Recall)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Long Delay Cued Recall)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Recognition Discriminability)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: BVMT-R (Total Recall)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: BVMT-R (Delayed Recall)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: D-KEFS Verbal Fluency Test (Letter Fluency Total Correct)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: D-KEFS Verbal Fluency Test (Category Fluency Total Correct)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: D-KEFS Verbal Fluency Test (Category Switching Total Correct)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: D-KEFS Verbal Fluency Test (Category Switching Total Switching Accuracy)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Visual Scanning)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Number Sequencing)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Letter Sequencing)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Number-Letter Switching)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Motor Speed)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Self-Report Measures, Pre-Post Symptom Change
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Self-Report Measures, Pre-Post Symptom Change: PHQ-9
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Self-Report Measures, Pre-Post Symptom Change: WHODAS 2.0 (General Disability Score)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Self-Report Measures, Pre-Post Symptom Change: Prospective-Retrospective Memory Questionnaire (PRMQ)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Self-Report Measures, Pre-Post Symptom Change: Neuro-QoL (Cognition Subscale)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Self-Report Measures, Pre-Post Symptom Change: Neuro-QoL (Ability to Participate in Social Roles and Activities Subscale)
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
measure: Self-Report Measures, Pre-Post Symptom Change: PCSS
timeFrame: From enrollment to the second assessment (within 2 weeks post-treatment)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
Study officials:
affiliation: Portland VA Medical Center
name: Maya O'Neil, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Portland VA Medical Center
name: Joren Adams
role: PRINCIPAL_INVESTIGATOR
References: