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

Northwestern University

Status: Completed

Conditions: Musculoskeletal Pain; Chronic Pain

Treatments: Behavioral: Emotion Reporting Control Group; Behavioral: LARKSPUR; Online Positive Emotions Skills for Individuals with Chronic Musculoskeletal Pain

Study type: Interventional

Funder types: Other

Identifiers

NCT03699553

SP0042991

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intervention

Experimental group

Description:

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).

Treatment:

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

Emotion Reporting Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Emotion Reporting Control Group