AgingARIAA-2NCT04068922
Adaptability and Resilience in Aging Adults-2
A study testing Resilience Intervention in people with Aging and Chronic Low-back Pain, run by University of Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging, Chronic Low-back Pain
- What is being tested?
- Resilience Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2020to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Aging, Chronic Low-back Pain
- Being tested
- Resilience Intervention
- Keywords
- aging, resilience, low back pain, positive affect, hope, self-efficacy, acceptance
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience InterventionBehavioural
Resilience skills training including: pleasant activities, hope/goal-setting, pain acceptance, positive events/reappraisals, and self-efficacy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Resilience Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 Weeks
Intervention Commencement Rate
Percentage of participants who are enrolled in the study and commence treatment/intervention.
Measured: Baseline to Week 1
Participant Retention
Percentage of participants who commence treatment/intervention and complete the 8-week time-point.
Measured: Baseline to 8 Weeks
Questionnaire Feasibility
Percentage completion rates of primary outcome study measures (averaged across all sessions).
Measured: 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.
Measured: Assessed Weekly up to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start21 Jan 2020
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Emily Bartley, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068922
- Sponsor's protocol ID
- IRB201802729
- Other IDs
- 5R00AG052642-05, 5K99AG052642-02
- Acronym
- ARIAA-2
- Status last verified
- Jul 2024
- First submitted
- 23 Aug 2019
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34666839
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptability and Resilience in Aging Adults-2
- ClinicalTrials.gov ID
- NCT04068922
- Acronym / sponsor ID
- ARIAA-2 / IRB201802729
- Conditions
- Aging, Chronic Low-back Pain
- Keywords
- aging, resilience, low back pain, positive affect, hope, self-efficacy, acceptance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resilience Intervention | Experimental | Behavioral: Resilience InterventionParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilience InterventionResilience skills training including: pleasant activities, hope/goal-setting, pain acceptance, positive events/reappraisals, and self-efficacy. | Behavioural | Resilience Intervention |
Primary outcome
Session-level Engagement
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 1
Percentage of participants who are enrolled in the study and commence treatment/intervention.
Participant Retention
Time frame: Baseline to 8 Weeks
Percentage of participants who commence treatment/intervention and complete the 8-week time-point.
Questionnaire Feasibility
Time frame: Baseline to 8 Weeks
Percentage completion rates of primary outcome study measures (averaged across all sessions).
Home Activity Feasibility
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34666839Lysne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Bartley, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience Intervention in people with Aging and Chronic Low-back Pain, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Session-level Engagement (time frame: Assessed Weekly up to 8 Weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04068922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.