Adaptability and Resilience in Aging Adults-2

Aging Clinical Trial

— ARIAA-2  

Official title:

Adaptability and Resilience in Aging Adults-2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068922
• Other study ID #: IRB201802729
• Secondary ID: 5R00AG052642-055
• Status: Completed
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Enrollment rate	Percentage of participants who enroll that commence treatment.	Baseline to Week 1
Primary	Percentage of enrolled participant retention	Percentage of enrolled participants who complete the 8-week time-point.	Baseline to 8 Weeks
Primary	Questionnaire feasibility	Completion rates of study measures (averaged across all sessions).	Baseline to 8 Weeks
Primary	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