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

Chronic Pain Clinical Trial

— LARKSPUR  

Official title:

Feasibility of a Positive Affect Skills Intervention for Reducing Racial Disparities in Pain Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04869345
• Other study ID #: 20-06022291
• Secondary ID: 5P30AG0228455U24
• Status: Completed
• Phase: N/A
• Start date: July 27, 2021
• Est. completion date: June 9, 2022

Study information

• Verified date: April 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Geriatric

Intervention

Behavioral:
• LARKSPUR
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.

Locations

Country	Name	City	State
United States	NewYork-Presbyterian - Weill Cornell Medicine	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Cornell University, National Institute on Aging (NIA), Wake Forest University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES)	Positive affective reactivity measured by the modified Differential Emotions Scale (mDES). Upon completion of each study assessment, participants completed the mDES daily for one week, for a total of three 7-day-long periods. The mDES is a 20-item instrument that measures the extent to which a patient has experienced positive (10 items) and negative (10 items) emotions over a chosen time frame; in the version used in this survey, we ask for emotions over the past 24 hours. Respondents are asked to report the greatest amount of positive affect on a five-point scale: 0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely. mDES mean scores were computed over the 10 items, ranging from 0 (not at all positive) to 4 (extremely positive).	At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention)
Other	Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE)	Affective reactivity to stress measured by the Daily Inventory of Stressful Events (DISE). Upon completion of each study assessment, patients completed the DISE daily for one week, for a total of three 7-day-long periods. The DISE is a 7-item self-report instrument in which participants report whether stressful events (argument, work or school stress, home stress, discrimination, close friend stress, other stressors) have occurred within the past 24 hours, indicating "yes" or "no" accordingly for each item. Item scores are averaged, ranging from 0=no stress to 1=highest stress. Higher scores indicate worse outcomes.	At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention)
Primary	Recruitment as Measured by Rates of Enrollment (Aim 1)	Percent enrolled of total eligible participants.	At baseline
Primary	Retention as Measured by Change in Enrollment	Percentage enrolled at baseline that completed the post-intervention assessment.	At baseline; at week 11 (post-intervention)
Primary	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)
Primary	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	Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2)	Pain intensity T-scores measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. The first two items assess pain intensity over a 7-day recall period; the last item asks patients to rate their pain intensity "right now." Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 36.3 to 81.8. Lower T-scores represent better outcomes.	At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Secondary	Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2)	Pain interference T-scores measured by PROMIS Pain Interference - Short Form 6b. This 6-item instrument measures self-reported impact of pain on a person's life and extent that pain may interfere with engagement with social, cognitive, emotional, physical, and recreational activities over a 7-day recall period. Respondents report pain interference on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, and 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 41.0 to 78.3. Lower T-scores represent better outcomes.	At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Secondary	Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2)	Physical function T-scores measured by PROMIS Physical Function Short Form 10a. This 10-item instrument assesses a patient's abilities and limitations with respect to everyday physical activities. Respondents report limitations on a 5-point scale: 5=Not at all, ..., 3=Somewhat, ..., 1=Cannot do, and abilities to perform activities on a 5-point scale: 5=Without any difficulty, ..., 3=With some difficulty, ..., 1=Unable to do. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 13.5 to 61.9. Higher T-scores represent better outcomes.	At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Secondary	Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2)	Fatigue T-scores measured by PROMIS Fatigue Short Form 6a. This 6-item instrument assesses a patient's a patient's level of fatigue over a 7-day recall period. Respondents report fatigue on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33.4 to 76.8. Lower T-scores represent better outcomes.	At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Secondary	Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2)	The 10-item version of the Center for Epidemiological Studies Depression Scale (CES-D) asks for participants to rate how often over the past week they experienced symptoms associated with depression on a 4-point scale: 0=Rarely or None of the time, 1=Some or Little of the time, 2=Moderately or Much of the time, 3=Most or Almost all the time. CESD-R-10 mean scores range from 0 (rare depressive symptoms) to 4 (depressive symptoms most or almost all the time).	At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Secondary	Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2)	The modified Differential Emotions Scale (mDES) is a 20-item instrument that measures the extent to which a patient has experienced positive and negative emotions over a chosen time frame; in the version used in this study, we ask for emotions over the past 7 days. Respondents are asked to report the greatest amount of a given emotion on a five-point scale: 0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely. mDES mean scores range from 0 (not at all experienced positive emotion) to 4 (extremely positive emotion).	At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Secondary	Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2)	The 20-item self-report Positive and Negative Affect Scale (PANAS-GEN) asks participants to describe to what extent they feel different feelings and emotions on average. Respondents answer on a five-point scale: 0=Very slightly or not at all, 1=A little, 2=Moderately, 3=Quite a bit, 4=Extremely. PANAS-GEN mean scores range from 0 (very slightly or not at all positive affect) to 4 (extremely positive affect).	At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Secondary	Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2)	The 10-item version of the Perceived Stress Scale (PSS) assesses the perception of stress over the previous month. Respondents report how often they have experienced perceived stress on a five-point scale: 0=Never, 1=Almost never, 2=Sometimes, 3=Fairly often, 4=Very often. PSS mean scores range from 0 (experienced no or minimal stress) to 4 (experienced very frequent stress).	At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)

External Links

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