A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PATH-Pain.
- Who it may be relevant to
- Registry conditions: Depression, Pain, Cognitive Impairment. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PATH-Pain: A Primary Care-Based Psychosocial Intervention To Improve Cognitive and Depression Outcomes in Older Adults With MCI and Early Stage AD
Overview
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.
Detailed description
This is a Randomized Control Trial to target cognition in older adults with MCI or Early AD, depression, and chronic pain with a psychotherapeutic intervention in primary care. This project will study the efficacy of 8 in-office acute treatment sessions (first 8 weeks) and 6 telephone delivered sessions (3 individual and 3 group) in the following months (from 9-36 weeks) of PATH- Pain vs. an equal number of sessions consisting of Attention Control Usual Care in improving cognitive, affective, and functional outcomes. Each therapy session will last approximately 50 minutes. Assessments will be conducted at study entry and weeks 5, 9 (end of acute treatment; includes assessment of cognitive functioning), 24, 36 (end of follow-up treatment; includes assessment of cognitive functioning) and 52 (includes assessments of cognitive functioning) after randomization. This is an efficacy trial, but by being delivered by certified mental health clinicians, it has a strong "real-world" focus.
Interventions
- Behavioral 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
Primary outcome measures
- Change in cognitive functioning, as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Time frame: Baseline, Weeks 9, 36, 52]
Secondary outcome measures (3)
- Change in cognition, as measured by the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG) [Time frame: Baseline, Weeks 9, 36, 52]
- Change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) [Time frame: Baseline, Weeks 5, 9, 24, 36, 52]
- Change in pain-related disability, as measured by the Roland-Morris Scale [Time frame: Baseline, Weeks 5, 9, 24, 36, 52]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Weill Cornell Medicine — White Plains
Identifiers
NCT: NCT05081596 · 21-01023108 · R01AG070055