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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention

NCT06483568

Well-Being, Psychological

NOT_YET_RECRUITING NA

Researching Emotions And Cardiac Health: Phase III

NCT03220204

Congestive Heart Failure Emotions Patient Compliance

COMPLETED NA

Positive Psychology for ACS Patients: a Factorial Design Study

NCT02754895

Acute Coronary Syndrome

COMPLETED NA

Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving.

NCT05847881

Chronic Pain

COMPLETED NA

Motivation-Audit-Positive Psychology Intervention Study

NCT03160755

Metabolic Syndrome

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain Musculoskeletal Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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).

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Emotion Reporting Control

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.

Group Type ACTIVE_COMPARATOR

Emotion Reporting Control Group

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type BEHAVIORAL

Emotion Reporting Control Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No