A randomised controlled trial of an internationally-available, self-guided, online pain management program for adults

• Register: ANZCTR
• Last refreshed on: 9 January 2023
• Main ID: ACTRN12617001133325
• Date of registration: 02/08/2017
• Prospective Registration: Yes
• Primary sponsor: Department of Psychology, Macquarie University
• Public title: A randomised controlled trial of an internationally-available, self-guided, online pain management program for adults
• Scientific title: The Pain Course: Exploring the efficacy of an international self-guided online pain management program for adults with chronic pain.
• Date of first enrolment: 17/06/2019
• Target sample size: 1000
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12617001133325.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Canada, Ireland, New Zealand, South Africa, United Kingdom, United States of America

Contacts

• Name: Dr Vincent Fogliati

• Name: Dr Vincent Fogliati

Key inclusion & exclusion criteria

Inclusion criteria: 1. Have experienced chronic pain for longer than 6 months
2. Have had their pain assessed and managed by a GP or specialist to rule out malignant or treatable causes
3. Are aged 18 or older
4. Are living outside of Australia
Exclusion criteria: 1. Significant suicidal ideation (indicated by a score >2 to Question 9 of the PHQ-9)
2. Self-reported risk of suicide
3. Unable to read and understand English

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Chronic pain;Depression;Anxiety;
Chronic pain
Depression
Anxiety

Mental Health - Anxiety

Anaesthesiology - Pain management

Mental Health - Depression

Intervention(s)

In this randomised controlled trial, all participants will receive access to an 8 week internet-delivered, self-guided education course, the Pain Course, which teaches participants how to manage chronic pain, anxiety, and low mood. All participants will have experienced chronic pain for longer than 6 months.
The Pain Course comprises 5 online lessons, which provide information about evidence-based, cognitive behavioural strategies for managing pain, anxiety and depression. One lesson will be completed every 7 to 10 days. Each lesson will take about 20 minutes to read. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with chronic pain, depression, and anxiety, taking a further 20 minutes per week.
All participants will receive automatic emails to promote adherence and engagement. Specifically, participants will receive an automatic email: a) from the Clinic Director in the first week of the course to thank them for their participation; b) each time a new lesson becomes available; c) when they complete a lesson; d) if they have not started a given lesson within 7 days (i.e. a reminder email); e) in Week 4, to inform them that slight increases in symptoms at that point are not uncommon; f) in week 7 to encourage them to complete any remaining lessons by the end of week 8; g) in week 8 to remind them it is the last week and of the post-treatment questionnaires. As the receipt of some of these emails is contingent upon a participant’s activity (e.g. not completing a course within 7 days), the exact number of emails received will vary between participant. However, each will receive between 10 and 20 automatic emails over the duration of the course.
Participants in this research trial will be randomly

Primary Outcome(s)

Symptoms and severity of general anxiety will be measured by the two-item Generalized Anxiety Disorder Scale-7 (GAD-7).[Administered at initial application, pre-treatment, mid-treatment and post-treatment.]

The interference of pain on participants' life will be measured by the Pain Interference Scale (PIQ), a 7-item measure.[Administered at initial application, pre-treatment, mid-treatment and post-treatment.]

Symptoms and severity of depression will be measured by the two-item Patient Health Questionnaire-9 (PHQ-9).[Administered at initial application, pre-treatment, mid-treatment and post-treatment.]

Secondary Outcome(s)

Brief Illness Perception Questionnaire (BIPQ).[Pre-treatment and post-treatment Importantly, these changes were made before any participants were enrolled in the research trial.]

The acceptability and participant satisfaction with the Pain Course will be measured at post-treatment by the Treatment Satisfaction Questionnaire (TSQ), a 10-item measure developed by the research team conducting the present research. [TSQ: Post-treatment]

PROMIS 10 will be used as a measure of overall health. [Administered at initial application, pre-treatment, mid-treatment and post-treatment.]

The nature of participants’ pain, including its location, its severity and responsiveness to pain medications, will be measured by the Wisconsin Brief Pain Questionnaire (WBPQ), a 4-item composite secondary outcome.[Administered at initial application, pre-treatment, mid-treatment and post-treatment. ]

Big Five Inventory 10-item. [Pre-treatment and post-treatment]

Short Flourishing Scale (SFS)[Pre-treatment and post-treatment]

De John Gierveld Loneliness Scale (DLS) 6-item[Pre-treatment and post-treatment]

Secondary ID(s)

None

Source(s) of Monetary Support

Macquarie University

Ethics review

Status: Approved
Approval date: 01/05/2019
Contact:

Macquarie University Human Research Ethics Committee