N/A
N=95
Positive Affect as a Source of Resilience for Adults in Chronic Pain
Geriatric · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04869345 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Recruitment as Measured by Rates of Enrollment (Aim 1) — 120; 95; 22; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LARKSPUR (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment as Measured by Rates of Enrollment (Aim 1) |
120; 95; 22; 2; 1 | — |
| PRIMARY Retention as Measured by Change in Enrollment |
43; 43 | .684 |
| PRIMARY Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1) |
8.89; 9.05; 9.14; 8.59 | — |
| PRIMARY Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1) |
4.06 | — |
| SECONDARY Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) |
63.64; 62.79; 61.22; 61.49; 61.99; 61.55 | 0.835 |
| SECONDARY Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) |
63.63; 62.78; 61.77; 62.60; 62.11; 60.73 | 0.445 |
| SECONDARY Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) |
36.72; 36.99; 38.71; 38.46; 39.39; 38.18 | 0.792 |
| SECONDARY Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) |
66.88; 62.79; 62.32; 61.55; 61.96; 63.62 | 0.601 |
| SECONDARY Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2) |
1.26; 1.19; 1.13; 1.07; 1.39; 1.26 | 0.479 |
| SECONDARY Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2) |
1.94; 1.99; 2.26; 2.15; 2.49; 2.39 | 0.389 |
| SECONDARY Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2) |
1.94; 1.99; 1.88; 1.90; 2.04; 1.98 | 0.933 |
| SECONDARY Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) |
1.87; 1.65; 1.55; 1.65; 1.48; 1.69 | 0.403 |
Summary
Fibromyalgia syndrome (FMS) is a chronic musculoskeletal condition characterized by widespread pain and tenderness, and often accompanied by impaired physical functioning, depressed mood, as well as deficits in positive affect (PA).Standard behavioral therapies typically focus on minimizing negative thoughts and emotions associated with pain and yield only modest treatment effects. Efforts are therefore needed to develop more effective psychological treatments for chronic pain by identifying new targets for intervention.
The objectives of this Stage I randomized pilot trial are to evaluate the feasibility, acceptability, and the impact of a previously developed online positive affect (PA) skills intervention -LARKSPUR (Lessons in Affect Regulation to Keep Stress and Pain UndeR control)-in a sample of Hispanic, non-Hispanic other, and non-Hispanic African American patients with fibromyalgia syndrome (FMS).
Eligibility Criteria
Inclusion Criteria
- Access to daily internet
- ≥ 50 years of age
- Able to read and understand English
- Physician diagnosis confirmation of FMS AND/OR Score ≥ 13 on the 6-item, self-report fibromyalgia screening tool
- Report having pain for at least the last three months
Exclusion Criteria
- Cognitive impairment
- Current behavioral treatment for pain
- Enrolled in another pain study
Data sourced from ClinicalTrials.gov (NCT04869345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.