Psychosocial Intervention for Cognitive Impairment and Depression

(PATH-Pain Trial)

Overseen By Dimtiris Kiosses, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must not be taking: Antidepressants, Cholinesterase inhibitors, Memantine

Disqualifiers: Significant suicide risk, Medically unstable, Psychiatrically unstable, Psychiatric hospitalization, Lack of English fluency

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 50

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a therapy called PATH-Pain to determine its effectiveness for older adults with memory problems, chronic pain, and depression. PATH-Pain teaches ways to manage emotions and reduce stress, aiming to improve cognitive function, mood, and daily activities. The study compares PATH-Pain to the usual care provided by doctors. Participants should have cognitive issues like mild memory loss, feel down or depressed, and experience chronic pain most days. A caregiver or family member must join participants in the study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance quality of life for many.

Will I have to stop taking my current medications?

The trial requires that participants either stop taking antidepressants, cholinesterase inhibitors, or memantine, or be on a stable dosage for at least 12 weeks before joining.

What prior data suggests that PATH-Pain is safe for older adults with cognitive impairment, chronic pain, and depression?

Research has shown that Problem Adaptation Therapy for Pain (PATH-Pain) is generally easy for participants to handle. In studies involving older adults with ongoing pain, depression, and memory or thinking problems, no major safety issues were found.

PATH-Pain is a therapy designed to manage stress and reduce feelings of depression and disability. Earlier research found it lessened pain-related disability and depression without significant side effects. This suggests PATH-Pain is a safe option for many, especially those facing both pain and emotional challenges.

Although PATH-Pain appears safe based on past studies, participants should discuss any concerns with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

PATH-Pain is unique because it focuses on emotion regulation to tackle stress, depression, and disability, which is a fresh approach compared to traditional medications or therapy sessions. Most treatments for depression and cognitive impairment rely on pharmaceuticals or cognitive-behavioral therapy, but PATH-Pain works differently by specifically targeting the emotional triggers related to pain and stress. Researchers are excited about this treatment because it has the potential to provide relief without the side effects that can come with medication, offering a more holistic and sustainable way to improve mental health and quality of life.

What evidence suggests that PATH-Pain might be an effective treatment for cognitive impairment, depression, and pain-related disability?

Research has shown that Problem Adaptation Therapy for Pain (PATH-Pain), which participants in this trial may receive, can reduce pain-related disability and depression in older adults. Studies have found that individuals using PATH-Pain experienced better outcomes in mood, thinking skills, and daily activities compared to those receiving usual care, another arm of this trial. PATH-Pain aims to lower stress and help manage emotions, which can reduce depression and disability. Early results suggest that PATH-Pain might benefit older adults with memory issues, long-term pain, and depression. Overall, this therapy appears promising for improving mood and daily life in these individuals. ^{1 6 7 8 9}

Who Is on the Research Team?

Lisa Ravdin, PhD

Principal Investigator

Weill Medical College of Cornell University

Dimitris Kiosses, PhD

Principal Investigator

Weill Medical College of Cornell University

Mannigton C Reid, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for older adults over 60 with mild cognitive impairment (MCI) or early-stage Alzheimer's Disease (AD), experiencing chronic pain and some depression. They must have a study partner, be on stable medication if any, and able to consent. Those not fluent in English, at risk of suicide, psychiatrically unstable, or too medically/neurologically unstable are excluded.

Inclusion Criteria

I experience mild or more severe symptoms of depression.

I have had chronic pain most days for at least 3 months with a pain level of 4 or more.

Clinical Dementia Rating 0.5 ≤ (CDR) ≤ 1

Exclusion Criteria

I need to be in a psychiatric hospital for my safety.

Deemed too psychiatrically unstable to safely enroll in randomized trial of psychotherapy

Lack of English fluency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Treatment

Participants receive 8 in-office acute treatment sessions over the first 8 weeks

8 weeks

8 visits (in-person)

Follow-up Treatment

Participants receive 6 telephone delivered sessions (3 individual and 3 group) from weeks 9 to 36

28 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Assessments at weeks 36 and 52

What Are the Treatments Tested in This Trial?

