Recruiting

ME-CCT-MDD & GSC

Sponsor:

Portland VA Medical Center

Code:

NCT06728774

Conditions

Major Depressive Disorder (MDD)

Cognitive Dysfunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Goal-focused Supportive Contact

Study Details

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.

Conditions

Major Depressive Disorder (MDD)

Cognitive Dysfunction

Study ID

NCT06728774

Start date

May 1, 2025

Status verified date

Jun, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder

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.

active comparator: Goal-focused Supportive Contact

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.

Interventions

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

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 Contact

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.

Primary outcome measure

  • Recruitment Rate [ Time Frame: From enrollment to the end of treatment at 8 weeks ]
  • Study Retention [ Time Frame: From enrollment to the second assessment (within 2 weeks post-treatment) ]
  • Rate of Intervention Completion [ Time Frame: From enrollment to the end of treatment at 8 weeks ]
  • Feasibility of Testing Procedures [ Time Frame: From enrollment to the second assessment (within 2 weeks post-treatment) ]
  • Feasibility of data collection methods [ Time Frame: From enrollment to the second assessment (within 2 weeks post-treatment) ]
  • Acceptability, by participant report [ Time Frame: From enrollment to the second assessment (within 2 weeks post-treatment) ]

Central Contacts and Locations

Central contacts

Joren Adams

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

Locations

Portland VA Medical Center

Recruiting

Portland, Oregon, United States, 97239

Contacts

Joren Adams

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

More Information

Sponsor

Portland VA Medical Center

Last update posted

Jun 6, 2025

Last verified

Jun, 2025

Keywords

  • Veterans
  • Cognitive Rehabilitation
  • Group Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Portland VA Medical Center on 2025-06-06.