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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
Weill Cornell Medicine
RECRUITING
White Plains
Contact Information
Primary
Dimtiris Kiosses, PhD
dkiosses@med.cornell.edu
914-997-4381
Backup
Laurie Evans, MS
lad9011@med.cornell.edu
914-682-9100
Time Frame
Start Date: 2022-06-03
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 100
Treatments
Experimental: Problem Adaptation Therapy for Pain (PATH-Pain)
Problem Adaptation Therapy-PAIN (PATH-PAIN) is an emotion regulation intervention aimes to reduce stress and decrease depression and disability.
No_intervention: Attention Control Usual Care
Usual Care involves the continued medical attention and treatment provided by the subject's physician and other medical professionals in primary care. This may include medical intervention or referrals to specialists to address issues of depression, pain or memory difficulties. Subjects will also be asked to meet with a study research assistant for structured interviews and educational sessions consisting of general questions regarding health habits and other non-medical topics unrelated to cognitive impairment, pain, and depression. Additionally, subjects will receive an educational booklet on pain and depression.
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov