Adaptability and Resilience in Aging Adults-2 (ARIAA-2)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain; Aging
• Intervention / Treatment: Behavioral: Resilience Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Resilience Intervention; Participants will initially complete a baseline assessment assessing study eligibility. The Resilience intervention consists of seven weekly 1.5-hour group sessions guided by trained clinicians. Due to the COVID-19 pandemic, these group session may be conducted through Zoom. Skills and content will be directed toward improving pain management by enhancing positive emotions, setting goals, learning to live a life according to one's values, and boosting self-confidence in one's ability to manage pain. Self-administered activities include the identification of personal strengths, pleasant activity scheduling, expressing gratitude, values clarification, mindfulness practice, goal setting, positive reappraisal, and noting positive events.

Behavioral: Resilience Intervention; Resilience skills training including: pleasant activities, hope/goal-setting, pain acceptance, positive events/reappraisals, and self-efficacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Session-level engagement	Treatment Engagement Questionnaire: 6-item study-adapted questionnaire assessing perceptions of engagement, interest in the session content, and usefulness of the home activities. Items are rated on a 0 to 8 scale with the mean value across sessions calculated. Higher scores indicate greater treatment engagement.	Up to 7 Weeks
Treatment satisfaction	8-item Client Satisfaction Questionnaire: Response to self-reported quality of the treatment, willingness to recommend the treatment, and general satisfaction with the treatment. Items are rated on a 1 to 4 scale with the mean value calculated. Higher scores indicate greater satisfaction with the treatment.	8 Weeks
Treatment credibility and expectancy	Treatment Expectation Questionnaire: 7-item study-adapted questionnaire assessing the credibility and reasonableness of the intervention, and expectation for change in pain symptoms. Items are rated on a 0 to 10 scale or a 0% to 100% scale. Higher scores indicate greater treatment credibility and expectation for improvement.	Baseline and Week 1
Satisfaction with intervention content	Intervention Content Satisfaction Questionnaire: 33-item study-developed questionnaire assessing the usefulness of each intervention session module and home activity. Items are rated on a 0 to 4 scale with the mean value calculated. Higher scores indicate greater satisfaction with the intervention content.	8 Weeks
Enrollment rate	Percentage of participants who enroll that commence treatment.	Baseline to Week 1
Percentage of enrolled participant retention	Percentage of enrolled participants who complete the 8-week time-point.	Baseline to 8 Weeks
Questionnaire feasibility	Completion rates of study measures (averaged across all sessions).	Baseline to 8 Weeks
Home activity feasibility	Home Activities Questionnaire: 3-item study-adapted questionnaire assessing the degree of home-activity completion, level of understanding regarding home activities, and degree of time and effort needed to complete activities. Items are rated on a 0 to 6 scale with the mean value across sessions calculated. Higher scores indicate greater feasibility of home activity completion.	Up to 6 Weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Emily Bartley, PhD, University of Florida

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: low back pain; aging; self-efficacy; resilience; hope; positive affect; acceptance
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB201802729; 5R00AG052642-05 (U.S. NIH Grant/Contract); 5K99AG052642-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No