ARIAA-2: Adaptability and Resilience in Aging Adults-2

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT04068922

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arm

27.3

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging Chronic Low-back Pain	Behavioral: Resilience Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Adaptability and Resilience in Aging Adults-2

Actual Study Start Date :

Jan 21, 2020

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Session-level engagement [Up to 7 Weeks]
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.
Treatment satisfaction [8 Weeks]
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.
Treatment credibility and expectancy [Baseline and Week 1]
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.
Satisfaction with intervention content [8 Weeks]
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.
Enrollment rate [Baseline to Week 1]
Percentage of participants who enroll that commence treatment.
Percentage of enrolled participant retention [Baseline to 8 Weeks]
Percentage of enrolled participants who complete the 8-week time-point.
Questionnaire feasibility [Baseline to 8 Weeks]
Completion rates of study measures (averaged across all sessions).
Home activity feasibility [Up to 6 Weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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