Clinical trial NCT03699553: Lessons in Affect Regulation to Keep Stress and Pain UndeR Control (LARKSPUR R34)
Official title: Positive Affect Regulation as Adjuvant to Integrative Therapies for Chronic Pain: Development of the LARKSPUR Clinic-Based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain
Keywords: online intervention
chronic pain
positive emotion
affective science
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: BraveNet
First posted: 2018-10-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Retention to the LARKSPUR Study from baseline to 8 weeks post baseline
timeFrame: 8 weeks; from baseline to 8 weeks post baseline
measure: Retention to the LARKSPUR Study from baseline to 12 weeks post baseline
timeFrame: 12 weeks; from baseline to 12 weeks post baseline
Secondary outcomes:
measure: Self-Reported Medication use at baseline
timeFrame: Administered at baseline
measure: Self-Reported Medication use at 8 weeks post baseline
timeFrame: Administered at 8 weeks post baseline
measure: Self-Reported Medication use at 12 weeks post baseline
timeFrame: Administered at 12 weeks post baseline
measure: Modified Differential Emotions Scale (mDES)
timeFrame: Administered daily for 5 weeks of the intervention period
measure: Daily Inventory of Stressful Events (DISE)
timeFrame: Administered daily for 5 weeks of the intervention period
measure: Pain Level, measured by a single-item pain question
timeFrame: Administered daily for 5 weeks of the intervention period
measure: Positive Affect using the NIH Toolbox for Positive Affect, Short-Form (Baseline)
timeFrame: Administered at baseline
measure: Positive Affect using the NIH Toolbox for Positive Affect, Short-Form (8 weeks post baseline)
timeFrame: Administered at 8 weeks post baseline
measure: Positive Affect using the NIH Toolbox for Positive Affect, Short-Form (12 weeks post baseline)
timeFrame: Administered at 12 weeks post baseline
measure: Emotional Support at baseline using the NIH Toolbox for Emotional Support
timeFrame: Administered at baseline
measure: Emotional Support at 8 weeks post baseline using the NIH Toolbox for Emotional Support
timeFrame: Administered at 8 weeks post baseline
measure: Emotional Support at 12 weeks post baseline using the NIH Toolbox for Emotional Support
timeFrame: Administered at 12 weeks post baseline
measure: Physical Function at Baseline through the PROMIS measure for physical function
timeFrame: Administered at baseline
measure: Physical Function at 8 weeks post baseline through the PROMIS measure for physical function
timeFrame: Administered at 8 weeks post baseline
measure: Physical Function at 12 weeks post baseline through the PROMIS measure for physical function
timeFrame: Administered at 12 weeks post baseline
measure: Pain on average over 7 days at baseline through a single-item question
timeFrame: Administered at baseline
measure: Pain on average over 7 days at 8 weeks post baseline through a single-item question
timeFrame: Administered at 8 weeks post baseline
measure: Pain on average over 7 days at 12 weeks post baseline through a single-item question
timeFrame: Administered at 12 weeks post baseline
measure: Depression at baseline using the PROMIS measure
timeFrame: Administered at baseline
measure: Depression at 8 weeks post baseline using the PROMIS measure
timeFrame: Administered at 8 weeks post baseline
measure: Depression at 12 weeks post baseline using the PROMIS measure
timeFrame: Administered at 12 weeks post baseline
measure: Anxiety at baseline using the PROMIS measure
timeFrame: Administered at baseline
measure: Anxiety at 8 weeks post baseline using the PROMIS measure
timeFrame: Administered at 8 weeks post baseline
measure: Anxiety at 12 weeks post baseline using the PROMIS measure
timeFrame: Administered at 12 weeks post baseline
measure: Pain Intensity at baseline using the PROMIS measure
timeFrame: Administered at baseline
measure: Pain Intensity at 8 weeks post baseline using the PROMIS measure
timeFrame: Administered at 8 weeks post baseline
measure: Pain Intensity at 12 weeks post baseline using the PROMIS measure
timeFrame: Administered at 12 weeks post baseline
measure: Pain interference at baseline using the PROMIS measure
timeFrame: Administered at baseline
measure: Pain interference at 8 weeks post baseline using the PROMIS measure
timeFrame: Administered at 8 weeks post baseline
measure: Pain interference at 12 weeks post baseline using the PROMIS measure
timeFrame: Administered at 12 weeks post baseline
measure: Pain Self Efficacy at baseline (PSEQ)
timeFrame: Administered at baseline
measure: Pain Self Efficacy at 8 weeks post baseline (PSEQ)
timeFrame: Administered at 8 weeks post baseline
measure: Pain Self Efficacy at 12 weeks post baseline (PSEQ)
timeFrame: Administered at 12 weeks post baseline
measure: Pain resilience at baseline
timeFrame: Administered at baseline
measure: Pain resilience at 8 weeks post baseline
timeFrame: Administered at 8 weeks post baseline
measure: Pain resilience at 12 weeks post baseline
timeFrame: Administered at 12 weeks post baseline
measure: Pain catastrophizing at baseline
timeFrame: Administered at baseline
measure: Pain catastrophizing at 8 weeks post baseline
timeFrame: Administered at 8 weeks post baseline
measure: Pain catastrophizing at 12 weeks post baseline
timeFrame: Administered at 12 weeks post baseline
measure: Patient adherence at baseline
timeFrame: Administered at baseline
measure: Patient adherence at 8 weeks post baseline
timeFrame: Administered at 8 weeks post baseline
measure: Patient adherence at 12 weeks post baseline
timeFrame: Administered at 12 weeks post baseline
measure: Sleep disturbance at baseline using the PROMIS measure
timeFrame: Administered at baseline
measure: Sleep disturbance at 8 weeks post baseline using the PROMIS measure
timeFrame: Administered at 8 weeks post baseline
measure: Sleep disturbance at 12 weeks post baseline using the PROMIS measure
timeFrame: Administered at 12 weeks post baseline
Other outcomes:
measure: Use of prescription medication in the patient's Electronic Health Record at 12 weeks post baseline
timeFrame: EHR data pull at 12 weeks post baseline
measure: Use of non-prescription medication in the patient's Electronic Health Record at 12 weeks post baseline
timeFrame: EHR data pull at 12 weeks post baseline
measure: Results of physical examinations in the patient's Electronic Health Record at 12 weeks post baseline
timeFrame: EHR data pull at 12 weeks post baseline
Locations:
city: Chicago
country: United States
facility: Osher Center for Integrative Medicine
state: Illinois
Study officials:
References: