Living Well with Chronic Pain (EPIO)

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Chronic Pain, Widespread

Treatments: Behavioral: EPIO

Study type: Interventional

Funder types: Other

Identifiers

NCT03705104

2018/799

Details and patient eligibility

About

The goal of this project is to test the effect of an interactive e-health intervention for people with chronic pain.

Full description

Chronic pain conditions are common and difficult to cure. As much as 30% of adults in Norway experience moderate-to-severe chronic pain, i.e., pain having lasted more than 3 months. Chronic pain is also the most common cause of sick leave and disability pension in Norway. Despite a clear request from the authorities, e-health interventions for chronic pain has not yet been tested and implemented.

The aim of this study is to investigate the effect of an interactive e-health intervention for people living with chronic pain, using outcome measures such as pain intensity, pain acceptance, anxiety/depression and quality of life.

The e-health intervention will first be tested in a pilot study with 50 patients with different pain diagnoses and eventually in a randomized controlled trial with a sample of 240 patients with different pain diagnoses. The intervention will consist of one face-to-face introductory group followed by 9 app-based modules containing cognitive behavioral pain self-management material. The 9 modules will be distributed over minimum 27 days (minimum 3 days per module). The participants in the randomized controlled trial will be randomly assigned to use the e-health intervention or to a treatment as usual control group. Both groups will receive outcome measures to complete at baseline and at 3, 6 and 12 months.

Post-RCT, the EPIO study will also include a non-randomized group receiving the app-based EPIO program but without receiving an introduction session and follow up phone calls to examine potential benefits from receiving the app-based program only.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic pain (pain > 3 months)
• > 18 years of age
• Able to write/read/speak Norwegian
• Have their own smart phone, PC or tablet

Exclusion criteria

• Cancer related pain
• Migraine

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 3 patient groups

EPIO (e-health intervention)

Experimental group

Description:

Participants will get access to one module every third day (total 9 modules). The app consists of cognitive behavioral pain self-management material, including educational material and relaxation training exercises.

Treatment:

Behavioral: EPIO

treatment as usual

No Intervention group

Description:

Participants will get treatment as usual during the study. All participants will get access to the app after ended study if interested.

Experimental without introduction group and follow up phone calls

Active Comparator group

Description:

One extra arm (non randomized) has been included to examine whether participants who receive the EPIO intervention without receiving an introduction session and follow up phone calls will still describe benefiting from the receiving the intervention

Treatment:

Behavioral: EPIO