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Completed

NCT Number: NCT03699553

Lessons in Affect Regulation to Keep Stress and Pain UndeR Control (LARKSPUR R34)

Chronic pain affects millions of Americans but integrative as well as conventional treatments fall short in terms of alleviating this pain. The investigators are testing a tailored online positive affect skills intervention through a high-quality, randomized controlled trial for people with chronic musculoskeletal pain. The proposed work holds promise as an effective, low cost, easily disseminated intervention to help people cope with chronic pain, decrease depression and distress that pose barriers to optimal adherence, and potentially boost the efficacy of integrative as well as conventional pain treatments.

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Key information

Conditions

Chronic Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osher Center for Integrative Medicine

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and over
  • Current patient at Northwestern Memorial Hospital
  • Seeking treatment for chronic musculoskeletal pain at the Northwestern Osher Center for Integrative Medicine. Pain will be defined as persisting for at least the past three months with an average level over the past month of at least 4 of 10 on a numerical rating scale, including back pain, neck pain/cervicalgia, knee pain, other joint pain (hips, ankles), fibromyalgia, osteoarthritis and rheumatoid arthritis.
  • Fluent in the English language
  • Have a working email address
  • Have reliable Internet access in order to access the website online

Treatment and study plan

LARKSPUR; Online Positive Emotions Skills for Individuals with Chronic Musculoskeletal Pain

Behavioral

8 positive emotion skills taught over 5-6 weeks to help individuals cope with chronic pain and stress.

Emotion Reporting Control Group

Behavioral

Attention matched control condition, participants will report their daily emotions over 5-6 weeks online.

Primary outcomes

  1. Retention to the LARKSPUR Study from baseline to 8 weeks post baseline

    Time frame: 8 weeks; from baseline to 8 weeks post baseline

    Retention will be defined as responding to the assessments at baseline and at 8 weeks post baseline

  2. Retention to the LARKSPUR Study from baseline to 12 weeks post baseline

    Time frame: 12 weeks; from baseline to 12 weeks post baseline

    Retention will be defined as responding to the assessments at baseline and at 12 weeks post baseline

Secondary outcomes

  1. Self-Reported Medication use at baseline

    Time frame: Administered at baseline

    Measuring medication use by asking: "Have you used any prescription or non-prescription medication for your pain in the last 7 days?" with a Yes-No response. If "Yes" is selected, options include 13 types of medications as response options, with 2 follow-up question for each medication selected: "How many milligrams (mg) per pill, if you know it?" and "What is the average number of pills per day?"

  2. Self-Reported Medication use at 8 weeks post baseline

    Time frame: Administered at 8 weeks post baseline

    Measuring medication use by asking: "Have you used any prescription or non-prescription medication for your pain in the last 7 days?" with a Yes-No response. If "Yes" is selected, options include 13 types of medications as response options, with 2 follow-up question for each medication selected: "How many milligrams (mg) per pill, if you know it?" and "What is the average number of pills per day?"

  3. Self-Reported Medication use at 12 weeks post baseline

    Time frame: Administered at 12 weeks post baseline

    Measuring medication use by asking: "Have you used any prescription or non-prescription medication for your pain in the last 7 days?" with a Yes-No response. If "Yes" is selected, options include 13 types of medications as response options, with 2 follow-up question for each medication selected: "How many milligrams (mg) per pill, if you know it?" and "What is the average number of pills per day?"

  4. Modified Differential Emotions Scale (mDES)

    Time frame: Administered daily for 5 weeks of the intervention period

    Measuring positive and negative affect through a 26-item modified version of the Differential Emotions Scale with the anchor: "How much have you felt each of these emotions over the PAST DAY?" with items including "amused or fun-loving" "angry, irritated, or frustrated" and "anxious or scared." Response scale is from 1 Not at all to 9 All the time.

  5. Daily Inventory of Stressful Events (DISE)

    Time frame: Administered daily for 5 weeks of the intervention period

    Measuring stress through a 7-item scale with the following anchor: "Over the PAST DAY, have you…" and the items include: "Had an argument or disagreement with someone?" and "Almost had an argument or disagreement but decided to let it pass to avoid disagreement?" The response scale is from 0 Didn't happen to 4 Very Stressful.

  6. Pain Level, measured by a single-item pain question

    Time frame: Administered daily for 5 weeks of the intervention period

    Measuring daily pain level through the single-item: "What is your level of pain right now?" Response items range from 0 No Pain to 10 Pain as bad as you can imagine.

  7. Positive Affect using the NIH Toolbox for Positive Affect, Short-Form (Baseline)

    Time frame: Administered at baseline

    A 16-item measure that asks: "In the past 7 days…" and there are 15 items such as "I felt cheerful" "I felt attentive" "I felt delighted" "I felt happy." The response scale ranges from 1 Not at all to 5 Very much.

  8. Positive Affect using the NIH Toolbox for Positive Affect, Short-Form (8 weeks post baseline)

    Time frame: Administered at 8 weeks post baseline

    A 16-item measure that asks: "In the past 7 days…" and there are 15 items such as "I felt cheerful" "I felt attentive" "I felt delighted" "I felt happy." The response scale ranges from 1 Not at all to 5 Very much.

  9. Positive Affect using the NIH Toolbox for Positive Affect, Short-Form (12 weeks post baseline)

    Time frame: Administered at 12 weeks post baseline

    A 16-item measure that asks: "In the past 7 days…" and there are 15 items such as "I felt cheerful" "I felt attentive" "I felt delighted" "I felt happy." The response scale ranges from 1 Not at all to 5 Very much.

  10. Emotional Support at baseline using the NIH Toolbox for Emotional Support

    Time frame: Administered at baseline

    Measuring emotional support through the 4-item NIH Toolbox measure for emotional support (4a) with questions such as "I have someone who will listen to me when I need to talk" and "I have someone to confide in or talk about myself or my problems." The response is on a 5-point scale from Never to Always.

  11. Emotional Support at 8 weeks post baseline using the NIH Toolbox for Emotional Support

    Time frame: Administered at 8 weeks post baseline

    Measuring emotional support through the 4-item NIH Toolbox measure for emotional support (4a) with questions such as "I have someone who will listen to me when I need to talk" and "I have someone to confide in or talk about myself or my problems." The response is on a 5-point scale from Never to Always.

  12. Emotional Support at 12 weeks post baseline using the NIH Toolbox for Emotional Support

    Time frame: Administered at 12 weeks post baseline

    Measuring emotional support through the 4-item NIH Toolbox measure for emotional support (4a) with questions such as "I have someone who will listen to me when I need to talk" and "I have someone to confide in or talk about myself or my problems." The response is on a 5-point scale from Never to Always.

  13. Physical Function at Baseline through the PROMIS measure for physical function

    Time frame: Administered at baseline

    Measuring physical function through the 4-item PROMIS Short-From v2.0 - Physical Function 4a. Questions include: "Are you able to do chores such as vacuuming or yard work?" or "Are you able to go up and down stairs at a normal pace?" Responses are on a 5-point scale from "Without any difficulty" to "Unable to do."

  14. Physical Function at 8 weeks post baseline through the PROMIS measure for physical function

    Time frame: Administered at 8 weeks post baseline

    Measuring physical function through the 4-item PROMIS Short-From v2.0 - Physical Function 4a. Questions include: "Are you able to do chores such as vacuuming or yard work?" or "Are you able to go up and down stairs at a normal pace?" Responses are on a 5-point scale from "Without any difficulty" to "Unable to do."

  15. Physical Function at 12 weeks post baseline through the PROMIS measure for physical function

    Time frame: Administered at 12 weeks post baseline

    Measuring physical function through the 4-item PROMIS Short-From v2.0 - Physical Function 4a. Questions include: "Are you able to do chores such as vacuuming or yard work?" or "Are you able to go up and down stairs at a normal pace?" Responses are on a 5-point scale from "Without any difficulty" to "Unable to do."

  16. Pain on average over 7 days at baseline through a single-item question

    Time frame: Administered at baseline

    Measuring pain on average over the past 7 days with a single-item question: "In the past 7 days, how would you rate your pain on average?" The response scale ranges from 0 No pain to 10 Pain as bad as you can imagine.

  17. Pain on average over 7 days at 8 weeks post baseline through a single-item question

    Time frame: Administered at 8 weeks post baseline

    Measuring pain on average over the past 7 days with a single-item question: "In the past 7 days, how would you rate your pain on average?" The response scale ranges from 0 No pain to 10 Pain as bad as you can imagine.

  18. Pain on average over 7 days at 12 weeks post baseline through a single-item question

    Time frame: Administered at 12 weeks post baseline

    Measuring pain on average over the past 7 days with a single-item question: "In the past 7 days, how would you rate your pain on average?" The response scale ranges from 0 No pain to 10 Pain as bad as you can imagine.

  19. Depression at baseline using the PROMIS measure

    Time frame: Administered at baseline

    Measuring depression using the PROMIS Short-Form v1.0-Depression 4a with 4 items including: "In the past 7 days I felt worthless" and "In the past 7 days I felt helpless." The 5-point response scale ranges from Never to Always.

  20. Depression at 8 weeks post baseline using the PROMIS measure

    Time frame: Administered at 8 weeks post baseline

    Measuring depression using the PROMIS Short-Form v1.0-Depression 4a with 4 items including: "In the past 7 days I felt worthless" and "In the past 7 days I felt helpless." The 5-point response scale ranges from Never to Always.

  21. Depression at 12 weeks post baseline using the PROMIS measure

    Time frame: Administered at 12 weeks post baseline

    Measuring depression using the PROMIS Short-Form v1.0-Depression 4a with 4 items including: "In the past 7 days I felt worthless" and "In the past 7 days I felt helpless." The 5-point response scale ranges from Never to Always.

  22. Anxiety at baseline using the PROMIS measure

    Time frame: Administered at baseline

    Measuring anxiety using the PROMIS Short-Form v1.0-Anxiety 4a with 4 items such as "In the past 7 days I felt fearful" and "In the past 7 days I found it hard to focus on anything other than my anxiety." The 5-point response scale ranges from Never to Always.

  23. Anxiety at 8 weeks post baseline using the PROMIS measure

    Time frame: Administered at 8 weeks post baseline

    Measuring anxiety using the PROMIS Short-Form v1.0-Anxiety 4a with 4 items such as "In the past 7 days I felt fearful" and "In the past 7 days I found it hard to focus on anything other than my anxiety." The 5-point response scale ranges from Never to Always.

  24. Anxiety at 12 weeks post baseline using the PROMIS measure

    Time frame: Administered at 12 weeks post baseline

    Measuring anxiety using the PROMIS Short-Form v1.0-Anxiety 4a with 4 items such as "In the past 7 days I felt fearful" and "In the past 7 days I found it hard to focus on anything other than my anxiety." The 5-point response scale ranges from Never to Always.

  25. Pain Intensity at baseline using the PROMIS measure

    Time frame: Administered at baseline

    Measuring pain intensity using the PROMIS Scale v.1.0- Pain Intensity 3a which consists of 3 questions with the anchor: "In the past 7 days…" and the items include "How intense was your pain at its worst?" "How intense was your average pain?" and "What is your level of pain right now?" The 5-item response scale ranges from "Had no pain" to "Very severe."

  26. Pain Intensity at 8 weeks post baseline using the PROMIS measure

    Time frame: Administered at 8 weeks post baseline

    Measuring pain intensity using the PROMIS Scale v.1.0- Pain Intensity 3a which consists of 3 questions with the anchor: "In the past 7 days…" and the items include "How intense was your pain at its worst?" "How intense was your average pain?" and "What is your level of pain right now?" The 5-item response scale ranges from "Had no pain" to "Very severe."

  27. Pain Intensity at 12 weeks post baseline using the PROMIS measure

    Time frame: Administered at 12 weeks post baseline

    Measuring pain intensity using the PROMIS Scale v.1.0- Pain Intensity 3a which consists of 3 questions with the anchor: "In the past 7 days…" and the items include "How intense was your pain at its worst?" "How intense was your average pain?" and "What is your level of pain right now?" The 5-item response scale ranges from "Had no pain" to "Very severe."

  28. Pain interference at baseline using the PROMIS measure

    Time frame: Administered at baseline

    Measuring pain interference using the PROMIS SF v1.0 - pain Interference 8a with the anchor: "In the past 7 days…" with 8 items including: "How much did pain interfere with your day to day activities?" "How much did pain interfere with work around the home?" or "How much did pain interfere with your ability to participate in social activities?" The 5-item response scale ranges from "Not at all" to "Very much."

  29. Pain interference at 8 weeks post baseline using the PROMIS measure

    Time frame: Administered at 8 weeks post baseline

    Measuring pain interference using the PROMIS SF v1.0 - pain Interference 8a with the anchor: "In the past 7 days…" with 8 items including: "How much did pain interfere with your day to day activities?" "How much did pain interfere with work around the home?" or "How much did pain interfere with your ability to participate in social activities?" The 5-item response scale ranges from "Not at all" to "Very much."