Interventions

• PATH-Pain

Trial Overview The trial tests Problem Adaptation Therapy for Pain (PATH-Pain) against usual care to see if it improves thinking abilities, mood, and how well people can handle their daily activities when they have memory problems and chronic pain.

How Is the Trial Designed?

Group I: Problem Adaptation Therapy for Pain (PATH-Pain) Experimental Treatment 1 Intervention

Problem Adaptation Therapy-PAIN (PATH-PAIN) is an emotion regulation intervention aimes to reduce stress and decrease depression and disability.

Group II: Attention Control Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Chronic pain and depression frequently co-occur in older adults, with a comorbidity rate of approximately 50%-65%, highlighting the need for comprehensive treatment strategies.

The review emphasizes the importance of interdisciplinary approaches, such as Functional Restoration, which combines physical rehabilitation and cognitive behavioral therapies to improve overall well-being and physical functioning in geriatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological treatment of depression in geriatric chronic pain patients: a biopsychosocial approach integrating functional restoration. Polatin, P., Bevers, K., Gatchel, RJ.[2017]

In a study of 688 healthy older adults over 10 years, baseline pain was linked to worse memory and faster decline in cognitive functions like processing speed.

Incident pain, reported by 42% of participants, was associated with accelerated declines in various cognitive areas, indicating that pain can significantly impact cognitive health in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal associations of pain and cognitive decline in community-dwelling older adults. Bell, TR., Sprague, BN., Ross, LA.[2023]

Using a biopsychosocial approach to create a pain model for patients is crucial for psychological interventions, as it helps identify and modify pain-related thoughts that influence behavior.

Group therapy combined with individual support can enhance coping strategies and self-efficacy, allowing patients to better manage stress and improve their overall functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychological therapy as part of an interdisciplinary treatment of chronic back pain]. Heinrich, M., Monstadt, D., Michel, C.[2021]

Chronic pain (CP) in older adults is linked to a significant decline in cognitive performance over 15 years, particularly affecting processing speed as measured by the Digit Symbol Substitution Test.

The study, which included 693 participants aged 65 and older, highlights the importance of treating chronic pain to potentially prevent cognitive decline, suggesting both pharmacological and nonpharmacological strategies should be employed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between chronic pain and long-term cognitive decline in a population-based cohort of elderly participants. Rouch, I., Edjolo, A., Laurent, B., et al.[2022]

Pain detection and treatment in individuals with cognitive disorders is challenging due to gaps in understanding how pain is experienced and expressed across different cognitive conditions.

There is a critical need for improved assessment methods for pain in these populations, as well as effective interdisciplinary treatment strategies and better education on pain management for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pain and neurocognitive disorders: current state of the art and remaining challenges]. Achterberg, WP., de Waal, MWM., Cheuk-A-Lam-Balrak, JMJJ., et al.[2023]

Psychosocial interventions have been found to significantly reduce pain scores and the need for pain medication in older adults with dementia, based on a systematic review of eight studies.

Despite the promising results, the overall quality of evidence is low to moderate, highlighting the need for more rigorous research to confirm the effectiveness of these interventions in pain management for dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial interventions for pain management in older adults with dementia: A systematic review of randomized controlled trials. Pu, L., Moyle, W., Jones, C., et al.[2020]

Problem Adaptation Therapy for Pain in Primary Care (PATH-Pain) is a new psychosocial intervention designed specifically for older adults with chronic pain and cognitive impairments, addressing the gap in treatment options for this population.

