Positive Affect as a Source of Resilience for Adults in Chronic Pain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2022-06-09

Brief Summary

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Fibromyalgia syndrome (FMS) is a chronic musculoskeletal condition characterized by widespread pain and tenderness, and often accompanied by impaired physical functioning, depressed mood, as well as deficits in positive affect (PA).Standard behavioral therapies typically focus on minimizing negative thoughts and emotions associated with pain and yield only modest treatment effects. Efforts are therefore needed to develop more effective psychological treatments for chronic pain by identifying new targets for intervention.

The objectives of this Stage I randomized pilot trial are to evaluate the feasibility, acceptability, and the impact of a previously developed online positive affect (PA) skills intervention -LARKSPUR (Lessons in Affect Regulation to Keep Stress and Pain UndeR control)-in a sample of Hispanic, non-Hispanic other, and non-Hispanic African American patients with fibromyalgia syndrome (FMS).

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Detailed Description

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Specific Aims:

Aim 1: To maximize relevance and acceptability of content and delivery of LARKSPUR intervention among patients with FMS, a chronic pain population with known deficits in PA. This aim will establish the feasibility (recruitment and retention) and acceptability (helpfulness, satisfaction, and impact) of the multicomponent LARKSPUR intervention in Hispanic, non-Hispanic African American and non-Hispanic other patients with FMS.

Aim 2: To conduct a randomized pilot trial to evaluate the impact of the LARKSPUR intervention in FMS pain (primary outcome), as well PA, depressive symptoms, physical functioning, and stress appraisals (secondary outcomes) and Aim 2a: explore racial/ethnic disparities.

For Aim 1, the study team will pilot LARKSPUR to examine feasibility and acceptability of the intervention framework by conducting frequency and descriptive statistics for enrollment rates, number of sessions completed, number of weeks required to complete the intervention, and Likert-scale items assessing satisfaction with the intervention and perceived helpfulness. For Aims 2, FMS patients (target N=90) will be randomized to receive the LARKSPUR content online or to complete daily emotion reports online (control). The researchers hypothesize that intervention participants will report more frequent PA, decreased depressive symptoms, enhanced physical functioning, improved stress appraisals, and reduced FMS pain (intensity and interference) immediately following the intervention (approximately 6-8 wks) and at 1-month post-intervention.

Conditions

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Geriatric Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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LARKSPUR intervention

Lessons in Affect Regulation to Keep Stress and Pain UndeR control

Group Type EXPERIMENTAL

LARKSPUR

Intervention Type BEHAVIORAL

This intervention used in our prior research consists of skills training exercises designed to increase the frequency of positive affect. The 6 week intervention (5 weeks of content plus one week of home practice) consists of 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.

Attention Control Condition

Daily emotion reporting/no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LARKSPUR

This intervention used in our prior research consists of skills training exercises designed to increase the frequency of positive affect. The 6 week intervention (5 weeks of content plus one week of home practice) consists of 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Access to daily internet
* ≥ 50 years of age
* Able to read and understand English
* Physician diagnosis confirmation of FMS AND/OR Score ≥ 13 on the 6-item, self-report fibromyalgia screening tool
* Report having pain for at least the last three months