Pain / Cognitive Impairment / Depression · Interventional Study

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

ClinicalTrials.gov · August 20, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This registry record describes a planned primary care–based behavioral trial (PATH-Pain) in older adults with cognitive impairment, depression, and chronic pain, comparing cognitive and mood outcomes over 52 weeks against attention control. No results are reported in this registry entry; the study remains actively recruiting.

What was studied

Interventional, Randomized, Parallel, Open label, Treatment purpose. Depression, Pain, Cognitive Impairment; age from 60 Years. Intervention: Problem Adaptation Therapy for Pain (PATH-Pain). Compared with: Attention Control Usual Care — No Intervention. n = 100. 1 site: United States.

Key findings

Safety

This is a study registration only; no efficacy or safety results are reported in this source.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active recruiting trial with no reported results; the registry record describes planned design and enrollment only, making it a preliminary registration document rather than evidence of efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change in cognitive functioning, as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (assessed at Baseline, Weeks 9, 36, 52)

DesignInterventional, Randomized, Parallel, Open label, Treatment purpose

PopulationDepression, Pain, Cognitive Impairment; age from 60 Years

Sample size100

InterventionProblem Adaptation Therapy for Pain (PATH-Pain)

ComparatorAttention Control Usual Care — No Intervention

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Estimated enrollment100

Primary outcome measureChange in cognitive functioning via RBANS at Baseline, Weeks 9, 36, 52

Study phaseNA

Caveats

This is a study registration only; no efficacy or safety results are reported in this source.
Study recruitment status is active; final sample size, completion date, and outcome data are not yet available.
Blinding, allocation concealment, and analytic methods are not described in the registry record.
Comparator is described only as 'Attention Control Usual Care' with no specification of its content or delivery.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Planned comparison of behavioral intervention versus attention control; no blinding details provided.

Directness

strong

Primary outcome directly measures cognitive functioning via RBANS in target population.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

No information on allocation concealment, blinding, or dropout mitigation strategies.

Sample adequacy

limited

Estimated enrollment of 100 participants; final sample size and power analysis not stated.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05081596). This is a study registration, not published results. Lead sponsor: Weill Medical College of Cornell University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Depression, Pain, Cognitive Impairment. Interventions: BEHAVIORAL: PATH-Pain. Primary outcome measures: Change in cognitive functioning, as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) , Baseline, Weeks 9, 36, 52. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

PainNCT05081596Cognitive ImpairmentDepressionWeill Medical College of Cornell UniversityPATH-Pain