A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD

Официальное название

PATH-Pain: A Primary Care-Based Psychosocial Intervention To Improve Cognitive and Depression Outcomes in Older Adults With MCI and Early Stage AD

Обзор

The purpose of the study is to examine the effect of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive functioning, depression and pain-related disability in 100 older adults with cognitive impairment, chronic pain, and depression. The study will test if PATH-Pain has better cognitive, affective, and functional outcomes than Attention Control Usual Care.

Подробное описание

This is a Randomized Control Trial to target cognition in older adults with MCI or Early AD, depression, and chronic pain with a psychotherapeutic intervention in primary care. This project will study the efficacy of 8 in-office acute treatment sessions (first 8 weeks) and 6 telephone delivered sessions (3 individual and 3 group) in the following months (from 9-36 weeks) of PATH- Pain vs. an equal number of sessions consisting of Attention Control Usual Care in improving cognitive, affective, and functional outcomes. Each therapy session will last approximately 50 minutes. Assessments will be conducted at study entry and weeks 5, 9 (end of acute treatment; includes assessment of cognitive functioning), 24, 36 (end of follow-up treatment; includes assessment of cognitive functioning) and 52 (includes assessments of cognitive functioning) after randomization. This is an efficacy trial, but by being delivered by certified mental health clinicians, it has a strong "real-world" focus.

Вмешательства

• Поведенческое PATH-Pain
  The goals of PATH-Pain are to: 1) Teach problem solving skills to reduce negative emotions, by using emotion regulation and problem- solving strategies to overcome these difficulties. 2) Use compensatory strategies and environmental adaptation tools (notes, checklists, calendars, etc.) to avoid limitations resulting from memory problems, help improve emotion regulation, and create an easier environment to live in. If found helpful and participant agrees, a tablet application called WellPATH will

Первичные конечные точки

• Change in cognitive functioning, as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Срок оценки: Baseline, Weeks 9, 36, 52]

Вторичные конечные точки (3)

• Change in cognition, as measured by the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG) [Срок оценки: Baseline, Weeks 9, 36, 52]
• Change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: Baseline, Weeks 5, 9, 24, 36, 52]
• Change in pain-related disability, as measured by the Roland-Morris Scale [Срок оценки: Baseline, Weeks 5, 9, 24, 36, 52]

Критерии участия

Критерии включения

• Age ≥ 60 years old
• MCI or early stage probable or possible AD diagnosis (as defined by Albert et al or McKhann et al) al). Patients will have at least mild cognitive deficits defined by 16 ≤ MoCA ≤ 25.
• Montgomery Asberg Depression Rating Scale (MADRS)\[55\] total ≥ 5, which reflects at least some mild depressive symptoms.
• Participants will be off antidepressants, cholinesterase inhibitors or memantine or on a stable dosage for at least 12 weeks.
• Chronic pain (neuropathic, nociceptive or mixed disorders): presence of pain on most days for at least 3 months and average pain intensity score >=4.
• Clinical Dementia Rating 0.5 ≤ (CDR) ≤ 1.
• Participant will have capacity to consent.
• Participation of a study partner (e.g. caregiver/family member/significant other) is required.

Критерии исключения

• Deemed to have a significant suicide risk as assessed by site PI and clinical team.
• Deemed too unstable medically or neurologically to safely enroll in a research trial.
• Deemed too psychiatrically unstable to safely enroll in randomized trial of psychotherapy.
• Requiring psychiatric hospitalization at baseline for safety.
• Lack of English fluency.

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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Weill Cornell Medicine — White Plains

Идентификаторы

NCT: NCT05081596 · 21-01023108 · R01AG070055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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