Cognitive Rehabilitation for Veterans With MDD-related Cognitive Functioning Deficits

NCT06728774 | Recruiting

• 1 other identifier: 6316
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Major Depressive Disorder (MDD); Cognitive Dysfunction

Keywords

Veterans; Cognitive Rehabilitation; Group Intervention

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  From enrollment to the second assessment (within 2 weeks post-treatment)

• Rate of Intervention Completion

  Percentage of participants that complete the 8-week intervention.

  From enrollment to the end of treatment at 8 weeks

• Feasibility of Testing Procedures

  Percentage of participants where follow-up visit was completed.

  From enrollment to the second assessment (within 2 weeks post-treatment)

• Feasibility of data collection methods

  Percentage of participants with complete data sets.

  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).

  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)

  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)

  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)

  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)

  From enrollment to the second assessment (within 2 weeks post-treatment)

• Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Coding

  From enrollment to the second assessment (within 2 weeks post-treatment)

Study Arms (2)

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.

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.

Behavioral: Goal-focused Supportive Contact

Interventions

Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) BEHAVIORAL

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.

Also known as: Compensatory Cognitive Training

Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder

Goal-focused Supportive Contact BEHAVIORAL

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.

Goal-focused Supportive Contact

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Portland VA Medical Center: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

Portland VA Medical Center

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Maya O'Neil, PhD

  Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

• Joren Adams

  Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joren Adams

CONTACT

503-220-8262; joren.adams@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Researcher

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: December 11, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)