Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000870459p
Ethics application status
Submitted, not yet approved
Date submitted
28/07/2025
Date registered
12/08/2025
Date last updated
12/08/2025
Date data sharing statement initially provided
12/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain and Emotion Therapy (PaET) for People with Chronic Pain
Scientific title
Efficacy of Pain and Emotion Therapy (PaET) to reduce Pain Severity in People with Chronic Pain: A Randomised Controlled Trial
Secondary ID [1] 314747 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12622000113752 is the clinical trial registration for a prior trial which investigated an early version of Pain and Emotion Therapy for groups, named iDBT-Pain. This trial demonstrated intervention safety and efficacy to reduce emotion dysregulation, and potential improvements in pain severity (secondary outcome). The current study is a RCT which seeks to further investigate effects to reduce pain severity.

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 337961 0
Condition category
Condition code
Anaesthesiology 334279 334279 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 331351 0
Treatment: Other
Comparator / control treatment
Arm 2 (control), "Treatment-as-usual": Participants in the control group will receive treatment-as-usual (TAU) only, meaning they will continue to receive their usual treatments and care throughout the study as clinically indicated, and will not receive any treatment delivered or funded as part of the trial. TAU may include both pharmacological (e.g. analgesic medication) and non-pharmacological treatment (e.g. physiotherapy).
Control group
Active

Outcomes
Primary outcome [1] 341938 0
Pain Severity
Timepoint [1] 341938 0
Baseline 20-weeks post randomisation (primary endpoint)
Secondary outcome [1] 449074 0
Pain Severity
Timepoint [1] 449074 0
Baseline, 12- and 52-weeks post randomisation
Secondary outcome [2] 449082 0
Depression symptoms
Timepoint [2] 449082 0
Baseline, 12-, 20-, and, 52-weeks post randomisation
Secondary outcome [3] 449084 0
Pain Disability
Timepoint [3] 449084 0
Baseline, 12-, 20-, and, 52-weeks post randomisation
Secondary outcome [4] 449085 0
Anxiety Symptoms
Timepoint [4] 449085 0
Baseline, 12-, 20-, and, 52-weeks post randomisation
Secondary outcome [5] 449086 0
Sleep Proroblems
Timepoint [5] 449086 0
Baseline, 12-, 20-, and, 52-weeks post randomisation
Secondary outcome [6] 449087 0
Quality of Life
Timepoint [6] 449087 0
Baseline, 12-, 20-, and, 52-weeks post randomisation
Secondary outcome [7] 449088 0
Emotion Dysregulation
Timepoint [7] 449088 0
Baseline, 12-, 20-, and, 52-weeks post randomisation
Secondary outcome [8] 449089 0
Patients Impression of Change
Timepoint [8] 449089 0
12-, 20-, and, 52-weeks post randomisation

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation schedule will be held by a person not involved in the trial and will not be accessible to other trial staff until the trial is completed. Allocation involves contacting the holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to one of the two groups in a 1:1 ratio. A statistician who is not involved in participant recruitment or assessment will use a random number generator to create a randomisation schedule, assigning each participant ID to one of the groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power Analysis:
The nominated sample is based on a sample size calculation conducted by statistician Dr Rob Herbert (NeuRA & UNSW). The trial is designed to detect an effect on pain severity (primary outcome) measured on the Brief Pain Inventory (BPI) of 1.0 point with a target Type I error rate (alpha) of 5%. A conservative estimate of the expected within-group, within-timepoint SD of the BPI is 2.0 (Norman-Nott et al., 2024). Thus, the provisional estimates of the standardised smallest worthwhile effect are (1 / 2 =) 0.5 for the BPI. The correlation of the outcome measure measured at adjacent time points was assumed to be 0.6, decaying by 0.1 at each time point. The primary outcome is assumed to be continuous and normally distributed. Power has been determined empirically by simulating 1,000 trial replications and determining the proportion of trial replications for which the null hypothesis of no treatment effect was rejected. With 1,000 replications, an estimated power of 90% has a 95% confidence interval that extends from 88.0% to 91.7%. Allowance has been made for loss to follow-up of 20% which involved inflation of the sample size by a factor of 1 / (1-0.2) = 1.25. Overall, a sample size of 104 per group (total 208) provides an 90% power to detect an effect of 1 point on the BPI with an alpha of 0.05, assuming a SD of 2.0, a correlation between adjacent timepoints of 0.6, and a loss to follow-up of 20%. We will include all randomised participants in the analyses (intention-to-treat).