  30. Pain interference at 12 weeks post baseline using the PROMIS measure

    Time frame: Administered at 12 weeks post baseline

    Measuring pain interference using the PROMIS SF v1.0 - pain Interference 8a with the anchor: "In the past 7 days…" with 8 items including: "How much did pain interfere with your day to day activities?" "How much did pain interfere with work around the home?" or "How much did pain interfere with your ability to participate in social activities?" The 5-item response scale ranges from "Not at all" to "Very much."

  31. Pain Self Efficacy at baseline (PSEQ)

    Time frame: Administered at baseline

    Measuring pain self efficacy using the Pain Self Efficacy Questionnaire (PSEQ) which has 10 items with the anchor: "Please rate how confident you are that you can do the following things at present, despite the pain." Items include: "I can enjoy things, despite the pain." "I can cope with my pain in most situations." "I can cope with my pain without medication." The response scale ranges from 0 Not at all Confident to 6 Completely Confident.

  32. Pain Self Efficacy at 8 weeks post baseline (PSEQ)

    Time frame: Administered at 8 weeks post baseline

    Measuring pain self efficacy using the Pain Self Efficacy Questionnaire (PSEQ) which has 10 items with the anchor: "Please rate how confident you are that you can do the following things at present, despite the pain." Items include: "I can enjoy things, despite the pain." "I can cope with my pain in most situations." "I can cope with my pain without medication." The response scale ranges from 0 Not at all Confident to 6 Completely Confident.

  33. Pain Self Efficacy at 12 weeks post baseline (PSEQ)

    Time frame: Administered at 12 weeks post baseline

    Measuring pain self efficacy using the Pain Self Efficacy Questionnaire (PSEQ) which has 10 items with the anchor: "Please rate how confident you are that you can do the following things at present, despite the pain." Items include: "I can enjoy things, despite the pain." "I can cope with my pain in most situations." "I can cope with my pain without medication." The response scale ranges from 0 Not at all Confident to 6 Completely Confident.

  34. Pain resilience at baseline

    Time frame: Administered at baseline

    Measuring pain resilience using the 14 item Pain Resilience Scale. The anchor is: "When faced with intense or prolonged pain…" Items include "I get back out there" "I push through it" "I keep a positive attitude" and "I try to stay relaxed." The 5-item response scale ranges from "0 Not at all" to "4 All the time."

  35. Pain resilience at 8 weeks post baseline

    Time frame: Administered at 8 weeks post baseline

    Measuring pain resilience using the 14 item Pain Resilience Scale. The anchor is: "When faced with intense or prolonged pain…" Items include "I get back out there" "I push through it" "I keep a positive attitude" and "I try to stay relaxed." The 5-item response scale ranges from "0 Not at all" to "4 All the time."

  36. Pain resilience at 12 weeks post baseline

    Time frame: Administered at 12 weeks post baseline

    Measuring pain resilience using the 14 item Pain Resilience Scale. The anchor is: "When faced with intense or prolonged pain…" Items include "I get back out there" "I push through it" "I keep a positive attitude" and "I try to stay relaxed." The 5-item response scale ranges from "0 Not at all" to "4 All the time."

  37. Pain catastrophizing at baseline

    Time frame: Administered at baseline

    Measuring pain catastrophizing using the Pain Catastrophizing Scale which has 13 items with the anchor: "When I'm in pain…" Items include: "I feel I can't go on." "I feel I can't stand it anymore." "I keep thinking about how much it hurts." The response scale ranges from 0 Not al all to 4 All the Time.

  38. Pain catastrophizing at 8 weeks post baseline

    Time frame: Administered at 8 weeks post baseline

    Measuring pain catastrophizing using the Pain Catastrophizing Scale which has 13 items with the anchor: "When I'm in pain…" Items include: "I feel I can't go on." "I feel I can't stand it anymore." "I keep thinking about how much it hurts." The response scale ranges from 0 Not al all to 4 All the Time.

  39. Pain catastrophizing at 12 weeks post baseline

    Time frame: Administered at 12 weeks post baseline

    Measuring pain catastrophizing using the Pain Catastrophizing Scale which has 13 items with the anchor: "When I'm in pain…" Items include: "I feel I can't go on." "I feel I can't stand it anymore." "I keep thinking about how much it hurts." The response scale ranges from 0 Not al all to 4 All the Time.

