None listed
Conditions
Brief summary
The primary objective is to evaluate, through a randomised controlled trial, the clinical efficacy of an Internet-delivered pain self-management program, the Youth Pain Course, for adolescents with chronic pain. Clinical efficacy will be assessed through clinically meaningful (>30%) improvements in primary (physical functioning) and secondary (pain effects, emotional functioning, role functioning) outcomes at post-treatment. We hypothesise that: (a) The Youth Pain Course will result in improvements in physical functioning at the completion of treatment; (b) The Youth Pain Course will result in improvements in pain effects (intensity, frequency, affect and cognitions), emotional functioning (anxiety and depressions symptoms), and role functioning (quality of life, school presenteeism and absenteeism) at the completion of treatment; and (c) Improvements on primary and secondary outcomes will be maintained at 3- and 12-months post-treatment. The secondary objectives of this project are to explore predictors and moderators of treatment response to guide program improvements and research directions. These objectives are exploratory, and no specific hypotheses can be made; however, the results of these analyses will guide the further development, evaluation and eventual deployment of the treatment.
Interventions
The Youth Pain Course comprises 6 modules, delivered via the Internet over 8 weeks.
The modules provide adolescents with information and skills for the management of chronic pain generally as well as the comorbid pain-related disability, anxiety and depression that often result. Module content is structured around four themes, common in CBT-based psychological pain management interventions: (1) Education, (2) Behavioural skills, (3) Cognitive strategies, and (4) Relapse prevention.
Each m
The Youth Pain Course comprises 6 modules, delivered via the Internet over 8 weeks. The modules provide adolescents with information and skills for the management of chronic pain generally as well as the comorbid pain-related disability, anxiety and depression that often result. Module content is structured around four themes, common in CBT-based psychological pain management interventions: (1) Education, (2) Behavioural skills, (3) Cognitive strategies, and (4) Relapse prevention. Each module will take approximately 20 minutes to complete. Content will be delivered onscreen via text, illustrations, video and audio and will involve a variety of examples. Modules will be accompanied by an activity (e.g., goal setting, activity pacing, thought challenging) participants will work through during the week, and detailed case examples of other adolescents with different chronic pain conditions. Participants will be asked to practice the activities at least three times a week, for around 30 minutes each time. Caregivers will also be provided with online materials to support their child. Each week participants will have brief contact lasting around 10-15 minutes with a nationally registered psychologist, who will support the family’s progress through the course via phone calls or through a private messaging system. Psychologists supporting families through the course will receive training and supervision from senior clinical psychologists in the team to ensure competence and safety in their practice. Participants will also receive automated email and/or text message reminders prompting and reminding the practice of skills and progression through the course. Study questionnaires will be administered to adolescents and caregivers at application, pre-treatment, mid-treatment, post-treatment, and at 3- and 12-month follow-up. The major sets of questionnaires will take about 20-minutes to complete.
Sponsors
Macquarie University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1) Aged between 12-17 2) Presence of persistent or recurrent pain for three months or more 3) Experiencing the impact of pain on at least one area of daily functioning 4) Lives with a parent (or primary caregiver), who is willing to take part in the trial 5) Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Exclusion criteria
Adolescent exclusion criteria are: 1) Imminently suicidal or unable to keep themselves safe 2) Parent-reported child developmental disability which would impede participation 3) Currently receiving treatment for a serious medical condition (e.g., cancer, transplant) 4) Does not have access to a computer or the internet 5) Unable to read and understand English. Caregiver exclusion criteria are: 1) Imminently suicidal or unable to keep themselves safe 2) Does not have access to a computer or the internet 3) Unable to read and understand English.
Outcome results
None listed