The therapy aims to help older adults manage negative emotions associated with chronic pain, potentially improving their quality of life and social functioning, which is crucial given the high prevalence of chronic pain in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem Adaptation Therapy for Pain (PATH-Pain): A Psychosocial Intervention for Older Adults with Chronic Pain and Negative Emotions in Primary Care. Kiosses, DN., Ravdin, LD., Stern, A., et al.[2023]

In a study of 2822 cognitively impaired nursing home residents, 19.1% reported experiencing pain, which was significantly linked to various behavioral and psychiatric symptoms such as socially inappropriate behavior and resistance to care.

The findings suggest that addressing pain in elderly patients could be crucial for managing behavioral and psychiatric symptoms, highlighting the need for integrated treatment approaches that consider both pain management and mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of pain with behavioral and psychiatric symptoms among nursing home residents with cognitive impairment: results from the SHELTER study. Tosato, M., Lukas, A., van der Roest, HG., et al.[2022]

The study evaluated a multi-dimensional tool for assessing pain in cognitively impaired adults, revealing that certain pain indicators were more frequently observed and documented, particularly during morning shifts.

Nurses' compliance in recording pain observations was inconsistent, highlighting the need for better training and support to enhance pain assessment practices, which should combine physiological and behavioral indicators based on clinical judgment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain assessment and cognitive impairment: part 2. Davies, E., Male, M., Reimer, V., et al.[2019]

In a study of 117 veterans with chronic pain undergoing 8 weeks of acceptance and commitment therapy (ACT), participants showed significant improvements in pain interference, severity, quality of life, and mental health outcomes from baseline to post-treatment.

Lower neuropsychological (NP) performance, particularly in executive functioning and processing speed, was linked to greater reductions in depressive symptoms and pain-related anxiety, suggesting that individuals with lower NP functioning may benefit more from psychosocial treatments like ACT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological Functioning and Treatment Outcomes in Acceptance and Commitment Therapy for Chronic Pain. Herbert, MS., Afari, N., Robinson, JB., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12001379/

Problem Adaptation Therapy for Older Adults with Chronic ... This primarycarebased study demonstrates the short-term efficacy of PATH-Pain versus UC in reducing pain-related disability and depression in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224025079

Depression, cognitive, and functional outcomes of Problem ... PATH participants had better depression, cognitive, and disability outcomes than ST-CI participants over 6 months. PATH may provide relief to depressed older ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05081596

A Primary Care-Based Psychosocial Intervention To ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10262169/

Problem Adaptation Therapy (PATH): Origins, Current ... An intervention designed to help reduce depression and disability in older adults with major depression and cognitive impairment.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748124005657

Problem Adaptation Therapy for Older Adults with Chronic ... This primarycarebased study demonstrates the short-term efficacy of PATH-Pain versus UC in reducing pain-related disability and depression in older adults with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5640171/

Problem Adaptation Therapy for Pain (PATH-Pain) PATH-Pain is a psychosocial intervention for older adults with chronic pain, negative emotions, and a wide range of cognitive functioning, including mild-to- ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39875212/

Problem Adaptation Therapy for Older Adults with Chronic ... This primarycarebased study demonstrates the short-term efficacy of PATH-Pain versus UC in reducing pain-related disability and depression in older adults ...

8. researchgate.net researchgate.net/publication/267873325_Problem_Adaptation_Therapy_for_Older_Adults_With_Major_Depression_and_Cognitive_Impairment_A_Randomized_Clinical_Trial

Problem Adaptation Therapy for Older Adults With Major ... An RCT comparing 12-week PATH with supportive therapy in 74 older adults with major depression, cognitive impairment, and disability to the ...

9. researchgate.net researchgate.net/publication/387769577_Problem_Adaptation_Therapy_for_Older_Adults_with_Chronic_Pain_and_Negative_Emotions_in_Primary_Care_PATH-Pain_A_Randomized_Clinical_Trial

Problem Adaptation Therapy for Older Adults with Chronic ... The prevalence rate of MCR was 11.66%. The results revealed that chronic pain, age, falls, depression, social support, living conditions, medication types, ...