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

Northwestern University1 site in 1 country80 target enrollmentOctober 15, 2018

ConditionsChronic Pain Musculoskeletal Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Pain
Sponsor: Northwestern University
Enrollment: 80
Locations: 1
Primary Endpoint: Retention to the LARKSPUR Study from baseline to 12 weeks post baseline
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 15, 2018

End Date

December 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Northwestern University

Responsible Party

Principal Investigator

Judith Moskowitz

Professor

Northwestern University

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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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