Chronic PainLARKSPURNCT03699553

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

A study testing LARKSPUR; Online Positive Emotions Skills for Individuals with Chronic Musculoskeletal Pain in people with Chronic Pain and Musculoskeletal Pain, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain, Musculoskeletal Pain
What is being tested?: LARKSPUR; Online Positive Emotions Skills for Individuals with Chronic Musculoskeletal Pain
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 15 Oct 2018to 31 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Osher Center for Integrative Medicine
Chicago, Illinois, 60611

Other trials in United States

About this study

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

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.

Conditions: Chronic Pain, Musculoskeletal Pain
Being tested: LARKSPUR; Online Positive Emotions Skills for Individuals with Chronic Musculoskeletal Pain, Emotion Reporting Control Group
Keywords: online intervention, chronic pain, positive emotion, affective science
Medical subject headings: Chronic Pain, Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LARKSPUR; Online Positive Emotions Skills for Individuals with Chronic Musculoskeletal PainBehavioural
8 positive emotion skills taught over 5-6 weeks to help individuals cope with chronic pain and stress.
Emotion Reporting Control GroupBehavioural
Attention matched control condition, participants will report their daily emotions over 5-6 weeks online.

Study groups in NCT03699553
Study group	Role	What they receive
Intervention	Experimental	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). Receives: Behavioral: LARKSPUR; Online Positive Emotions Skills for Individuals with Chronic Musculoskeletal Pain
Emotion Reporting Control	Active comparator	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. Receives: Behavioral: Emotion Reporting Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 12 weeks; from baseline to 12 weeks post baseline

Secondary outcomes (45)

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?"
Measured: 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?"
Measured: 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?"
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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."
Measured: Administered at 12 weeks post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201831 Dec 2022

First posted9 Oct 2018
Study start15 Oct 2018
Primary completion31 Dec 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 40 participants will be randomized to the LARKSPUR Study. 20 will receive the online intervention and 20 will report their daily emotions for the same duration as the intervention. The 20 individuals assigned to the emotion reporting (control group) arm will receive the online intervention after completing the final assessment, 12 weeks after baseline.
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03699553
Sponsor's protocol ID: SP0042991
Acronym: LARKSPUR
Status last verified: Jan 2023
First submitted: 19 Jul 2018
Last updated: 26 Jan 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Positive Affect Regulation as Adjuvant to Integrative Therapies for Chronic Pain: Development of the LARKSPUR Clinic-Based Intervention
ClinicalTrials.gov ID: NCT03699553
Acronym / sponsor ID: LARKSPUR / SP0042991
Conditions: Chronic Pain, Musculoskeletal Pain
Keywords: online intervention, chronic pain, positive emotion, affective science
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: BraveNet
Study start: 15 Oct 2018 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 9 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: 40 participants will be randomized to the LARKSPUR Study. 20 will receive the online intervention and 20 will report their daily emotions for the same duration as the intervention. The 20 individuals assigned to the emotion reporting (control group) arm will receive the online intervention after completing the final assessment, 12 weeks after baseline.

Arm	Type	Receives
Intervention	Experimental	Behavioral: LARKSPUR; Online Positive Emotions Skills for Individuals with Chronic Musculoskeletal PainParticipants 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).
Emotion Reporting Control	Active comparator	Behavioral: Emotion Reporting Control GroupParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LARKSPUR; Online Positive Emotions Skills for Individuals with Chronic Musculoskeletal Pain8 positive emotion skills taught over 5-6 weeks to help individuals cope with chronic pain and stress.	Behavioural	Intervention
Emotion Reporting Control GroupAttention matched control condition, participants will report their daily emotions over 5-6 weeks online.	Behavioural	Emotion Reporting Control

Primary outcome

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
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

