None listed
Conditions
Brief summary
In a recent pilot study (ACTRN: 12620000604909) evidence was promising for the feasibility, acceptability and efficacy of an online skills training for people in chronic pain (internet-delivered dialectical behavioural therapy skills training; iDBT-Pain). We now aim to further investigate the effectiveness of iDBT-Pain in a Randomised Control Trial (RCT). iDBT-Pain is an online training to teach skills for more effective emotion regulation. iDBT-Pain utilises evidence-based protocols for DBT skills training and will be administered according to the DBT Skills Training manual (Linehan, 2015). The intervention includes eight group-based sessions delivered to participants via Zoom, and access to a web app. It is hypothesised that the iDBT-Pain intervention will significantly reduce emotion dysregulation in people with chronic pain. It is further hypothesised that there may be changes in secondary outcomes related to chronic pain, including, pain intensity, pain interference, trauma, depression, anxiety, stress, sleep quality, harm avoidance, coping behaviours, and satisfaction with life.
Interventions
Description of intervention(s) / exposure: This study is a pilot randomised controlled trial (RCT) to investigate the efficacy of an internet-delivered skills training for people with chronic pain. There are two arms to this trial (1) Treatment, and (2) Treatment-as-usual (described under comparator/control). Arm 1 (Treatment group) Participants in the treatment arm will receive the iDBT-Pain intervention (internet-delivered dialectical behavioural therapy skills training). This intervention is designed to teach skills from dialectical behavioural therapy, in mindfulness, emotion regulation, and distress tolerance alongside psychoeducation about chronic pain. The iDBT-Pain intervention involves a total of eight 60-90-minute-long sessions (including an introductory and concluding session), delivered over the internet using Zoom. The content in the sessions will include presentations covering the theory behind the association between chronic pain and emotions, demonstrations on how to practice DBT skills such as mindfulness to be present without judgement and will facilitate group discussions around specific skills-based activities. The sessions will be delivered to participants as part of a group of around 8 to 12 participants every 7 days across eight weeks. For the duration of the eight weeks, and for one week after the concluding session, participants will have continued access to a web app (iDBT-Pain web app) which participants will access on their own smart device (e.g., iPhone or computer) with their own secure password and username. The iDBT-Pain app includes videos and tasks to encourage skills practice in mindfulness, emotion regulation and distress tolerance between the Zoom sessions. Participants will be asked to practice skills in the app daily but will not be given a specific duration of time they need to practice. This format for the skills training mirrors that used in our successful pilot study (ACTRN: 12620000604909) where no difficulties in adherence were observed. To ensure fidelity and consistency, the iDBT-Pain skills training will follow the study protocol developed and trialled by Norman-Nott et al (2021). The iDBT-Pain intervention will be administered by a certified DBT skills trainer. It is not anticipated that participants will experience substantial distress associated with this intervention because it is a skills training designed to teach new capabilities in pain and emotion management and is not a psychotherapy. Nevertheless, the principal investigator is an AHPRA registered psychologist and can be contacted if any unforeseen distress arises because of the skills training. If for any reason participants do experience increased distress, they will be able to discontinue the program, and be referred to alternative sources of support.
Sponsors
Study design
Eligibility
Inclusion criteria
a) Adults aged 18 years or over. b) Have access to the internet to participant in the Zoom sessions and have access to a smart phone/ tablet device capable of running the iDBT-Pain web app. c) Commits to fully participate in the skills training e.g., attend all the iDBT-Pain sessions held weekly on Friday lunchtimes (12pm to 3pm AEST) and train skills daily using the iDBT-Pain app. d) Fluent in speaking and reading English. e) Average pain rating equal to or more than 3 for the past seven days (Numeric Rating Scale; NRS).
Exclusion criteria
a) Diagnosed psychiatric conditions or mental health disorder (e.g., schizophrenia, bipolar disorder, major depression etc) b) Diagnosis for dementia or Alzheimer’s disease c) Located outside of Australia