Psychosocial intervention to improve cognitive and depression outcomes in older adults with mild cognitive impairment and early Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial examines the effects of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive functioning, depression, and pain-related disability in older adults diagnosed with mild cognitive impairment (MCI) or early-stage Alzheimer's disease (AD). The study involves a randomized control trial design, where participants will receive either PATH-Pain or Attention Control Usual Care over a series of therapy sessions. The intervention consists of 8 in-office sessions followed by 6 telephone sessions, focusing on improving cognitive, affective, and functional outcomes. Assessments will be conducted at various intervals to evaluate the efficacy of the intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Weill Cornell Medicine
  White Plains, New York, United States Recruiting

Study contacts

• Principal investigator: Dimitris Kiosses, PhD — Weill Medical College of Cornell University
• Study coordinator: Dimtiris Kiosses, PhD
• Email: dkiosses@med.cornell.edu
• Phone: 914-997-4381

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effects of Transcutaneous Vagal Nerve Stimulation on Return to Consciousness After Surgery

  This study tests whether noninvasive tcVNS can help people wake up faster after surgery and reduce delirium and depression in the recovery period.

  Recruiting Northwestern University · Chicago, Illinois · NCT07610655

• Assessing visual frailty in older adults with age-related macular degeneration

  This study is trying to see if a new tool can help understand how vision problems affect older adults with advanced age-related macular degeneration and their overall health.

  Recruiting University of Edinburgh · Edinburgh, Scotland and 1 other locations · NCT06604104

• Investigating brain activity during cognitive tasks

  This study is testing how brain activity changes during thinking and memory tasks in people who need surgery, to help find better treatments for cognitive issues like dementia and attention disorders.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT05927974

• Smartphone-supported single-session psychotherapy for postpartum depression

  A single online therapy session plus four weeks of app-based support is being tested to see if it reduces depressive symptoms in postpartum women compared with a waitlist.

  Recruiting University of Sao Paulo · São Paulo, São Paulo · NCT07925762

• Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges

  This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.

  Recruiting Brown University · Providence, Rhode Island · NCT07892807

• Tele-based wellbeing centres for women's mental health in Bangladesh

  A randomized trial tests whether tele-counselling for depression and anxiety in Bangladeshi women is as effective as in-person counselling.

  Recruiting at 2 sites International Centre for Diarrhoeal Disease Research, Bangladesh · Chāndpur, Matlab Dakshin and 1 other locations · NCT07890896

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.