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Positive Affect as a Source of Resilience for Adults in Chronic Pain (LARKSPUR Study)

Clinical Trial Details

This research study —LARKSPUR (Lessons in Affect Regulation to Keep Stress and Pain UndeR control)—aims to evaluate the feasibility and acceptability of an intervention focused on improving pain-related outcomes and increase psychological resources to cope with stress. 

This intervention consists of skills training exercises designed to increase the frequency of positive affect. The intervention consists of 5 weeks of content plus one week of home practice with five components: (1) Positive events and gratitude; (2) mindfulness; (3) reappraisal; (4) strength and goals; and (5) acts of kindness. Participants will have up to 8 weeks to complete this intervention.

You will be “randomized” into one of two study groups: an intervention or an attentional control group. Randomization means that you are put into a group by chance. It is like flipping a coin. Neither you nor the researchers will choose what group you will be in. You will have an equal chance of being placed in any group. You will be assigned to one of two groups; the study plan for each group is described below:

Group 1 – Intervention: Active intervention participants participate in a 6 to 8 week online course focused on improving pain-related outcomes and increase psychological resources to cope with stress . As part of the intervention, participants will learn and practice skills, including gratitude, savoring, and mindfulness. You will be asked to login to the website daily for 6 to 8 weeks to report your emotions and also receive some basic instruction, and these will not take longer than 90 minutes per week.

Group 2 – Attention Control: Participants in the attention control group will login to the website to complete daily emotion check-ins for 6 to 8 weeks. We predict that these daily check-ins will take about 5 minutes to complete each day.

Both Groups: All participants will complete online questionnaires at three time points; at the start of the study, immediately following the 6 to 8 weeks of intervention or attention control, and 1-month after your last daily survey on the website. These questionnaires take about 60-75 minutes to complete and may be done by phone/videoconference.

Eligible participants will be compensated up to $142 for completing the study over 4 months. Details will be discussed with the study team.

Key Eligibility: 

Inclusion criteria are:
1) Access to daily internet
2) Greater than or equal to 50 years of age
3) Be fluent in and able to read and write in English
4) Physician diagnosis of Fibromyalgia.

Exclusion criteria are:
1) Severe cognitive impairment
2) Current behavioral treatment for pain
3) Enrollment in another pain study.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Mubarak Sanni
212-746-1758
larkspur@med.cornell.edu

Lower Manhattan

Contact(s)

Mubarak Sanni
212-746-1758
larkspur@med.cornell.edu

Westchester

Contact(s)

Mubarak Sanni
212-746-1758
larkspur@med.cornell.edu

Brooklyn

Contact(s)

Mubarak Sanni
212-746-1758
larkspur@med.cornell.edu

Queens

Contact(s)

Mubarak Sanni
212-746-1758
larkspur@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2006022291

ClinicalTrials.gov:

NCT04869345

Status

Open to Enrollment

Age Group

Adult

Sponsor