Trial Outcomes & Findings for Adaptability and Resilience in Aging Adults-2 (NCT NCT04068922)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

63 participants

Primary outcome timeframe

Assessed Weekly up to 8 Weeks

Results posted on

2024-07-31

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	63
Overall Study Received Intervention	59
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	5
Overall Study Withdrawal by Subject	7
Overall Study Adverse Event	1

Baseline Characteristics

Adaptability and Resilience in Aging Adults-2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Resilience Intervention n=50 Participants 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.
Age, Continuous	68.98 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Resilience Intervention n=50 Participants 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.
Session-level Engagement	6.3 score on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Resilience Intervention n=50 Participants 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.
Treatment Satisfaction	3.4 score on a scale Standard Deviation 0.50

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Resilience Intervention n=50 Participants 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.
Treatment Credibility and Expectancy	7.7 score on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Resilience Intervention n=50 Participants 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.
Satisfaction With Intervention Content	2.9 score on a scale Standard Deviation 0.78

PRIMARY outcome

Timeframe: Baseline to Week 1

Percentage of participants who are enrolled in the study and commence treatment/intervention.

Outcome measures

Outcome measures
Measure	Resilience Intervention n=63 Participants 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.
Intervention Commencement Rate	59 Participants

PRIMARY outcome

Timeframe: Baseline to 8 Weeks

Percentage of participants who commence treatment/intervention and complete the 8-week time-point.

Outcome measures

Outcome measures
Measure	Resilience Intervention n=59 Participants 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.
Participant Retention	50 Participants

PRIMARY outcome

Timeframe: Baseline to 8 Weeks

Percentage completion rates of primary outcome study measures (averaged across all sessions).

Outcome measures

Outcome measures
Measure	Resilience Intervention n=50 Participants 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.
Questionnaire Feasibility	96.8 percentage of completion Interval 92.0 to 100.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Resilience Intervention n=50 Participants 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.
Home Activity Feasibility	4.6 score on a scale Standard Deviation 0.88

Adverse Events

Resilience Intervention

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Resilience Intervention n=63 participants at risk 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.
Renal and urinary disorders Bladder Infection	1.6% 1/63 • 8 Weeks
Musculoskeletal and connective tissue disorders Fractured Toe	1.6% 1/63 • 8 Weeks
Blood and lymphatic system disorders Blood Clot	1.6% 1/63 • 8 Weeks
Reproductive system and breast disorders Enlarged Prostate	1.6% 1/63 • 8 Weeks
Musculoskeletal and connective tissue disorders Severe Back Pain and Numbness in Leg	1.6% 1/63 • 8 Weeks
Cardiac disorders Heart Attack	1.6% 1/63 • 8 Weeks
Infections and infestations Unspecified Illness	3.2% 2/63 • 8 Weeks

Additional Information

Dr. Emily Bartley

University of Florida

Phone: 352-273-8934

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place