RightFit
RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Problem Adaptation Therapy for Pain (PATH-Pain) in 100 adults age 60 or older with memory and thinking problems, long-term pain, and depression. It compares PATH-Pain with usual care that includes attention from study staff to see which better helps thinking, mood, and daily activities affected by pain.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 60 or older.
  • You have mild cognitive impairment (memory and thinking problems) or early possible or probable Alzheimer’s disease. Your MoCA thinking test score is 16–25.
  • You have at least some mild depression symptoms, with a MADRS depression test score of 5 or higher.
  • You either do not take antidepressants or the memory medicines called cholinesterase inhibitors or memantine, or your doses have stayed the same for at least 12 weeks.
  • You have had pain on most days for at least 3 months, with an average pain score of 4 or higher.
  • Your Clinical Dementia Rating, a measure of memory problems and their effect on daily life, is 0.5–1.
  • You can understand the study and agree to join.
  • A study partner, such as a caregiver, family member, or loved one, must take part.

Who can't join

  • The study team finds that you have a serious risk of suicide.
  • Your physical health or brain and nerve condition is too unstable for you to join safely.
  • Your mental health is too unstable for you to safely join a talk therapy study.
  • You need hospital care for mental health reasons to keep you safe at the start of the study.
  • You are not fluent in English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NY