Major Depressive Disorder (MDD)NCT06728774
Cognitive Rehabilitation for Veterans With MDD-related Cognitive Functioning Deficits
A study testing Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) and Goal-focused Supportive Contact in people with Major Depressive Disorder (MDD) and Cognitive Dysfunction, run by Portland VA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD), Cognitive Dysfunction
- What is being tested?
- Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) and Goal-focused Supportive Contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans 18 years of age or older
- Self-reported concerns about cognitive functioning deficits or clinical concerns about cognitive functioning deficits documented in EHR
- meets DSM-5 criteria for MDD and receiving treatment for this diagnosis at the Portland VA within the past year
- moderate or greater depressive symptoms as assessed by a PHQ-9 score ≥ 10
- 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.
Who cannot join
- impaired capacity to understand study risks and benefits
- history of TBI as defined by American College of Rehabilitation Medicine and VA/DoD criteria
- meets DSM-5 criteria for a substance use disorder other than nicotine use disorder in the past 6 months
- meets DSM-5 criteria for dementia, psychotic disorder, or "with psychotic features" specifier
- active suicidal intent with significant clinical risk
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Portland VA Medical Center
Portland, Oregon, 97239
Joren Adams, 503-220-8262 ext. 52825, joren.adams@va.gov
About this study
Official title: Cognitive Rehabilitation for Veterans With MDD-related Cognitive Functioning Deficits, w/ Joren Adams
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.
Read more
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:
- 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.
- 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.
- 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.
Read the 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.
- Being tested
- Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD), Goal-focused Supportive Contact
- Keywords
- Veterans, Cognitive Rehabilitation, Group Intervention
- Medical subject headings
- Depressive Disorder, Major, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD)Behavioural
Also called Compensatory Cognitive Training
8-week manualized group-based behavioral intervention including compensatory cognitive training for difficulties with learning, memory, processing speed, executive functioning, verbal functioning, concentration, and attention.
Goal-focused Supportive ContactBehavioural
8-week group-based behavioral intervention primarily focused on setting and achieving short or long-term goals. Does not provide training in cognitive strategies, lifestyle strategies, or motivational enhancement.
| Study group | Role | What they receive |
|---|---|---|
| Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder | Experimental | Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) is a manualized group-based behavioral intervention (8 weeks, 2 hour per week) designed to improve cognitive functioning in Veterans with Major Depressive Disorder (MDD) and cognitive complaints. Receives: Behavioral: Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) |
| Goal-focused Supportive Contact | Active comparator | Goal-focused Supportive Contact (GSC) is a group therapy intervention that provides the same frequency (8 weeks , 2 hours per week) and amount of therapist and other group member contact as ME-CCT-MDD. Receives: Behavioral: Goal-focused Supportive Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants included from eligible Veterans; Recruitment will be deemed feasible if investigators successfully screen 50% of Veterans referred to the study for eligibility and enroll 75% of screened Veterans who meet all study inclusion criteria.
Measured: From enrollment to the end of treatment at 8 weeks
Study Retention
Retention will be deemed successful if the investigators achieve 80% completion for post-treatment assessments.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Rate of Intervention Completion
Percentage of participants that complete the 8-week intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Feasibility of Testing Procedures
Percentage of participants where follow-up visit was completed.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Feasibility of data collection methods
Percentage of participants with complete data sets.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Acceptability, by participant report
Treatment will be deemed acceptable if ≥ 70% of Veterans score ≥ 12 on the Acceptability of Intervention Measure (AIM).
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Secondary outcomes (32)
Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Overall)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV): Digit Span Subtest (Overall).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation=3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Digit Span Forward)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV): Digit Span Subtest (Digit Span Forward).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation=3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Digit Span Backward)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV): Digit Span Subtest (Digit Span Backward).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation=3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Digit Span Sequencing)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV): Digit Span Subtest (Digit Span Sequencing).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation=3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Coding
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV): Coding.
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation=3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Symbol Search
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV): Symbol Search.
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation=3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Trials 1-5 Correct)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the California Verbal Learning Test - Third Edition (CVLT-3): Trials 1-5 Correct.
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Standard Score (StdS) using age-adjusted normative samples. StdS ranges from 40 to 160 (Mean=100, Standard Deviation=15) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Delayed Recall Correct)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the California Verbal Learning Test - Third Edition (CVLT-3): Delayed Recall Correct.
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Standard Score (StdS) using age-adjusted normative samples. StdS ranges from 40 to 160 (Mean=100, Standard Deviation=15) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Total Recall Correct)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the California Verbal Learning Test - Third Edition (CVLT-3): Total Recall Correct.
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Standard Score (StdS) using age-adjusted normative samples. StdS ranges from 40 to 160 (Mean=100, Standard Deviation=15) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Short Delay Free Recall)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the California Verbal Learning Test - Third Edition (CVLT-3): Short Delay Free Recall.
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Short Delay Cued Recall)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the California Verbal Learning Test - Third Edition (CVLT-3): Short Delay Cued Recall.
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Long Delay Free Recall)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the California Verbal Learning Test - Third Edition (CVLT-3): Long Delay Free Recall.
