Internet-Based Osteoarthritis Pain Coping Skills Intervention (PainCOACH)

The purpose of this study is to translate a proven pain coping skills intervention for osteoarthritis (OA) patients into an engaging and easy-to-use Internet-based intervention that uses innovative technologies to mimic traditional, in-person training sessions.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Behavioral: PainCOACH

Detailed Description

Twenty-one million Americans live with osteoarthritis (OA), a progressive joint disease that causes stiffness, pain, reduced range of motion, distress, and decrements in physical, social, and role functioning. Medical treatments for OA pain are limited and present risks, especially for older populations. However, cognitive behavioral pain coping skills interventions have proven effective for decreasing OA pain, disability, and distress. Unfortunately, existing programs reach a limited number of patients because they require patients to travel to receive in-person training. There is a need for interventions that address the needs of a larger proportion of the rapidly growing population of people whose functioning and quality of life are severely diminished by OA. Delivering proven pain management interventions via the Internet is a promising way to address this need, especially in light of increasing use of the Internet by older Americans. To be most effective, an Internet-based intervention would need to mimic key features of in-person interventions. The proposed intervention will do that by translating a proven in-person pain coping skills protocol into an interactive Internet-based application that uses multimedia and expert systems technology to mimic in-person interventions. It will provide individualized feedback, interactive problem solving, and animated demonstrations, and it will incorporate learning techniques from Bandura's Social Cognitive Theory, including modeling, mastery experiences, and social reinforcement. The project includes two phases, corresponding to two specific aims. In Phase I the investigators will translate the in-person intervention for delivery on the Internet. This phase will including gathering feedback from patient and expert therapist focus groups, which will help refine the program. In Phase II the investigators will conduct a small-scale randomized controlled trial that will enable us to examine and refine features designed to increase motivation and adherence over the course of the 8-week Internet-based intervention. The trial will also enable the investigators to demonstrate its feasibility, tolerability, safety, and promise. The investigators hypothesize that the trial will demonstrate the effectiveness of the Internet for delivery of this OA pain coping skills intervention. Taken together, these activities will prepare the program for testing in a full-scale randomized controlled trial in the next stage of this research. The promise of this project is enhanced by the multi-disciplinary research team, which has expertise in the conduct of cognitive behavioral interventions that teach OA patients to use coping skills to manage their pain, developing and implementing individualized computerized feedback reports using expert systems technology, and development of engaging, user-friendly, interactive computer-based programs for learning and assessment. Relevance: This Internet-based OA pain coping skills intervention targets a significant individual and public health problem and expands access to an empirically-supported pain self-management program so that it can reach a greater proportion of the large and growing population of people suffering from OA pain and related disability.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University
    • Smithfield, North Carolina, United States, 27577
      • UNC-CH Thurston Arthritis Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A formal clinical diagnosis of OA affecting one or both knees or hips
• Significant OA pain
• Must be aged 18 or older
• Must be English speaking

Exclusion Criteria:

• Not fluent in English
• Have less than 7th grade English reading proficiency
• Show signs of cognitive impairment that would prevent comprehension of consent procedures or study measures and procedures
• Have a medical condition that would contraindicate safe participation in the study (as determined by study physician)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Study arm will complete the 8-week Internet-based pain coping skills program.	Behavioral: PainCOACH; The 8-week Internet-based pain coping skills intervention program includes 8 sessions. Each session takes 30-45 minutes to complete and includes text, illustrations, photos, animations, audio narration, interactivity, and delivery of personalized feedback. Users will be expected to complete 1 session per week.
No Intervention: Control Group; This study arm will only provide demographic and pain-related information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity	The Arthritis Impact Measurement Scale-2 (AIMS-2) pain subscale that measures severity of arthritis pain, frequency of severe pain, duration of morning stiffness, frequency of joint pain, and difficulty sleeping due to pain	Baseline to post-intervention (at approximately 10 weeks and at 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain-related anxiety	Pain Anxiety Symptoms Scale, 20 item version (PASS-20), which assesses fear of pain, cognitive anxiety, escape-avoidance behaviors, and physiological symptoms of anxiety	Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Change in pain-related interference with functioning	Arthritis Impact Measurement Scale-2 (AIMS-2) functioning subscales, summed across mobility, walking/bending, self- care, household tasks, social activities, work activities	Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Change in bodily relaxation	From a behavioral observation task; assessed with brief self-report measure of perceived relaxation and electromyograph (EMG) monitor using external electrodes measuring frontalis muscle tension and indicated by change in frontalis muscle tension during the relaxation task and muscle tension achieved at end of task	Baseline to post-intervention (at approximately 10 weeks)
Change in problem solving skills	From a behavioral observation task; quality and quantity of responses to hypothetical situation describing a pain flare and asking participants how they would manage it, along with subjective success assessed with an adapted version of the Arthritis Self-Efficacy scale (ASE)	Baseline to post-intervention (at approximately 10 weeks)
Change in emotional adjustment	Positive and Negative Affect Schedule-20 item version (PANAS)	Baseline to post-intervention (at approximately 10 weeks)
Program Usability	To help assess tolerability of the intervention site; for intervention arm participants only; qualitative (open-ended) questions to gather feedback on PainCOACH program (usability, usefulness, influence on attitudes/motivation, likes/dislikes)	Post-intervention (at approximately 10 weeks)
Number of participants recruited	To assess feasibility	up to 10 weeks
Number of participants who complete the study	To assess tolerability	through 10 weeks and/or 6 months
Number of participants who adhere to study protocol	To assess tolerability	through 10 weeks and/or 6 months
Medication type and frequency of use during the past week	To help assess types of medication used for arthritis pain	Baseline, mid-point, and post-intervention
Change in and use of pain coping strategies	Adapted Coping Strategies Questionnaire (CSQ), Chronic Pain Coping Inventory (CPCI) subscales, West Haven-Yale Multidimensional Pain Inventory (WHYMPI) subscales, and additional items that measure use of strategies taught	Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Personality	Ten-Item Personality Inventory (TIPI)	Baseline
Change in self-efficacy for pain management	Arthritis Self-Efficacy scale (ASE)	Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Change in social support	Adapted West Haven-Yale Multidimensional Pain Inventory (WHYMPI) subscale	Baseline to post-intervention (at approximately 10 weeks)

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Christine Rini, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: June 21, 2012
• First Submitted That Met QC Criteria: July 9, 2012
• First Posted (Estimate): July 12, 2012

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 10-1384; 5R01AR057346-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No