Cognitive Rehabilitation for Depression

Overseen By Joren Adams

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Portland VA Medical Center

Disqualifiers: TBI, Substance use, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

24 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study staff or your healthcare provider.

What data supports the effectiveness of the treatment Goal-focused Supportive Contact, Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD)?

Research shows that cognitive training can significantly improve cognitive and emotional outcomes in people with major depressive disorder, suggesting it could be a valuable treatment option. Additionally, online working memory training has shown lasting improvements in self-reported cognitive functioning, indicating potential benefits for similar cognitive rehabilitation approaches. ^{1 2 3 4 5}

Is cognitive rehabilitation for depression safe for humans?

Computerized cognitive training (CCT), a form of cognitive rehabilitation, is generally considered safe and has been used in various clinical populations, including those with depression, without significant safety concerns reported. ^{3 6 7 8 9}

How is the treatment ME-CCT-MDD different from other treatments for depression?

ME-CCT-MDD is unique because it combines motivational support with cognitive training to specifically target cognitive impairments in depression, which are often not addressed by standard treatments. This approach aims to improve both cognitive and emotional symptoms, offering a novel way to enhance overall functioning in individuals with major depressive disorder. ^{1 3 6 8 10}

What is the purpose of this trial?

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.

Research Team

Maya O'Neil, PhD

Principal Investigator

Portland VA Medical Center

Joren Adams

Principal Investigator

Portland VA Medical Center

Eligibility Criteria

This trial is for Veterans who have been treated for Major Depressive Disorder (MDD) within the past year and are still struggling with cognitive issues like memory and concentration. Participants must be willing to undergo assessments, attend weekly group sessions for 8 weeks, and complete follow-up evaluations.

Inclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo an assessment of cognition, symptoms, and functioning, including interviews and neuropsychological tests

1 day

1 visit (in-person)

Treatment

Participants receive either ME-CCT-MDD or GSC intervention, involving weekly group sessions for cognitive training or supportive contact

8 weeks

8 visits (in-person)

Follow-up

Participants complete a follow-up assessment of cognition, symptoms, and functioning, including a brief interview about their experience

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Goal-focused Supportive Contact
• Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD)

Trial Overview The study tests an 8-week program called Motivationally Enhanced Compensatory Cognitive Training (ME-CCT-MDD) against Goal-focused Supportive Contact (GSC). It aims to see if ME-CCT-MDD can improve thinking skills, mental health symptoms, daily functioning, and quality of life in Veterans with MDD-related cognitive deficits.

Participant Groups

Group I: Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder Experimental Treatment 1 Intervention

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.

Group II: Goal-focused Supportive Contact Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Portland VA Medical Center

Lead Sponsor

Trials

44

Recruited

7,800+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Findings from Research

This study aims to systematically review and analyze the efficacy of computerized cognitive training (CCT) in improving cognitive performance in adults with depression, focusing on randomized controlled trials.

The research will explore how CCT affects not only cognitive outcomes but also mood and daily functioning, making it the first comprehensive analysis of its kind in this specific clinical population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis. Lampit, A., Launder, NH., Minkov, R., et al.[2022]

Computerized cognitive training (CCT) using Brain HQ showed significant cognitive improvements in psychiatric rehabilitation clients, with an average increase of 4.4 points in BACS t-scores after about 17 days of training.

Higher engagement in training (measured by levels completed per day) was positively correlated with cognitive gains, suggesting that monitoring engagement can help identify patients who may need additional support to benefit from CCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training engagement, baseline cognitive functioning, and cognitive gains with computerized cognitive training: A cross-diagnostic study. Harvey, PD., Balzer, AM., Kotwicki, RJ.[2020]

In a study involving 46 young adults with mild depressive symptoms, executive functioning and processing speed (EF/PS)-focused computerized cognitive training (CCT) led to greater improvements in those specific cognitive areas compared to verbal ability-focused CCT.

Both types of CCT resulted in significant improvements in mood and everyday functioning, but the EF/PS group achieved similar mood benefits with only half the training time, suggesting that the content of CCT may not be as crucial as the engagement in the training itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in young adults with depressive symptoms: Effects on mood, cognition, and everyday functioning. Motter, JN., Grinberg, A., Lieberman, DH., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of Cognitive Training in Adults with Major Depressive Disorder. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive dysfunction in major depression: From assessment to novel therapies. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Improvement in self-reported cognitive functioning but not in rumination following online working memory training in a two-year follow-up study of remitted major depressive disorder. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Enhancing memory in late-life depression: the effects of a combined psychoeducation and cognitive training program. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Predictors of Long-Term Improvement Following Cognitive Remediation in a Sample With Elevated Depressive Symptoms. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Systematic review of randomized controlled trials of candidate treatments for cognitive impairment in depression and methodological challenges in the field. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Training engagement, baseline cognitive functioning, and cognitive gains with computerized cognitive training: A cross-diagnostic study. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in young adults with depressive symptoms: Effects on mood, cognition, and everyday functioning. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Computerized Working Memory Training in Remission From Major Depressive Disorder: Effects on Emotional Working Memory, Processing Speed, Executive Functions, and Associations With Symptoms. [2023]