None listed
Conditions
Brief summary
Difficulties in emotional regulation is one important factor in the development and maintenance of chronic pain. Some evidence already supports the potential for internet-delivered Dialectic Behaviour Therapy (iDBT) to reduce difficulties in emotional regulation and pain intensity. However, further studies are needed to provide bolster evidence regarding the effectiveness of iDBT in the chronic pain context. A single-case experimental design (SCED) with multiple baselines will be used to examine the effectiveness of iDBT-Pain skills training intervention to reduce difficulties in emotional regulation and pain intensity in people with chronic pain. Three participants with chronic pain will be recruited. Each participant will be randomised to a different baseline phase (i.e., 5, 9 or 12 days), which will then be followed by 6 sessions of 60-90min iDBT skills training intervention over a 4-week period including unlimited usage of the iDBT-Pain skills training web application. The Difficulties in Emotional Regulation Scale (DERS) will serve as the primary outcome measure. The visual analogue scale assessing average pain intensity will serve as the secondary outcome measure. Generalisation measures will assess sleep quality, coping, temperament and anxiety and depressive symptoms as well as medial prefrontal cortex glutamate concentration. SCEDs are considered a viable alternative approach to randomised clinical trials to identify evidence-based practices when recruitment of large samples is not feasible.
Interventions
This study will use a single-case experimental design (SCED) with multiple baselines across participants. The SCED method is based on assessing the dependent variables (emotional regulation and pain intensity) repeatedly for each of the participants across several phases. The design of this study will be AB + follow-up, where A refers to the baseline phase and B is the intervention phase. Three participants will be randomly assigned to different baseline durations. The baseline for the first participant will be 5 days, the second participant will have a 9-day baseline, and the third participant will have a 12-day baseline. All participants will start the baseline phase on the same day. During the baseline phase, participants will complete the self-report questionnaires (i.e., Visual Analogue Scale (VAS) and Difficulties in Emotion Regulation Scale (DERS)) on every day of the baseline phase. Each baseline phase will be followed by 6 sessions of internet delivered Dialectic Behaviour Therapy (iDBT) skills training intervention plus unlimited use of an iDBT skills training web application over a 4-week period. The follow up phase will begin the day after the intervention and will last for one week, whereby each participant will report on the primary and secondary dependent variables (emotional regulation and pain intensity respectively) in order to monitor possible changes in pain intensity and pain interference after completion of the intervention. Intervention: Six iDBT skills training intervention sessions will be delivered individually to each participant over the video conferencing platform Zoom at agreed times during the 4-week period. The iDBT skills training intervention is based on the iDBT protocol developed by Wilks et al. (2017) and has been modified for the chronic pain population (iDBT-Pain skills training intervention including two “Mindfulness” skill training intervention sessions, three “Emotional Regulation” skill training intervention sessions and one “Distress Tolerance” skill training intervention session). Each session will be administered by a researcher (in this trial an AHPRA registered psychologist) and is 60-90 minutes in duration. In-between the iDBT-Pain skills training intervention sessions the participants will be asked to train their newly learned DBT skills using the iDBT skills training web application developed by Wilks and colleagues (2018), which has been modified for the chronic pain population (iDBT-Pain skills training web application). No instruction will be given about the duration of usage of the iDBT-Pain skills training web application. The participants will be contacted everyday to ensure they are using the iDBT-Pain skills training we application.
Sponsors
Study design
Eligibility
Inclusion criteria
Three individuals with chronic pain will be recruited for this study. Participants need to meet the following inclusion criteria: (1) aged 18-80 years, (2) chronic pain for more than 6 months, and (3) demonstrating an ability to use the Visual Analogue Scale (VAS).
Exclusion criteria
Regarding the neuroimaging component of the study, individuals who have metal objects inside their body (e.g., stents, metal clips, implants and shrapnel) may be excluded.