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. StdS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Long Delay Cued Recall)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the California Verbal Learning Test - Third Edition (CVLT-3): Long Delay Cued Recall.
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Recognition Discriminability)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the California Verbal Learning Test - Third Edition (CVLT-3): Recognition Discriminability.
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: BVMT-R (Total Recall)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Brief Visuospatial Memory Test - Revised (BVMTR): Total Recall.
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a T-Score using age-adjusted normative samples. T-Scores range from 20 to 80 (Mean=50, Standard Deviation= 10) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: BVMT-R (Delayed Recall)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Brief Visuospatial Memory Test - Revised (BVMTR): Delayed Recall.
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a T-Score using age-adjusted normative samples. T-Scores range from 20 to 80 (Mean=50, Standard Deviation= 10) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Verbal Fluency Test (Letter Fluency Total Correct)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Delis-Kaplan Executive Functioning System (D-KEFS): Verbal Fluency Test (Letter Fluency Total Correct).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Verbal Fluency Test (Category Fluency Total Correct)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Delis-Kaplan Executive Functioning System (D-KEFS): Verbal Fluency Test (Category Fluency Total Correct).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Verbal Fluency Test (Category Switching Total Correct)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Delis-Kaplan Executive Functioning System (D-KEFS): Verbal Fluency Test (Category Switching Total Correct).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Verbal Fluency Test (Category Switching Total Switching Accuracy)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Delis-Kaplan Executive Functioning System (D-KEFS): Verbal Fluency Test (Category Switching Total Switching Accuracy).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Visual Scanning)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Delis-Kaplan Executive Functioning System (D-KEFS): Trail Making Test (Visual Scanning).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Number Sequencing)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Delis-Kaplan Executive Functioning System (D-KEFS): Trail Making Test (Number Sequencing).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Letter Sequencing)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Delis-Kaplan Executive Functioning System (D-KEFS): Trail Making Test (Letter Sequencing).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Number-Letter Switching)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Delis-Kaplan Executive Functioning System (D-KEFS): Trail Making Test (Number-Letter Switching).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Motor Speed)
Magnitude and direction of symptom change will be assessed using paired sample t-tests to assess pre-post differences in neuropsychological testing performance on the Delis-Kaplan Executive Functioning System (D-KEFS): Trail Making Test (Motor Speed).
Per best neuropsychological testing practices, and standardized scoring procedures, participants' raw test scores are converted to a Scaled Score (SS) using age-adjusted normative samples. SS ranges from 1 to 19 (Mean=10, Standard Deviation= 3) with higher scores indicating stronger relative performance.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change
Self-Reported Psychiatric and Cognitive Symptomatology, Psychosocial Functioning, and Quality of Life; Pre-Post Symptom Change Magnitude and direction of symptom change will be assessed by examining pre-post differences on self-report measures.
Questionnaire Battery Includes: Patient Health Questionnaire (PHQ-9), WHO Disability Assessment Schedule (WHODAS 2.0), Prospective-Retrospective Memory Questionnaire (PRMQ), Neuro-QOL: Cognition \& Ability to Participate in Social Roles and Activities, Portland Cognitive Strategies Scale 2.0 (PCSS).
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change: PHQ-9
Magnitude and direction of symptom change will be assessed using paired sample t-tests for evaluating pre-post differences in self-reported symptomatology on the Patient Health Questionnaire-9 (PHQ-9).
Scores range from 0 to 27, with higher scores indicating greater symptom severity.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change: WHODAS 2.0 (General Disability Score)
Magnitude and direction of symptom change will be assessed using paired sample t-tests for evaluating pre-post differences in self-reported symptomatology on the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0): General Disability Score.
Scores range from 36 to 180, with higher scores indicating greater symptom severity.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change: Prospective-Retrospective Memory Questionnaire (PRMQ)
Magnitude and direction of symptom change will be assessed using paired sample t-tests for evaluating pre-post differences in self-reported symptomatology on the Prospective-Retrospective Memory Questionnaire (PRMQ).
Scores range from 16 to 80, with higher scores indicating greater symptom severity.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change: Neuro-QoL (Cognition Subscale)
Magnitude and direction of symptom change will be assessed using paired sample t-tests for evaluating pre-post differences in self-reported symptomatology on the Quality of Life in Neurological Disorder (Neuro-QOL): Cognition Subscale
Scores range from 28 to 140, with higher scores indicating greater functional ability.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change: Neuro-QoL (Ability to Participate in Social Roles and Activities Subscale)
Magnitude and direction of symptom change will be assessed using paired sample t-tests for evaluating pre-post differences in self-reported symptomatology on the Quality of Life in Neurological Disorder (Neuro-QOL): Ability to Participate in Social Roles and Activities.
Scores range from 8 to 40, with higher scores indicating greater functional ability.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change: PCSS
Magnitude and direction of symptom change will be assessed using paired sample t-tests for evaluating pre-post differences in self-reported symptomatology on the Portland Cognitive Strategies Scale 2.0 (PCSS).
Scores range from 0 to 60, with higher scores indicating greater cognitive strategy usage.