Statistical analysis plan
A detailed statistical analysis plan will be developed without knowledge of the accruing results. A date-stamped version of the plan will be made publicly available. Key elements of the statistical analysis are described here.

Data management
A secure electronic data capture system will be used to capture the data and protect unauthorised access to trial data. Data quality will be monitored as the data accrue. Records will be kept of data queries and how data queries are resolved. Trial data will be kept for at least 15 years.

Estimands
The primary estimands are the average marginal causal effects (i.e., mean differences between the potential outcome under intervention and the potential outcome with the comparator) of the intention to provide the interventions on BPI-Pain Severity measured 20 weeks after randomisation in the trial population. As the objective is to assess the effects of intending to administer the interventions (a “treatment policy strategy”), outcome data from all trial participants will be included in the analysis, regardless of treatment-modifying events. That is, the primary analysis will be by intention to treat. The statistical analysis plan will describe methods used for dealing with missing data.

Primary analysis of efficacy
The estimate of effects will be obtained from a mixed effects linear regression model in which the dependent variable is the BPI-Pain Severity score, the fixed independent variables are a dummy coded variable for intervention, a dummy-coded factor variable for time, and the interactions between these variables. The model will have random intercepts for individuals. For the primary analysis of effectiveness, we will extract from the model estimates of effects on BPI-Pain Severity at 20 weeks using the “stratification” approach described by Morris et al (2022). Point estimates of the effects and their two-sided 95% confidence intervals will be reported. These will be supplemented with two-sided hypothesis tests.

Secondary analysis of efficacy
The secondary analyses will use the same methods as used in the primary analyses.

Other analyses
Further pre-specified exploratory analyses will be described in the statistical analysis plan.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/01/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
208
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319298 0
Government body
Name [1] 319298 0
Medical Research Future Fund, Department of Health and Aged Care.
Country [1] 319298 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Country
Australia
Secondary sponsor category [1] 321776 0
None
Name [1] 321776 0
Address [1] 321776 0
Country [1] 321776 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317876 0
The University of New South Wales Committee C
Ethics committee address [1] 317876 0
Ethics committee country [1] 317876 0
Australia
Date submitted for ethics approval [1] 317876 0
03/08/2025
Approval date [1] 317876 0
Ethics approval number [1] 317876 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142434 0
Prof Sylvia Gustin
Address 142434 0
UNSW Sydney, NeuroRecovery Research Hub, Level 1 BioLink Building, Sydney NSW 2052 Australia
Country 142434 0
Australia
Phone 142434 0
+61 413278336
Fax 142434 0
Email 142434 0
[email protected]
Contact person for public queries
Name 142435 0
Dr. Nell Norman-Nott
Address 142435 0
UNSW Sydney, NeuroRecovery Research Hub, Level 1 BioLink Building, Sydney NSW 2052 Australia
Country 142435 0
Australia
Phone 142435 0
+61 490802397
Fax 142435 0
Email 142435 0
[email protected]
Contact person for scientific queries
Name 142436 0
Dr. Nell Norman-Nott
Address 142436 0
UNSW Sydney, NeuroRecovery Research Hub, Level 1 BioLink Building, Sydney NSW 2052 Australia
Country 142436 0
Australia
Phone 142436 0
+61 490802397
Fax 142436 0
Email 142436 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• De-identified individual participant data will be made to interested researchers only upon reasonable request and once the
proposed research project has received separate ethics approval from a Human Research Ethics Committee

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data of published results will be made available upon reasonable request.

What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Request to the data custodian, the Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  [email protected]
Statistical analysis plan  [email protected]


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.