  40. Patient adherence at baseline

    Time frame: Administered at baseline

    Measuring patient adherence to medical recommendations using the Medical Outcomes Study (MOS) Measures of Patient Adherence. The instrument has 5 items. The first four items ask questions like "I had a hard time doing what the doctor suggested I do… " or "I was unable to do what was necessary to follow my doctor's treatment plans…." The 5th item asks: "Generally speaking, how often during the past 4 weeks were you able to do what the doctor told you?" The 6-item response scale ranges from None of the time to All of the time.

  41. Patient adherence at 8 weeks post baseline

    Time frame: Administered at 8 weeks post baseline

    Measuring patient adherence to medical recommendations using the Medical Outcomes Study (MOS) Measures of Patient Adherence. The instrument has 5 items. The first four items ask questions like "I had a hard time doing what the doctor suggested I do… " or "I was unable to do what was necessary to follow my doctor's treatment plans…." The 5th item asks: "Generally speaking, how often during the past 4 weeks were you able to do what the doctor told you?" The 6-item response scale ranges from None of the time to All of the time.

  42. Patient adherence at 12 weeks post baseline

    Time frame: Administered at 12 weeks post baseline

    Measuring patient adherence to medical recommendations using the Medical Outcomes Study (MOS) Measures of Patient Adherence. The instrument has 5 items. The first four items ask questions like "I had a hard time doing what the doctor suggested I do… " or "I was unable to do what was necessary to follow my doctor's treatment plans…." The 5th item asks: "Generally speaking, how often during the past 4 weeks were you able to do what the doctor told you?" The 6-item response scale ranges from None of the time to All of the time.

  43. Sleep disturbance at baseline using the PROMIS measure

    Time frame: Administered at baseline

    Measuring sleep disturbance using the 4-item PROMIS Short Form v.1.0 - Sleep Disturbance 4a with the anchor: "In the past 7 days…" Three of the items are: "My sleep was refreshing" "I had a problem with my sleep" and "I had difficulty falling asleep." The 5-item response scale ranges from "Not at all" to "Very much." The fourth question is: "My sleep quality was…" with the 5-item response scale ranging from "Very poor" to "Very good."

  44. Sleep disturbance at 8 weeks post baseline using the PROMIS measure

    Time frame: Administered at 8 weeks post baseline

    Measuring sleep disturbance using the 4-item PROMIS Short Form v.1.0 - Sleep Disturbance 4a with the anchor: "In the past 7 days…" Three of the items are: "My sleep was refreshing" "I had a problem with my sleep" and "I had difficulty falling asleep." The 5-item response scale ranges from "Not at all" to "Very much." The fourth question is: "My sleep quality was…" with the 5-item response scale ranging from "Very poor" to "Very good."

  45. Sleep disturbance at 12 weeks post baseline using the PROMIS measure

    Time frame: Administered at 12 weeks post baseline

    Measuring sleep disturbance using the 4-item PROMIS Short Form v.1.0 - Sleep Disturbance 4a with the anchor: "In the past 7 days…" Three of the items are: "My sleep was refreshing" "I had a problem with my sleep" and "I had difficulty falling asleep." The 5-item response scale ranges from "Not at all" to "Very much." The fourth question is: "My sleep quality was…" with the 5-item response scale ranging from "Very poor" to "Very good."

Other outcomes

  1. Use of prescription medication in the patient's Electronic Health Record at 12 weeks post baseline

    Time frame: EHR data pull at 12 weeks post baseline

    We will look at the patient's medical record from the EHR datapull to cross-reference the self-reported prescription medication use

  2. Use of non-prescription medication in the patient's Electronic Health Record at 12 weeks post baseline

    Time frame: EHR data pull at 12 weeks post baseline

    We will look at the patient's medical record from the EHR datapull to cross-reference the self-reported non-prescription medication use

  3. Results of physical examinations in the patient's Electronic Health Record at 12 weeks post baseline

    Time frame: EHR data pull at 12 weeks post baseline

    We will look at the patient's medical record from the EHR datapull to cross-reference the self-reported pain on average over 7 days at baseline, 8 weeks post baseline, and at 12 weeks post baseline

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • BraveNet

Registry information

Official study title

Positive Affect Regulation as Adjuvant to Integrative Therapies for Chronic Pain: Development of the LARKSPUR Clinic-Based Intervention

Acronym: LARKSPUR

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2018
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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