Recruiting

Psychosocial Intervention

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05081596

Conditions

Depression

Pain

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

PATH-Pain

Study Details

Brief 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.

Conditions

Depression

Pain

Cognitive Impairment

Study ID

NCT05081596

Start date

Jun 3, 2022

Status verified date

Aug, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Dimtiris Kiosses, PhD

914-997-4381dkiosses@med.cornell.edu

Laurie Evans, MS

914-682-9100lad9011@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

White Plains, New York, United States, 10502

Contacts

Joanna Pantelides

914-997-5215jop2285@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Older Adults
  • Mild Cognitive Impairment
  • Early Stage Alzheimer's Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-20.