None listed
Conditions
Brief summary
A recent trial with 89 participants (ACTRN12622000113752) demonstrated the efficacy and safety of an accessible online therapy for people with chronic pain (Pain and Emotion Therapy) which focused on improving emotion regulation through guided group sessions and home practice using an app and handbook. Results showed significant improvements in emotion dysregulation and provided preliminary evidence to improve the trials secondary outcomes of pain severity, depression, anxiety, sleep and quality of life. The primary aim of the current randomised controlled trial is to evaluate the efficacy of an individualised (one-on-one) version of Pain and Emotion Therapy to reduce pain severity. Secondary aims include evaluating the effects on depression, anxiety, sleep problems, pain disability, emotion dysregulation, and quality of life.
Interventions
This trial is a two-arm parallel randomised controlled trial with participants with chronic 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. TAU may include both pharmacological (e.g. analgesic medicatio
This trial is a two-arm parallel randomised controlled trial with participants with chronic 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. TAU may include both pharmacological (e.g. analgesic medication) and non-pharmacological treatment (e.g. physiotherapy). Pain and Emotion Therapy will be delivered online using three components: Zoom videoconferencing, a mobile app, and a printed handbook. Participants will receive eight one-on-one therapy sessions via Zoom with a therapist, each lasting 60 minutes approximately every 7 days over eight weeks. In addition to the sessions, participants will have access to the Pain and Emotion Therapy App where they will be encouraged to practice daily using their own smart device (e.g., smartphone or computer) with a secure, individual username and password. The app includes videos and interactive tasks to support skills practice between Zoom sessions. Participants will also receive a printed handbook by mail approximately one week prior to the intervention starting. The content of the handbook is based on the Dialectical Behavioural Skills Training Manual (Linehan, 2015), with additional content and psychoeducation about the association between chronic pain and emotions. The handbook will be referred to during the Zoom sessions and will facilitate homework and skills practice in app. Overall, the intervention is designed to teach psychological skills in mindfulness, emotion regulation, and distress tolerance, along with psychoeducation about chronic pain. Each weekly session builds on the previous one, providing a structured and sequential approach to skills development across the nine-week intervention period. This format replicates that used in a previous randomised controlled trial, in which no difficulties with participant adherence or safety issues were observed (Norman-Nott et al., 2025). The intervention will be delivered in accordance with the established study protocol developed and trialled by Norman-Nott et al. (2025). Participant adherence will be monitored by the therapists during the weekly sessions to ensure compliance with the treatment protocol (e.g. session attendance and app usage).
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 No maximum
Healthy volunteers
No
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 mobile app. c) Commits to fully participate in the eight sessions and train skills daily using the PaET App. d) Fluent in speaking and reading English. e) Persistent or reoccuring pain for at least 3 months ( IASP, 2020) f) Have an average pain rating equal to, or greater than 4 out of 10 for the past seven days (Langford et al., 2023)
Exclusion criteria
a) Diagnosed psychotic or personality disorder (e.g., schizophrenia, borderline personality disorder, bipolar disorder, etc.) b) Uncontrolled mental health disorder (e.g., persistent depressive disorder). c) Diagnosis for dementia or neurological condition substantially affecting cognition. d) At risk of suicide (e.g., recent suicidal ideation, suicide attempt, or current suicide plan). e) Familiar with dialectical behavioural therapy (e.g. received DBT as an intervention in the past either online or in-person) f) Planned surgery or substantial medication changes during the trial period. g) Located outside of Australia.
Outcome results
None listed