RECRUITINGINTERVENTIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Treatments Being Tested

BEHAVIORAL

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 be used to help the subject with emotion regulation techniques. The tablet will be given at the beginning of treatment and will be returned at the end of treatment. 3) Invite caregiver participation, when appropriate. Subjects in the PATH-PAIN group will receive 8 weekly sessions (first 8 weeks) with a study therapist and 6 monthly phone sessions (3 individual and 3 group) for 9-36 weeks. Each session will last approximately 50 minutes.

Locations (1)

Weill Cornell Medicine

White Plains, New York, United States