Positive Affect as a Source of Resilience for Adults in Chronic Pain

NCT04869345 | Completed Results

• 3 other identifiers: 20-060222915P30AG0228455U24AG058556
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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).

Conditions

Geriatric; Chronic Pain

Outcome Measures

Primary Outcomes (4)

• Recruitment as Measured by Rates of Enrollment (Aim 1)

  Percent enrolled of total eligible participants.

  At baseline

• Retention as Measured by Change in Enrollment

  Percentage enrolled at baseline that completed the post-intervention assessment.

  At baseline; at week 11 (post-intervention)

• Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1)

  The feedback survey collected two Likert-scale questions asking whether the participant recommends the intervention: (1) "Would you recommend LARKSPUR to a friend?" and (2) "Would you recommend LARKSPUR to someone else with chronic pain?". Both questions were measured on an 11-point scale, with 0=Definitely Not to 10=Definitely Yes. Higher scores indicate better outcomes for both questions. The two items were analyzed separately, not combined.

  At week 11 (post-intervention)

• Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1)

  Length of Intervention time as measured by number of weeks the participant took to complete the LARKSPUR intervention program.

  At week 11 (post-intervention)

Secondary Outcomes (8)

• Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2)

  At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)

• Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2)

  At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)

• Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2)

  At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)

• Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2)

  At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)

• Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2)

  At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)

Other Outcomes (2)

• Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES)

  At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention)

• Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE)

  At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention)

Study Arms (2)

LARKSPUR intervention

EXPERIMENTAL

Lessons in Affect Regulation to Keep Stress and Pain UndeR control

Behavioral: LARKSPUR

Attention Control Condition

NO INTERVENTION

Daily emotion reporting/no intervention

Interventions

LARKSPUR BEHAVIORAL

This intervention used in our prior research consists of skills training exercises designed to increase the frequency of positive affect. The 6 week intervention (5 weeks of content plus one week of home practice) consists of five components: (1) Positive events and gratitude; (2) mindfulness; (3) reappraisal; (4) strength and goals; and(5) acts of kindness. Participants will have up to 8 weeks to complete this intervention.

LARKSPUR intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment
• Current behavioral treatment for pain
• Enrolled in another pain study

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute on Aging (NIA): collaborator
• Cornell University: collaborator
• Wake Forest University: collaborator

Study Sites (1)

NewYork-Presbyterian - Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (3)

• 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.

  PMID: 35964867 BACKGROUND

• Ong A, Wilcox K, Reid MC, Wethington E, Cintron D, Addington E, Goktas S, Moskowitz J. Targeting Daily Positive Events to Improve Emotional and Functional Well-Being in Adults With Fibromyalgia: Insights From the LARKSPUR Randomized Controlled Trial. J Med Internet Res. 2024 Dec 10;26:e54678. doi: 10.2196/54678.

  PMID: 39657168 DERIVED

• Ong AD, Wilcox KT, Moskowitz JT, Wethington E, Addington EL, Sanni MO, Kim P, Reid MC. Feasibility, Acceptability, and Preliminary Efficacy of a Positive Affect Skills Intervention for Adults With Fibromyalgia. Innov Aging. 2023 Jul 13;7(10):igad070. doi: 10.1093/geroni/igad070. eCollection 2023.

  PMID: 38094931 DERIVED

Related Links

• This manuscript describes the study design and anticipated analyses for this trial.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Anthony Ong
• Organization: Cornell University

anthony.ong@cornell.edu

6072559993

Study Officials

• Anthony Ong, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

• Cary Reid, MD PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: May 3, 2021
• Study Start: July 27, 2021
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: May 1, 2023
• Results First Posted: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

US (1)