Clinical trial NCT04869345: Positive Affect as a Source of Resilience for Adults in Chronic Pain
Official title: Feasibility of a Positive Affect Skills Intervention for Reducing Racial Disparities in Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric
Chronic Pain
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Cornell University
name: Wake Forest University
First posted: 2021-05-03
Enrollment: 95
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed description: Specific Aims:

Aim 1: To maximize relevance and acceptability of content and delivery of LARKSPUR intervention among patients with FMS, a chronic pain population with known deficits in PA. This aim will establish the feasibility (recruitment and retention) and acceptability (helpfulness, satisfaction, and impact) of the multicomponent LARKSPUR intervention in Hispanic, non-Hispanic African American and non-Hispanic other patients with FMS.

Aim 2: To conduct a randomized pilot trial to evaluate the impact of the LARKSPUR intervention in FMS pain (primary outcome), as well PA, depressive symptoms, physical functioning, and stress appraisals (secondary outcomes) and Aim 2a: explore racial/ethnic disparities.

For Aim 1, the study team will pilot LARKSPUR to examine feasibility and acceptability of the intervention framework by conducting frequency and descriptive statistics for enrollment rates, number of sessions completed, number of weeks required to complete the intervention, and Likert-scale items assessing satisfaction with the intervention and perceived helpfulness. For Aims 2, FMS patients (target N=90) will be randomized to receive the LARKSPUR content online or to complete daily emotion reports online (control). The researchers hypothesize that intervention participants will report more frequent PA, decreased depressive symptoms, enhanced physical functioning, improved stress appraisals, and reduced FMS pain (intensity and interference) immediately following the intervention (approximately 6-8 wks) and at 1-month post-intervention.

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

Primary outcomes:
measure: Recruitment as Measured by Rates of Enrollment (Aim 1)
timeFrame: At baseline
measure: Retention as Measured by Change in Enrollment
timeFrame: At baseline; at week 11 (post-intervention)
measure: Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1)
timeFrame: At week 11 (post-intervention)
measure: Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1)
timeFrame: At week 11 (post-intervention)
Secondary outcomes:
measure: Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2)
timeFrame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
measure: Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2)
timeFrame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
measure: Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2)
timeFrame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
measure: Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2)
timeFrame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
measure: Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2)
timeFrame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
measure: Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2)
timeFrame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
measure: Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2)
timeFrame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
measure: Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2)
timeFrame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Other outcomes:
measure: Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES)
timeFrame: At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention)
measure: Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE)
timeFrame: At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention)
Locations:
city: New York
country: United States
facility: NewYork-Presbyterian - Weill Cornell Medicine
state: New York
Study officials:
affiliation: Cornell University
name: Anthony Ong, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Cary Reid, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ong AD, Moskowitz JT, Wethington E, Addington EL, Sanni M, Goktas S, Sluys E, Swong S, Kim P, Reid MC. Lessons in Affect Regulation to Keep Stress and Pain UndeR control (LARKSPUR): Design of a randomized controlled trial to increase positive affect in middle-aged and older adults with fibromyalgia. Contemp Clin Trials. 2022 Sep;120:106880. doi: 10.1016/j.cct.2022.106880. Epub 2022 Aug 11.