Cognitive Rehabilitation for Veterans With MDD-related Cognitive Functioning Deficits

Официальное название

Cognitive Rehabilitation for Veterans With MDD-related Cognitive Functioning Deficits, w/ Joren Adams

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Digit Span Subtest (Overall) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: From enrollment to the second assessment (within 2 weeks post-treatment)]
• Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Coding [Срок оценки: From enrollment to the second assessment (within 2 weeks post-treatment)]
• Objective Cognitive Functioning, Pre-Post Change: WAIS-IV Symbol Search [Срок оценки: From enrollment to the second assessment (within 2 weeks post-treatment)]
• Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Trials 1-5 Correct) [Срок оценки: From enrollment to the second assessment (within 2 weeks post-treatment)]
• Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Delayed Recall Correct) [Срок оценки: From enrollment to the second assessment (within 2 weeks post-treatment)]
• Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Total Recall Correct) [Срок оценки: From enrollment to the second assessment (within 2 weeks post-treatment)]
• Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Short Delay Free Recall) [Срок оценки: From enrollment to the second assessment (within 2 weeks post-treatment)]
• Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Short Delay Cued Recall) [Срок оценки: From enrollment to the second assessment (within 2 weeks post-treatment)]
• Objective Cognitive Functioning, Pre-Post Change: CVLT-3 (Long Delay Free Recall) [Срок оценки: From enrollment to the second assessment (within 2 weeks post-treatment)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Portland VA Medical Center — Portland

Идентификаторы

NCT: NCT06728774 · 6316

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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