Efficacy of the iDBT-Pain skills training intervention to reduce emotional dysregulation and pain intensity in people with chronic pain: protocol for a single-case experimental design with multiple baselines

Abstract

IntroductionDifficulties in emotional regulation are key to the development and maintenance of chronic pain. Recent evidence shows internet-delivered dialectic behaviour therapy (iDBT) skills training can reduce emotional dysregulation and pain intensity. However, further studies are needed to provide more definitive evidence regarding the efficacy of iDBT skills training in the chronic pain population.Methods and analysisA single-case experimental design (SCED) with multiple baselines will be used to examine the efficacy of a 4-week iDBT-Pain skills training intervention (iDBT-Pain intervention) to reduce emotional dysregulation and pain intensity in individuals with chronic pain. The iDBT-Pain intervention encompasses two components: (1) iDBT-Pain skills training sessions (iDBT-Pain sessions) and (2) the iDBT-Pain skills training web application (iDBT-Pain app). Three individuals with chronic pain will be recruited and randomly allocated to different baseline phases (5, 9 or 12 days). Following the baseline phase, participants will receive six 60–90 min iDBT-Pain sessions approximately 4 or 5 days apart, delivered by a psychologist via Zoom. To reinforce learnings from the iDBT-Pain sessions, participants will have unlimited use of the iDBT-Pain app. A 7-day follow-up phase (maintenance) will follow the intervention, whereby the iDBT-Pain sessions cease but the iDBT-Pain app is accessible. Emotional regulation, as the primary outcome measure, will be assessed using the Difficulties in Emotion Regulation Scale. Pain intensity, as the secondary outcome measure, will be assessed using a visual analogue scale. Generalisation measures will assess psychological state factors (depression, anxiety and coping behaviour), alongside sleep quality, well-being and harm avoidance. SCEDs are increasingly considered effective designs for internet-delivered psychological interventions because SCED enables the investigation of interindividual variability in a heterogeneous population such as chronic pain.Ethics and disseminationThis trial was approved by the University of New South Wales (HC200199). Results will be published in peer-reviewed journals.Trial registration numberACTRN12620000604909.

Internet-Delivered Dialectical Behavioral Therapy Skills Training for Chronic Pain: Protocol for a Randomized Controlled Trial

“…Evidence is arising that DBT may be a viable intervention to target emotion dysregulation in people with chronic pain, helping reverse this cycle of pain and emotional distress and leading to improved physical and psychological function [ 35 - 37 ]. Specifically, iDBT-Pain, a guided internet-delivered approach encompassing live web-based sessions and access to an app, has been found in a previous SCED trial to reduce symptoms of emotion dysregulation and pain intensity [ 46 ].…”

“…In addition to the iDBT-Pain sessions and app, there will be an introductory session to explain the trial and a concluding session. To develop iDBT-Pain [ 46 ], evidence-based protocols for DBT skills training according to the DBT Skills Training Manual [ 39 ] were used. Participants in the treatment group may continue to receive their usual care (eg, medication and physiotherapy) while in the trial; any such treatment will be monitored (see the Medication and Health Intervention Measures section).…”

“…The sample size for this trial was calculated using the SAS software (version 9.4; SAS Institute) of the SAS system (SAS and all other SAS Institute Inc product or service names are registered trademarks or trademarks of SAS Institute Inc in the United States and other countries) and is based on the large effect size (pain intensity; effect size=0.81) obtained from our previous trial [ 46 ]. The power analysis is based on the effect size of the secondary outcome from the previous trial rather than the primary outcome effect size of 0.88 for emotion dysregulation to obtain a more cautious sample size estimate given that the previous trial was conducted with a small population using a single-case design.…”