An interventional study of LARKSPUR; Online Positive Emotions Skills for Individuals with Chronic Musculoskeletal Pain and Emotion Reporting Control Group in Chronic Pain and Musculoskeletal Pain, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's enrollment of 80 is above the median of 60 across 2,209 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Participants will receive the online LARKSPUR intervention which lasts about 5-6 weeks, receiving the positive emotions skills through the website, and logging on to the website for about 5-10 minutes each day for that period. Assessments will be taken at baseline, post-intervention (8 weeks after the baseline), and 12 weeks after baseline (1 month post intervention).
Behavioral: LARKSPUR; Online Positive Emotions Skills for Individuals with Chronic Musculoskeletal Pain
Participants will report their emotions for 5-6 weeks by logging on to the website for about 5 minutes each day. Assessments will be taken at baseline, 8 weeks after baseline, and 12 weeks after baseline. After 12 weeks, participants will receive access to the LARKSPUR intervention online.
Behavioral: Emotion Reporting Control Group
8 positive emotion skills taught over 5-6 weeks to help individuals cope with chronic pain and stress.
Attention matched control condition, participants will report their daily emotions over 5-6 weeks online.
Retention to the LARKSPUR Study from baseline to 8 weeks post baseline
Retention will be defined as responding to the assessments at baseline and at 8 weeks post baseline
Time frame: 8 weeks; from baseline to 8 weeks post baseline
Retention to the LARKSPUR Study from baseline to 12 weeks post baseline
Retention will be defined as responding to the assessments at baseline and at 12 weeks post baseline
Time frame: 12 weeks; from baseline to 12 weeks post baseline
Self-Reported Medication use 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?"
Time frame: Administered at baseline
Self-Reported Medication use 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?"
Time frame: Administered at 8 weeks post baseline
Self-Reported Medication use 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?"
Time frame: Administered at 12 weeks post baseline
Modified Differential Emotions Scale (mDES)
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.
Time frame: Administered daily for 5 weeks of the intervention period
Daily Inventory of Stressful Events (DISE)
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.
Time frame: Administered daily for 5 weeks of the intervention period
Pain Level, measured by a single-item pain question
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.
Time frame: Administered daily for 5 weeks of the intervention period
Positive Affect using the NIH Toolbox for Positive Affect, Short-Form (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.
Time frame: Administered at baseline
Positive Affect using the NIH Toolbox for Positive Affect, Short-Form (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.
Time frame: Administered at 8 weeks post baseline
Positive Affect using the NIH Toolbox for Positive Affect, Short-Form (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.
Time frame: Administered at 12 weeks post baseline
Emotional Support at baseline using the NIH Toolbox for Emotional Support
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.
Time frame: Administered at baseline
Emotional Support at 8 weeks post baseline using the NIH Toolbox for Emotional Support
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.
Time frame: Administered at 8 weeks post baseline
Emotional Support at 12 weeks post baseline using the NIH Toolbox for Emotional Support
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.
Time frame: Administered at 12 weeks post baseline
Physical Function at Baseline through the PROMIS measure for physical function
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."
Time frame: Administered at baseline
Physical Function at 8 weeks post baseline through the PROMIS measure for physical function
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."
Time frame: Administered at 8 weeks post baseline
Physical Function at 12 weeks post baseline through the PROMIS measure for physical function
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."
Time frame: Administered at 12 weeks post baseline
Pain on average over 7 days at baseline through a single-item question
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.
Time frame: Administered at baseline
Pain on average over 7 days at 8 weeks post baseline through a single-item question
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.
Time frame: Administered at 8 weeks post baseline
Pain on average over 7 days at 12 weeks post baseline through a single-item question
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.
Time frame: Administered at 12 weeks post baseline
Depression at baseline using the PROMIS measure
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.
Time frame: Administered at baseline
Depression at 8 weeks post baseline using the PROMIS measure
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.
Time frame: Administered at 8 weeks post baseline
Depression at 12 weeks post baseline using the PROMIS measure
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.
Time frame: Administered at 12 weeks post baseline
Anxiety at baseline using the PROMIS measure
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.
Time frame: Administered at baseline
Anxiety at 8 weeks post baseline using the PROMIS measure
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.
Time frame: Administered at 8 weeks post baseline
Anxiety at 12 weeks post baseline using the PROMIS measure
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.
Time frame: Administered at 12 weeks post baseline
Pain Intensity at baseline using the PROMIS measure
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."
Time frame: Administered at baseline
Pain Intensity at 8 weeks post baseline using the PROMIS measure
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."
Time frame: Administered at 8 weeks post baseline
Pain Intensity at 12 weeks post baseline using the PROMIS measure
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."
Time frame: Administered at 12 weeks post baseline
Pain interference at baseline using the PROMIS measure
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."
Time frame: Administered at baseline
Pain interference at 8 weeks post baseline using the PROMIS measure
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."
Time frame: Administered at 8 weeks post baseline
Pain interference at 12 weeks post baseline using the PROMIS measure
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."
Time frame: Administered at 12 weeks post baseline
Pain Self Efficacy at baseline (PSEQ)
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.
Time frame: Administered at baseline
Pain Self Efficacy at 8 weeks post baseline (PSEQ)
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.
Time frame: Administered at 8 weeks post baseline
Pain Self Efficacy at 12 weeks post baseline (PSEQ)
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.
Time frame: Administered at 12 weeks post baseline
Pain resilience 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."
Time frame: Administered at baseline
Pain resilience 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."
Time frame: Administered at 8 weeks post baseline
Pain resilience 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."
Time frame: Administered at 12 weeks post baseline
Pain catastrophizing 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.
Time frame: Administered at baseline
Pain catastrophizing 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.
Time frame: Administered at 8 weeks post baseline
Pain catastrophizing 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.
Time frame: Administered at 12 weeks post baseline
Patient adherence 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.
Time frame: Administered at baseline
Patient adherence 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.
Time frame: Administered at 8 weeks post baseline
Patient adherence 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.
Time frame: Administered at 12 weeks post baseline
Sleep disturbance at baseline using the PROMIS measure
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."
Time frame: Administered at baseline
Sleep disturbance at 8 weeks post baseline using the PROMIS measure
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."
Time frame: Administered at 8 weeks post baseline
Sleep disturbance at 12 weeks post baseline using the PROMIS measure
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."
Time frame: Administered at 12 weeks post baseline
Use of prescription medication in the patient's Electronic Health Record 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
Time frame: EHR data pull at 12 weeks post baseline
Use of non-prescription medication in the patient's Electronic Health Record 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
Time frame: EHR data pull at 12 weeks post baseline
Results of physical examinations in the patient's Electronic Health Record 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
Time frame: EHR data pull at 12 weeks post baseline
Ran from Oct 2018 to primary completion in Dec 2022, 50 months.
Of 1,209 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 50 months is above that.
Counting every sponsor, half of 1,296 studies reached it within 21 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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