A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions
NCT03487822
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Adult Trials: 18+ Years
Patient Participants:
- 60 and older
- chronic pain (pain on most days in past 2 months)
- negative emotions
- MoCA score 16 or higher
Provider Participants:
- providers 18 or over that took care of patient participant
- Patient Participants:
- MoCA score <16
- cancer related pain
- can not provide capacity to consent
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| Descriptive Information | |||||||
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| Brief Title ICMJE | A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions | ||||||
| Official Title ICMJE | A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions | ||||||
| Brief Summary | This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. Half the participants will receive the intervention, and half the participants will receive usual care with education. Intervention subjects are hypothesized to have significantly less pain-related disability versus usual care subjects after 24 weeks. | ||||||
| Detailed Description | This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. We propose that emotion regulation is the mechanism of change through which PATH-Pain improves pain and pain-related disability (outcomes). This pilot study will provide initial evidence of the: a) feasibility and acceptability of PATH-Pain; b) effects of PATH-Pain on emotion regulation (mechanism of change) and outcomes (pain and pain-related disability); and c) mediating effect of emotion regulation (mechanism of change) on outcomes (pain and pain-related disability). We will randomize 120 older adults (60 years or older) with chronic non-cancer related pain and negative emotions to PATH-Pain vs. Usual Care with Education (UCE). PATH-Pain will be administered by licensed mental health clinicians. Research assessments will be conducted at the Wright Center at study entry (baseline), and at 6, 12 (end of treatment), and 24 weeks. Additionally 20 providers of patients will be interviewed for feedback regarding the intervention. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Masking Description: The co-investigators performing assessments will be blind to the participant's arm. Primary Purpose: Supportive Care
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Path Pain
The intervention examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. This intervention consists of 8 weekly therapy sessions by a licensed clinician trained in Path Pain, 4 monthly boosters upon completion of therapy, and optional monthly group educational sessions. | ||||||
| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Suspended | ||||||
| Estimated Enrollment ICMJE | 140 | ||||||
| Original Estimated Enrollment ICMJE | 120 | ||||||
| Estimated Study Completion Date ICMJE | December 2020 | ||||||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria Patient Participants:
Provider Participants:
Exclusion Criteria - Patient Participants:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03487822 | ||||||
| Other Study ID Numbers ICMJE | 1509016564 28540451 ( Other Grant/Funding Number: Pfizer ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Weill Medical College of Cornell University | ||||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||||
| Collaborators ICMJE | Pfizer | ||||||
| Investigators ICMJE |
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| PRS Account | Weill Medical College of Cornell University | ||||||
| Verification Date | April 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||