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

NCT03699553 | Completed

• 1 other identifier: SP0042991
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Musculoskeletal Pain

Keywords

online intervention; chronic pain; positive emotion; affective science

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 weeks; from baseline to 12 weeks post baseline

Secondary Outcomes (45)

• Self-Reported Medication use at baseline

  Administered at baseline

• Self-Reported Medication use at 8 weeks post baseline

  Administered at 8 weeks post baseline

• Self-Reported Medication use at 12 weeks post baseline

  Administered at 12 weeks post baseline

• 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

Other Outcomes (3)

• Use of prescription medication in the patient's Electronic Health Record at 12 weeks post baseline

  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

  EHR data pull at 12 weeks post baseline

• Results of physical examinations in the patient's Electronic Health Record at 12 weeks post baseline

  EHR data pull at 12 weeks post baseline

Study Arms (2)

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).

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.

Behavioral: Emotion Reporting Control Group

Interventions

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

8 positive emotion skills taught over 5-6 weeks to help individuals cope with chronic pain and stress.

Intervention

Emotion Reporting Control Group BEHAVIORAL

Attention matched control condition, participants will report their daily emotions over 5-6 weeks online.

Emotion Reporting Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• BraveNet: collaborator

Study Sites (1)

Osher Center for Integrative Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: October 9, 2018
• Study Start: October 15, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

US (1)