Internet-based Behavioral Pain Management

NCT ID: NCT01918189

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-01
• Study Completion Date: 2018-12-31

Brief Summary

The purpose of the proposed project is to develop and test how well an internet-based behavioral pain self-management program, the Pain EASE program, can be used for treating low back pain in Veterans. Veterans' experiences with usability and satisfaction with the Pain EASE program will also be examined. Behavioral interventions such as exercise and cognitive behavior therapy are known to be effective for low back pain but are often not readily available or easily accessed. Veterans will be able to access the Pain EASE program via their computer with an internet connection, which will increase access to this type of treatment. Study participants will receive 10 weeks of access to the Pain EASE program, which will teach them pain coping skills to manage their low back pain. The primary outcome is pain-related functional interference.

Detailed Description

OBJECTIVES: The primary objectives of the proposed study are to: (1) develop an integrative, Internet-based, Veteran-centered behavioral intervention, the Pain EASE program for chronic low back pain (CLBP), and (2) examine preliminary efficacy, usability, and satisfaction of this intervention in a representative sample of Veterans with CLBP. The primary hypothesis states that a clinically meaningful reduction in pain-related functional interference will be observed following ten weeks of exposure to the Pain EASE program relative to baseline. The secondary hypotheses state that clinically meaningful reductions in ratings of average pain intensity on a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale at the ten week post-baseline follow-up assessment interval will be observed, in addition to statistically significant reductions in fatigue, sleep problems, depressive symptoms, and negative mood at the ten week post-baseline assessment. The tertiary hypotheses state that participants will report high levels of interest, site usage, and satisfaction.

RESEARCH DESIGN: A non-randomized pilot study with two phases is proposed to develop and evaluate an internet-based behavioral pain self-management program. Phase I will solely involve qualitative data collection. Repeated quantitative assessments during Phase II will be conducted at baseline and 10-weeks post-baseline.

METHODOLOGY: A 24-month pilot study with two phases is proposed. During Phase I, the Pain EASE program will be developed and feedback from 15 Veterans with CLBP and an Expert Panel of pain management clinicians will be used to modify the program. During Phase II, a pilot feasibility trial of the Pain EASE program with 55 Veterans with CLBP will be conducted. Subjects will be a total of 70 patients receiving care at the VA Connecticut Healthcare System (VACHS) who report chronic low back pain. The primary criteria for inclusion are constant pain of at least three months duration with at least a moderate level of average pain (i.e., scores of 4 or greater on a 0 [no pain] to 10 [worst pain imaginable]) on a numerical rating scale of pain and indication of the "preparation", "action", or "maintenance" stage of readiness to change on a brief five item staging checklist. All patients must have access to a computer with an internet connection. Excluded will be patients with life threatening or acute physical illness, current alcohol or substance abuse or dependence, current psychosis, suicidal ideation, dementia, and individuals seeking surgical pain treatment. All participants will continue to receive their usual care from Veterans Health Administration (VHA) providers. During the 10-week therapeutic window, weekly telephone calls from research staff will serve to cue and monitor participants' use of the Internet program. At ten weeks post-baseline, participants will be formally reassessed. Primary and secondary hypotheses involving quantitative data will be analyzed using an intent-to-treat principle and will employ t-tests and non-parametric analogs and regression analyses.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

10 week Pain EASE access

behavioral pain self-management intervention (Pain EASE) delivered via the Internet

Group Type: EXPERIMENTAL

behavioral pain self-management intervention Pain EASE

Intervention Type: BEHAVIORAL

10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing

Interventions

behavioral pain self-management intervention Pain EASE

10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Presence of at least a moderate level of chronic low back pain (i.e., numeric rating scale pain scores of 4) and presence of low back pain for a period of 3 months;
• Availability of a computer with Internet access;
• Indication of the "preparation", "action", or "maintenance" stage of readiness to change on a brief five item staging checklist and a rating of at least 4 or greater on a 0 (not at all interested) to 10 (extremely interested) rating scale designed to ensure participants' interest in receiving pain self-management via the Internet;
• Veteran receiving care at VA Connecticut Healthcare System

Exclusion Criteria

• life threatening or acute medical condition that could impair participation (e.g., severe COPD, lower limb amputation, terminal cancer);
• psychiatric condition (e.g., active substance abuse, psychosis or suicidality) that could impair participation
• surgical interventions for pain during their participation in this study
• sensory deficits that would impair participation (e.g., visual impairment affecting ability to navigate Internet-based intervention).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana M. Higgins, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Locations

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

Countries

United States

References

Reuman L, Solar C, MacLean RR, Halat AM, Rajeevan H, Williams DA, Heapy AA, Bair MJ, Krein SL, Kerns RD, Higgins DM. If you personalize it, will they use it?: Self-reported and observed use of a tailored, internet-based pain self-management program. Transl Behav Med. 2022 May 26;12(5):693-701. doi: 10.1093/tbm/ibab165.

Reference Type: DERIVED

PMID: 35192703 (View on PubMed)

Higgins DM, Buta E, Williams DA, Halat A, Bair MJ, Heapy AA, Krein SL, Rajeevan H, Rosen MI, Kerns RD. Internet-Based Pain Self-Management for Veterans: Feasibility and Preliminary Efficacy of the Pain EASE Program. Pain Pract. 2020 Apr;20(4):357-370. doi: 10.1111/papr.12861. Epub 2020 Jan 28.

Reference Type: DERIVED

PMID: 31778281 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

D0998-R

Identifier Type: -

Identifier Source: org_study_id