Measured: From enrollment to the second assessment (within 2 weeks post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 May 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portland VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Joren Adams, Portland VA Medical Center
- Investigators
- Maya O'Neil, PhD, Principal investigator, Portland VA Medical CenterJoren Adams, Principal investigator, Portland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728774
- Sponsor's protocol ID
- 6316
- Status last verified
- Jun 2025
- First submitted
- 18 Nov 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation for Veterans With MDD-related Cognitive Functioning Deficits, w/ Joren Adams
- ClinicalTrials.gov ID
- NCT06728774
- Acronym / sponsor ID
- 6316
- Keywords
- Veterans, Cognitive Rehabilitation, Group Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Portland VA Medical CenterUS federal agency
- Collaborators
- Oregon Health and Science University
- Study start
- 1 May 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder | Experimental | Behavioral: Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD)Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) is a manualized group-based behavioral intervention (8 weeks, 2 hour per week) designed to improve cognitive functioning in Veterans with Major Depressive Disorder (MDD) and cognitive complaints. |
| Goal-focused Supportive Contact | Active comparator | Behavioral: Goal-focused Supportive ContactGoal-focused Supportive Contact (GSC) is a group therapy intervention that provides the same frequency (8 weeks , 2 hours per week) and amount of therapist and other group member contact as ME-CCT-MDD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veterans 18 years of age or older
- Self-reported concerns about cognitive functioning deficits or clinical concerns about cognitive functioning deficits documented in EHR
- meets DSM-5 criteria for MDD and receiving treatment for this diagnosis at the Portland VA within the past year
- moderate or greater depressive symptoms as assessed by a PHQ-9 score ≥ 10
- 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.
Key exclusion criteria (6 listed)
- impaired capacity to understand study risks and benefits
- history of TBI as defined by American College of Rehabilitation Medicine and VA/DoD criteria
- meets DSM-5 criteria for a substance use disorder other than nicotine use disorder in the past 6 months
- meets DSM-5 criteria for dementia, psychotic disorder, or "with psychotic features" specifier
- active suicidal intent with significant clinical risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD)Also: Compensatory Cognitive Training8-week manualized group-based behavioral intervention including compensatory cognitive training for difficulties with learning, memory, processing speed, executive functioning, verbal functioning, concentration, and attention. | Behavioural | Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder |
| Goal-focused Supportive Contact8-week group-based behavioral intervention primarily focused on setting and achieving short or long-term goals. Does not provide training in cognitive strategies, lifestyle strategies, or motivational enhancement. | Behavioural | Goal-focused Supportive Contact |
Primary outcome
Recruitment Rate
Time frame: From enrollment to the end of treatment at 8 weeks
Number of participants included from eligible Veterans; Recruitment will be deemed feasible if investigators successfully screen 50% of Veterans referred to the study for eligibility and enroll 75% of screened Veterans who meet all study inclusion criteria.
Study Retention
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Retention will be deemed successful if the investigators achieve 80% completion for post-treatment assessments.
Rate of Intervention Completion
Time frame: From enrollment to the end of treatment at 8 weeks
Percentage of participants that complete the 8-week intervention.
Feasibility of Testing Procedures
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Percentage of participants where follow-up visit was completed.
Feasibility of data collection methods
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Percentage of participants with complete data sets.
Acceptability, by participant report
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Treatment will be deemed acceptable if ≥ 70% of Veterans score ≥ 12 on the Acceptability of Intervention Measure (AIM).
32 secondary outcomes
Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Overall)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Digit Span Forward)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Digit Span Backward)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Digit Span Sequencing)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Coding
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Symbol Search
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Trials 1-5 Correct)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Delayed Recall Correct)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Total Recall Correct)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Short Delay Free Recall)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Short Delay Cued Recall)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Long Delay Free Recall)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Long Delay Cued Recall)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Recognition Discriminability)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: BVMT-R (Total Recall)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: BVMT-R (Delayed Recall)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Verbal Fluency Test (Letter Fluency Total Correct)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Verbal Fluency Test (Category Fluency Total Correct)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Verbal Fluency Test (Category Switching Total Correct)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Verbal Fluency Test (Category Switching Total Switching Accuracy)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Visual Scanning)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Number Sequencing)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Letter Sequencing)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Number-Letter Switching)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Objective Cognitive Functioning, Pre-Post Change: D-KEFS Trail Making Test (Motor Speed)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change: PHQ-9
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change: WHODAS 2.0 (General Disability Score)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change: Prospective-Retrospective Memory Questionnaire (PRMQ)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change: Neuro-QoL (Cognition Subscale)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change: Neuro-QoL (Ability to Participate in Social Roles and Activities Subscale)
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Self-Report Measures, Pre-Post Symptom Change: PCSS
Time frame: From enrollment to the second assessment (within 2 weeks post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maya O'Neil, PhD principal investigator
Portland VA Medical Center
Joren Adams principal investigator
Portland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) and Goal-focused Supportive Contact in people with Major Depressive Disorder (MDD) and Cognitive Dysfunction, run by Portland VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joren Adams (503-220-8262 ext. 52825, joren.adams@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.