45 secondary outcomes

Self-Reported Medication use at baseline
Time frame: Administered at baseline
Self-Reported Medication use at 8 weeks post baseline
Time frame: Administered at 8 weeks post baseline
Self-Reported Medication use at 12 weeks post baseline
Time frame: Administered at 12 weeks post baseline
Modified Differential Emotions Scale (mDES)
Time frame: Administered daily for 5 weeks of the intervention period
Daily Inventory of Stressful Events (DISE)
Time frame: Administered daily for 5 weeks of the intervention period
Pain Level, measured by a single-item pain question
Time frame: Administered daily for 5 weeks of the intervention period
Positive Affect using the NIH Toolbox for Positive Affect, Short-Form (Baseline)
Time frame: Administered at baseline
Positive Affect using the NIH Toolbox for Positive Affect, Short-Form (8 weeks post baseline)
Time frame: Administered at 8 weeks post baseline
Positive Affect using the NIH Toolbox for Positive Affect, Short-Form (12 weeks post baseline)
Time frame: Administered at 12 weeks post baseline
Emotional Support at baseline using the NIH Toolbox for Emotional Support
Time frame: Administered at baseline
Emotional Support at 8 weeks post baseline using the NIH Toolbox for Emotional Support
Time frame: Administered at 8 weeks post baseline
Emotional Support at 12 weeks post baseline using the NIH Toolbox for Emotional Support
Time frame: Administered at 12 weeks post baseline
Physical Function at Baseline through the PROMIS measure for physical function
Time frame: Administered at baseline
Physical Function at 8 weeks post baseline through the PROMIS measure for physical function
Time frame: Administered at 8 weeks post baseline
Physical Function at 12 weeks post baseline through the PROMIS measure for physical function
Time frame: Administered at 12 weeks post baseline
Pain on average over 7 days at baseline through a single-item question
Time frame: Administered at baseline
Pain on average over 7 days at 8 weeks post baseline through a single-item question
Time frame: Administered at 8 weeks post baseline
Pain on average over 7 days at 12 weeks post baseline through a single-item question
Time frame: Administered at 12 weeks post baseline
Depression at baseline using the PROMIS measure
Time frame: Administered at baseline
Depression at 8 weeks post baseline using the PROMIS measure
Time frame: Administered at 8 weeks post baseline
Depression at 12 weeks post baseline using the PROMIS measure
Time frame: Administered at 12 weeks post baseline
Anxiety at baseline using the PROMIS measure
Time frame: Administered at baseline
Anxiety at 8 weeks post baseline using the PROMIS measure
Time frame: Administered at 8 weeks post baseline
Anxiety at 12 weeks post baseline using the PROMIS measure
Time frame: Administered at 12 weeks post baseline
Pain Intensity at baseline using the PROMIS measure
Time frame: Administered at baseline
Pain Intensity at 8 weeks post baseline using the PROMIS measure
Time frame: Administered at 8 weeks post baseline
Pain Intensity at 12 weeks post baseline using the PROMIS measure
Time frame: Administered at 12 weeks post baseline
Pain interference at baseline using the PROMIS measure
Time frame: Administered at baseline
Pain interference at 8 weeks post baseline using the PROMIS measure
Time frame: Administered at 8 weeks post baseline
Pain interference at 12 weeks post baseline using the PROMIS measure
Time frame: Administered at 12 weeks post baseline
Pain Self Efficacy at baseline (PSEQ)
Time frame: Administered at baseline
Pain Self Efficacy at 8 weeks post baseline (PSEQ)
Time frame: Administered at 8 weeks post baseline
Pain Self Efficacy at 12 weeks post baseline (PSEQ)
Time frame: Administered at 12 weeks post baseline
Pain resilience at baseline
Time frame: Administered at baseline
Pain resilience at 8 weeks post baseline
Time frame: Administered at 8 weeks post baseline
Pain resilience at 12 weeks post baseline
Time frame: Administered at 12 weeks post baseline
Pain catastrophizing at baseline
Time frame: Administered at baseline
Pain catastrophizing at 8 weeks post baseline
Time frame: Administered at 8 weeks post baseline
Pain catastrophizing at 12 weeks post baseline
Time frame: Administered at 12 weeks post baseline
Patient adherence at baseline
Time frame: Administered at baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention to the LARKSPUR Study from baseline to 8 weeks post baseline (time frame: 8 weeks; from baseline to 8 weeks post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03699553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.