None listed
Conditions
Brief summary
A recent trial (ACTRN12622000113752) with 89 participants demonstrated the efficacy and safety of an online group-based therapy for people with chronic pain, Pain and Emotion Therapy plus TAU (PaET plus TAU). Results showed significant improvements in emotion dysregulation and provided preliminary evidence for a significant reduction in pain severity, depression, anxiety, stress, sleep problems and improved wellbeing (Norman-Nott et al., 2025). The aim of the current randomised controlled trial is to evaluate the efficacy of Pain and Emotion Therapy+ plus TAU, with an additional module on pain and movement education added to the program to reduce pain severity. Secondary aims include evaluating the effects on pain disability, emotion dysregulation, depressive symptoms, anxiety symptoms, sleep quality, level of physical activity, resilience, post-traumatic stress disorder symptoms, suicide cognitions and quality of life.
Interventions
This is a two-arm parallel randomised controlled trial involving participants with chronic low back pain randomised to either: "Pain and Emotion Therapy+ plus treatment-as-usual" or "treatment-as-usual" only.
Arm 1 (treatment), "Pain and Emotion Therapy+ plus treatment-as-usual": Participants in the treatment condition will receive Pain and Emotion Therapy+ over nine weeks, in addition to their usual treatments and care as clinically indicated. Pain and Emotion Therapy+ includes nine Zoom sessi
This is a two-arm parallel randomised controlled trial involving participants with chronic low back pain randomised to either: "Pain and Emotion Therapy+ plus treatment-as-usual" or "treatment-as-usual" only. Arm 1 (treatment), "Pain and Emotion Therapy+ plus treatment-as-usual": Participants in the treatment condition will receive Pain and Emotion Therapy+ over nine weeks, in addition to their usual treatments and care as clinically indicated. Pain and Emotion Therapy+ includes nine Zoom sessions with a therapist approximately every 7 days delivered over nine weeks, continued access to a mobile app and a printed handbook with exercises for home practice. During the nine Zoom sessions, participants will receive skills training in emotion regulation, pain and movement-based education. These sessions are 60-75 minutes in duration, and are group-based, involving 19-20 participants in each session. The printed handbook has been developed specifically for this trial, and summarises the content delivered in the Zoom sessions, containing additional sections for note-taking, as well as worksheets to support home-based practice of the skills learned (i.e., emotion regulation skills, movement-based pain-management strategies). The mobile app includes videos and interactive tasks to support skill practice between sessions, and participants will be provided with a set of clear instructions to set up the app. Session attendance will be monitored, as will participants' app usage (i.e., frequency, time spent inside the app). No personal data will be stored on the mobile app.
Sponsors
UNSW Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
a) Adults 18-80 years of age inclusive. b) Primary complaint of pain in the area between the 12th rib and buttock crease with or without accompanying leg pain. c) Low back pain of at least 12 weeks in duration. d) Mean pain intensity rating greater than or equal to a 4 out of 10 for the past seven days on the Numerical Rating Scale (NRS). e) Sufficient fluency in the English language to understand and respond to English language questionnaires and to engage with the intervention. f) Have access to the internet to participant in the Zoom sessions and have access to a smart phone/ tablet device capable of running the mobile app and supplementary video content. g) Commits to fully participate in the nine online sessions held weekly on Friday lunchtimes (12pm to 3pm; AEST) and train skills daily using the mobile app. h) Residing in Australia.
Exclusion criteria
a) Do not have access to the internet or have no access to a smart device (e.g. phone or tablet) to complete the weekly Zoom sessions and train the skills using the app. b) Diagnosed psychotic and personality disorders (e.g., schizophrenia, borderline personality disorder, bipolar disorder, etc.). c) Uncontrolled mental health disorder (e.g., persistent depressive disorder). d) Diagnosis for dementia or neurological condition substantially affecting cognition. e) At risk of suicide (e.g., recent suicidal ideation, suicide attempt, or current suicide plan). f) Familiar with dialectical behavioural therapy (e.g. received DBT as an intervention in the past either online or in-person). g) Has previously participated in, or is currently participating in a prior trial of the same intervention. h) Planned surgery or substantial medication changes during the trial period. i) Located outside of Australia.
Outcome results
None listed