Clinical trial NCT04068922: Adaptability and Resilience in Aging Adults-2
Official title: Adaptability and Resilience in Aging Adults-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Chronic Low-back Pain
Keywords: aging
resilience
low back pain
positive affect
hope
self-efficacy
acceptance
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-08-28
Enrollment: 63
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic low back pain is a major health concern among older adults and is associated with increased economic, functional, and psychological burden. Resilience has been highlighted as a crucial factor in positive health-related functioning, and a growing body of literature supports the use of resilience-based interventions in chronic pain. Therefore, the goals of this project are to examine the feasibility and acceptability of a resilience intervention for chronic low back pain among older adults.

Detailed description: Chronic pain is one of the leading causes of disability, affecting over 100 million people in the United States and resulting in tremendous health care costs and psychological burden. Older adults are disproportionately impacted by pain, with an estimated 60-70% of people over the age of 65 reporting persistent pain. Despite this, pain management is frequently suboptimal among older adults as pharmacological therapies show limited clinical efficacy and a greater risk of adverse effects, and nonpharmacological (e.g., psychological) treatments are often underutilized.

Resilience is conceptualized as adaptive functioning in the face of adversity and comprises a range of psychological, social, and physical resources. Increasing evidence suggests that modifiable resilience factors are associated with more favorable pain outcomes, including lower clinical pain/disability, higher quality of life, and enhanced psychological and physical functioning. Although cross-sectional research supports the significance of these resilience factors in pain adaptation, and positive psychological therapies have been shown to yield improvements in health and well-being, strategies to augment resilience are understudied in individuals with chronic pain.

Using a Stage Model approach,the aim of this project is to conduct a Stage I pilot study and examine the feasibility and acceptability of a resilience intervention for chronic low back pain among older adults. Intervention modules will specifically engage hope, self-efficacy, positive affect, and pain acceptance.

Eligibility criteria: Inclusion Criteria:

* Age 60 and older
* Low back pain on at least half the days over the previous 6 months
* Average daily back pain score ≥3 on a 0-10 numerical rating scale
* At least moderate (≥3/10) CLBP-related interference on a 0-10 numerical rating scale
* Able to read/write in English

Exclusion Criteria:

* Current participation in another psychological treatment
* Severe psychiatric illness not adequately controlled by medication (e.g., schizophrenia, bipolar disorder) or other conditions anticipated to impair intervention engagement (e.g., substance abuse/dependence)
* Presence of chronic, malignant pain (e.g., HIV, cancer) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.)
* Significant cognitive impairment on the MoCA
* If currently taking prescription analgesic or psychotropic medication, must be stabilized on these treatments for ≥4 weeks prior to the baseline assessment

Primary outcomes:
measure: Session-level Engagement
timeFrame: Assessed Weekly up to 8 Weeks
measure: Treatment Satisfaction
timeFrame: 8 Weeks
measure: Treatment Credibility and Expectancy
timeFrame: Baseline
measure: Satisfaction With Intervention Content
timeFrame: 8 Weeks
measure: Intervention Commencement Rate
timeFrame: Baseline to Week 1
measure: Participant Retention
timeFrame: Baseline to 8 Weeks
measure: Questionnaire Feasibility
timeFrame: Baseline to 8 Weeks
measure: Home Activity Feasibility
timeFrame: Assessed Weekly up to 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Emily Bartley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lysne PE, Palit S, Morais CA, DeMonte LC, Lakdawala M, Sibille KT, Bartley EJ. Adaptability and Resilience in Aging Adults (ARIAA): protocol for a pilot and feasibility study in chronic low back pain. Pilot Feasibility Stud. 2021 Oct 19;7(1):188. doi: 10.1186/s40814-021-00923-y.