Aging, Chronic Low-back Pain
Conditions
Keywords
aging, resilience, low back pain, positive affect, hope, self-efficacy, acceptance
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.
Interventions
BEHAVIORALResilience Intervention
Resilience skills training including: pleasant activities, hope/goal-setting, pain acceptance, positive events/reappraisals, and self-efficacy.
Sponsors
National Institute on Aging (NIA)
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Session-level Engagement | Assessed Weekly up to 8 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 and mean scored, 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 | 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. A mean score is calculated for the questionnaire, with higher scores indicating greater treatment credibility. |
| 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. |
| Intervention Commencement Rate | Baseline to Week 1 | Percentage of participants who are enrolled in the study and commence treatment/intervention. |
| Participant Retention | Baseline to 8 Weeks | Percentage of participants who commence treatment/intervention and complete the 8-week time-point. |
| Questionnaire Feasibility | Baseline to 8 Weeks | Percentage completion rates of primary outcome study measures (averaged across all sessions). |
| Home Activity Feasibility | Assessed Weekly up to 8 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 and mean scored, with the mean value across sessions calculated. Higher scores indicate greater feasibility of home activity completion. |
Countries
United States
Participant flow
Recruitment details
Recruitment for this single-arm clinical trial began in January 2020, with the last participant enrolled in July 2022. Participants with chronic low back pain were recruited via provider referral, study flyers, radio and newspaper advertisement, health fairs, social media, and registries maintained by the Pain Research & Intervention Center of Excellence and the Clinical and Translational Science Institute at the University of Florida.
Pre-assignment details
Of the 200 individuals who expressed interest in the study or who met initial eligibility criteria, 63 participants were eligible and enrolled. Of the 63 individuals who were enrolled, 94% of participants commenced treatment.
Participants by arm
| Arm | Count |
|---|---|
| Resilience Intervention The Resilience intervention consisted of seven weekly 1.5-hour group sessions guided by trained clinicians. Skills and content targeted 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 included the identification of personal strengths, pleasant activity scheduling, expressing gratitude, values clarification, mindfulness practice, goal setting, positive reappraisal, and noting positive events.
Resilience Intervention: Resilience skills training including: pleasant activities, hope/goal-setting, pain acceptance, positive events/reappraisals, and self-efficacy. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Resilience Intervention |
|---|---|
| Age, Continuous | 68.98 years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 63 |
| other Total, other adverse events | 8 / 63 |
| serious Total, serious adverse events | 0 / 63 |
Outcome results
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 and mean scored, with the mean value across sessions calculated. Higher scores indicate greater feasibility of home activity completion.
Time frame: Assessed Weekly up to 8 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resilience Intervention | Home Activity Feasibility | 4.6 score on a scale | Standard Deviation 0.88 |
Primary
Intervention Commencement Rate
Percentage of participants who are enrolled in the study and commence treatment/intervention.
Time frame: Baseline to Week 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Resilience Intervention | Intervention Commencement Rate | 59 Participants |
Primary
Participant Retention
Percentage of participants who commence treatment/intervention and complete the 8-week time-point.
Time frame: Baseline to 8 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Resilience Intervention | Participant Retention | 50 Participants |
Primary
Questionnaire Feasibility
Percentage completion rates of primary outcome study measures (averaged across all sessions).
Time frame: Baseline to 8 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resilience Intervention | Questionnaire Feasibility | 96.8 percentage of completion |
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.
Time frame: 8 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resilience Intervention | Satisfaction With Intervention Content | 2.9 score on a scale | Standard Deviation 0.78 |
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 and mean scored, with the mean value across sessions calculated. Higher scores indicate greater treatment engagement.
Time frame: Assessed Weekly up to 8 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resilience Intervention | Session-level Engagement | 6.3 score on a scale | Standard Deviation 1 |
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. A mean score is calculated for the questionnaire, with higher scores indicating greater treatment credibility.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resilience Intervention | Treatment Credibility and Expectancy | 7.7 score on a scale | Standard Deviation 1.6 |
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.
Time frame: 8 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resilience Intervention | Treatment Satisfaction | 3.4 score on a scale | Standard Deviation 0.5 |