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Adaptability and Resilience in Aging Adults-2
NA trial testing Resilience Intervention in Aging in 63 participants. Completed in 31 May 2023.
| Lead sponsor | University of Florida |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 63 |
| Start date | 21 January 2020 |
| Primary completion | 31 May 2023 |
| Estimated completion | 31 May 2023 |
| Sites | 1 location across United States |
University of Florida
60 and older, any sex, with Aging or Chronic Low-back Pain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Resilience Intervention | 6.3 | ± 1.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Resilience Intervention | 3.4 | ± 0.50 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Resilience Intervention | 7.7 | ± 1.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Resilience Intervention | 2.9 | ± 0.78 |
Percentage of participants who are enrolled in the study and commence treatment/intervention.
| Group | Value | 95% CI |
|---|---|---|
| Resilience Intervention | 59 |
Percentage of participants who commence treatment/intervention and complete the 8-week time-point.
| Group | Value | 95% CI |
|---|---|---|
| Resilience Intervention | 50 |
Percentage completion rates of primary outcome study measures (averaged across all sessions).
| Group | Value | 95% CI |
|---|---|---|
| Resilience Intervention | 96.8 | 92.0 – 100.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Resilience Intervention | 4.6 | ± 0.88 |
Time frame: 8 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Resilience Intervention |
|---|---|---|
| Unspecified Illness | Infections and infestations | — |
| Bladder Infection | Renal and urinary disorders | — |
| Fractured Toe | Musculoskeletal and connective tissue disorders | — |
| Blood Clot | Blood and lymphatic system disorders | — |
| Enlarged Prostate | Reproductive system and breast disorders | — |
| Severe Back Pain and Numbness in Leg | Musculoskeletal and connective tissue disorders | — |
| Heart Attack | Cardiac disorders | — |
Data from ClinicalTrials.gov NCT04068922 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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