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| ID | Type | Description | Link |
|---|---|---|---|
| 5R00AG052642-05 | U.S. NIH Grant/Contract | View source | |
| 5K99AG052642-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resilience Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resilience Intervention | Behavioral | Resilience skills training including: pleasant activities, hope/goal-setting, pain acceptance, positive events/reappraisals, and self-efficacy. |
| 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 and mean scored, with the mean value across sessions calculated. Higher scores indicate greater treatment engagement. | Assessed Weekly up to 8 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. A mean score is calculated for the questionnaire, with higher scores indicating greater treatment credibility. | Baseline |
| 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 |
| Intervention Commencement Rate | Percentage of participants who are enrolled in the study and commence treatment/intervention. | Baseline to Week 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Bartley, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34666839 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Number represents the participants who completed the intervention (out of 59 who were enrolled and commenced the intervention)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed Weekly up to 8 Weeks |
|
8 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder Infection | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Bartley | University of Florida | 352-273-8934 | ebartley@dental.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2021 | May 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2022 | May 30, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Participant Retention |
Percentage of participants who commence treatment/intervention and complete the 8-week time-point. |
| Baseline to 8 Weeks |
| Questionnaire Feasibility | Percentage completion rates of primary outcome 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 and mean scored, with the mean value across sessions calculated. Higher scores indicate greater feasibility of home activity completion. | Assessed Weekly up to 8 Weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. A mean score is calculated for the questionnaire, with higher scores indicating greater treatment credibility. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 Weeks |
|
|
|
| Primary | Intervention Commencement Rate | Percentage of participants who are enrolled in the study and commence treatment/intervention. | Posted | Count of Participants | Participants | Baseline to Week 1 |
|
|
|
| Primary | Participant Retention | Percentage of participants who commence treatment/intervention and complete the 8-week time-point. | Posted | Count of Participants | Participants | Baseline to 8 Weeks |
|
|
|
| Primary | Questionnaire Feasibility | Percentage completion rates of primary outcome study measures (averaged across all sessions). | Posted | Mean | Full Range | percentage of completion | 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 and mean scored, with the mean value across sessions calculated. Higher scores indicate greater feasibility of home activity completion. | Posted | Mean | Standard Deviation | score on a scale | Assessed Weekly up to 8 Weeks |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 8 |
| 63 |
| Fractured Toe | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Blood Clot | Blood and lymphatic system disorders | Systematic Assessment |
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| Enlarged Prostate | Reproductive system and breast disorders | Systematic Assessment |
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| Severe Back Pain and Numbness in Leg | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Heart Attack | Cardiac disorders | Systematic Assessment |
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| Unspecified Illness | Infections and infestations | Systematic Assessment |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |