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

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ClinicalTrials.gov Identifier: NCT04869345
Recruitment Status : Completed
First Posted : May 3, 2021
Last Update Posted : August 2, 2022
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Cornell University
Wake Forest University
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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).


Condition or disease Intervention/treatment Phase
Geriatric Chronic Pain Behavioral: LARKSPUR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of a Positive Affect Skills Intervention for Reducing Racial Disparities in Pain Management
Actual Study Start Date : July 27, 2021
Actual Primary Completion Date : June 9, 2022
Actual Study Completion Date : June 9, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: LARKSPUR intervention
Lessons in Affect Regulation to Keep Stress and Pain UndeR control
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.

No Intervention: Attention Control Condition
Daily emotion reporting/no intervention



Primary Outcome Measures :
  1. Recruitment as Measured by Rates of Enrollment (Aim 1) [ Time Frame: At baseline ]
    Percent enrolled of total eligible participants.

  2. Retention as Measured by Change in Enrollment [ Time Frame: At baseline; at week 11 (post-intervention) ]
    Percentage enrolled at baseline that completed the post-intervention assessment.

  3. Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1) [ Time Frame: At week 11 (post-intervention) ]
    The feedback survey will collect open-ended qualitative information assessing perceived helpfulness, satisfaction, usability, readability, and intervention impact. In addition, two Likert scale questions asking whether the participant recommends the intervention (for friends and for those with pain) will be asked on an 11-point scale, with 0=Definitely Not to 10=Definitely Yes

  4. Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1) [ Time Frame: At week 11 (post-intervention) ]
    Length of Intervention time as measured by number of weeks the participant took to complete the LARKSPUR intervention program.


Secondary Outcome Measures :
  1. Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) [ Time Frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) ]
    Pain intensity will be 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 utilizing a 7-day recall period (items include the phrase "the past 7 days") while 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, and 5=Very severe.

  2. Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) [ Time Frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) ]
    Pain interference will be measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference - Short Form 6b. This 6-item instrument measures the self-reported impact of pain on a person's life and assesses the extent to which pain may interfere with engagement with social, cognitive, emotional, physical, and recreational activities over a 7-day recall period. Pain Interference also incorporates items probing sleep and enjoyment in life, though the item bank only contains one sleep item. Respondents report levels of 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.

  3. Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2) [ Time Frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) ]
    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.

  4. Change in Positive Affect as Measured by the modified Differential Emotions Scale (mDES) (Aim 2) [ Time Frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) ]
    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.

  5. Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2) [ Time Frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) ]
    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: 1=Very slightly or not at all, 2=A little, 3=Moderately, 4=Quite a bit, 5=Extremely.

  6. Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) [ Time Frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) ]
    The PROMIS Physical Function Short Form 10a is a 10-item instrument that assesses a patient's abilities and limitations with respect to everyday physical activities, such as climbing the stairs, carrying groceries, and being able to sit on and get up from the toilet. Respondents are asked to report limitations on a five-point scale: 5=Not at all, 4=Very little, 3=Somewhat, 2=Quite a lot, 1=Cannot do. They are then asked to report their abilities to perform activities on a five-point scale: 5=Without any difficulty, 4=With a little difficulty, 3=With some difficulty, 2=With much difficulty, 1=Unable to do.

  7. Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) [ Time Frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) ]
    The PROMIS Fatigue - Short Form 6a is a 6-item instrument that assesses a patient's level of fatigue over a 7-day recall period. Respondents are asked to report fatigue on a scale on a five-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much.

  8. Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) [ Time Frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) ]
    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: 1=Never, 2=Almost never, 3=Sometimes, 4=Fairly often, 5=Very often.


Other Outcome Measures:
  1. Change in Affective Reactivity to Stress as Measured by the daily modified Differential Emotions Scale (mDES) [ Time Frame: At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention) ]
    Upon completion of each study assessment, the participant will complete one week of daily surveys, for a total of three 7-day-long periods. These daily surveys will collect data on affective reactivity to stress and will be used in a post-hoc exploratory analysis. The instrument used will be the modified Differential Emotions Scale (mDES), 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 survey, we ask for emotions over the past 24 hours. 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.

  2. Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE) [ Time Frame: At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention) ]
    Upon completion of each study assessment, the participant will complete one week of daily surveys, for a total of three 7-day-long periods. These daily surveys will collect data on affective reactivity to stress and will be used in a post-hoc exploratory analysis. The instrument used will be the Daily Inventory of Stressful Events (DISE), a 7-item self-report instrument in which participants report whether stressful events have occurred within the past 24 hours, indicating "yes" or "no" accordingly.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04869345


Locations
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United States, New York
NewYork-Presbyterian - Weill Cornell Medicine
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Cornell University
Wake Forest University
Investigators
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Principal Investigator: Anthony Ong, PhD Cornell University
Principal Investigator: Cary Reid, MD PhD Weill Medical College of Cornell University
  Study Documents (Full-Text)

Documents provided by Weill Medical College of Cornell University:
Informed Consent Form  [PDF] October 13, 2021

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04869345    
Other Study ID Numbers: 20-06022291
5P30AG022845 ( U.S. NIH Grant/Contract )
5U24AG058556 ( U.S. NIH Grant/Contract )
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Reduced, de-identified data sets containing data collected from patients, will be made available for secondary use at the National Archive of Computerized Data on Aging (NACDA), a division of ICPSR at the University of Michigan. NACDA is a repository of survey data on aging that has hundreds of social science research data sets available that are drawn from NIA-funded surveys and data collection efforts. NACDA has established protocols for contributors to reliably de-identify survey participants, regardless of whether they have been assembled as part of national random sample surveys or specialized registry data collection efforts. External users may be asked to provide study aims, variables requested, analytic plans, and targeted journals in their data use requests. They will also be asked to not attempt to re-identify participants, either by merging in administrative, census, medical, or other data, or by using a software program that might re-identify participants.
Supporting Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations