Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001364662
Ethics application status
Approved
Date submitted
6/11/2023
Date registered
21/12/2023
Date last updated
21/12/2023
Date data sharing statement initially provided
21/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does small-group sleep therapy improve sleep, pain and quality of life for people with chronic pain?
Scientific title
Sleeping well with persistent pain: Evaluating the feasibility and effectiveness of cognitive-behavioural therapy for insomnia regarding sleep, pain, and quality of life for individuals with chronic pain
Secondary ID [1] 310880 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic sleep disturbance 331943 0
Chronic pain 331944 0
Condition category
Condition code
Public Health 328674 328674 0 0
Health service research
Mental Health 328675 328675 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CBTi intervention titled 'sleeping well with persistent pain' will comprise 6 x 1hr small-group sessions (held once weekly), with approximately 7 participants per group. These sessions are held face-to-face in a group room at our Pain Unit clinic.

Group content is guided by Tang’s CBTi for Chronic Pain protocol (2022: CBT-I Protocol for Insomnia Co-morbid with Chronic Pain. Cognitive-Behavioural Therapy For Insomnia (CBT-I) Across The Life Span: Guidelines and Clinical Protocols for Health Professionals). The intervention will include key elements of CBTi; sleep hygiene, stimulus control, sleep restriction, relaxation, and cognitive therapy. Participants receive a treatment manual with all study materials, as well as space to record individualised treatment plans, and weekly homework tasks and progress.

Two facilitators are present at each intervention session, to help ensure participants are kept engaged. Facilitators are one provisional and one registered psychologist, trained in CBTi, and completing a combined Masters and PhD (Clinical Psychology).

During all 6 weeks of the intervention, group participants will be required to use wrist-based actigraphy devices to monitor their sleep parameters (including total sleep time, sleep onset latency, wake after sleep onset), and this information will be used to adapt the treatment type/degree offered during the subsequent group session. Participants will also supplement this information by completing detailed sleep diaries for the entire 6 weeks of the intervention. During each of the 6 CBTi sessions, participants will also complete an 8-item measure of excessive daytime sleepiness, the Epworth Sleepiness Scale (ESS). The information gained from these scales will help the group facilitators to individualise and then progressively adapt the treatment approach for each participant throughout the 6-week group. Additionally, participants will complete the 10-item Pain Related Beliefs and Attitudes about Sleep (PBAS) scale on paper in the first and last sessions, for therapeutic reasons - to more closely monitor participants' progress/response to treatment, and reflect any progress back to participants, and provide a more detailed discharge letter and suggested next steps to GPs.

Session attendance is recorded by the facilitators, and non-attending participants are followed up via phone call to determine the reason for non-attendance.

Patients indicate their initial interest to hear more about the study to their Pain Unit doctor. Then, at the point of attempted recruitment by the study coordinator, participants choose to be allocated to the intervention (CBTi) condition (this is the default option). Patients who decline to participate in the intervention group after contact by the study coordinator (perhaps due to other commitments, needing to travel long distances, not liking group therapy) are offered participation in the control condition (treatment as usual, and simply completing outcome measures at three timepoints).
Intervention code [1] 327315 0
Treatment: Other
Comparator / control treatment
When our research team first speaks to interested patients about the study, some patients will decline due to logistical reasons such as distance from the Pain Unit, and other afternoon commitments clashing with the treatment. It is these patients that will be offered the opportunity to be a part of the control condition. Those voluntarily allocated to the treatment-as-usual control condition will simply attend their usual healthcare appointments and treatments during the study period. After data collection finishes, control participants will be invited to attend a 1hr sleep education seminar which is regularly run at the Pain Unit, covering basic information about ‘normal’ sleep, the relationship between sleep, health, and pain, and strategies to improve sleep.
Control group
Active

Outcomes
Primary outcome [1] 336477 0
Insomnia symptoms
Timepoint [1] 336477 0
Baseline, week prior to treatment start, treatment mid-point i.e. after session 3, treatment end-point i.e. after session 6, 3-month follow-up (and similar time-points for control participants)
Primary outcome [2] 336478 0
Pain severity and interference
Timepoint [2] 336478 0
Baseline, week prior to treatment start, treatment mid-point i.e. after session 3, treatment end-point i.e. after session 6, 3-month follow-up (and similar time-points for control participants)
Primary outcome [3] 336479 0
Quality of life
Timepoint [3] 336479 0
Baseline, week prior to treatment start, treatment mid-point i.e. after session 3, treatment end-point i.e. after session 6, 3-month follow-up (and similar time-points for control participants)
Secondary outcome [1] 428533 0
Participant satisfaction
Timepoint [1] 428533 0
During the final treatment session (treatment participants only)
Secondary outcome [2] 428534 0
Pain-related beliefs about sleep
Timepoint [2] 428534 0
During the first and last treatment sessions (treatment participants only)
Secondary outcome [3] 428594 0
Sleep efficiency
Timepoint [3] 428594 0
Week prior to treatment start (i.e., baseline), treatment mid-point (i.e. after session 3), treatment end-point (i.e., at session 6), and 3-month follow-up
Secondary outcome [4] 428597 0
Sleep efficiency - estimated subjectively by patient report
Timepoint [4] 428597 0
Week prior to treatment start (i.e., baseline), treatment mid-point (i.e. after session 3), treatment end-point (i.e., at session 6), and 3-month follow-up
Secondary outcome [5] 428600 0
Several feasibility measures: interest, recruitment, participation, drop-out and completion rates.
Timepoint [5] 428600 0
Throughout the project recruitment and participation period - July 2023 to August 2024.
Secondary outcome [6] 428601 0
attendance rates
Timepoint [6] 428601 0
Throughout the therapy period - September 2023 to May 2024.
Secondary outcome [7] 429918 0
self-reported barriers to attendance
Timepoint [7] 429918 0
baseline, and throughout the 6-week treatment
Secondary outcome [8] 429919 0
homework/therapy adherence.
Timepoint [8] 429919 0
During the 6-week treatment period

Eligibility
Key inclusion criteria
A patient at the Flinders Medical Centre Pain Management Unit (Pain Unit)
Experiencing chronic pain (3 months or more)
Experiencing chronic self-reported sleep disturbance (for 3 months or more)
Have had a medical appointment at the Pain Unit during the recruitment period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Been at the Pain Unit continuously for more than a year (ok if have been discharged then re-referred later)
Currently undergoing any Allied Health treatment at the Pain Unit
Actively suicidal
Unstable mental health
Needing an interpreter

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We have very consciously chosen a non-randomised trial for our study design, with the only viable alternative being a one-group (no control) study. While we may expect some between-group differences (e.g., in motivation) as a result of this non-randomised allocation, we would be unable to feasibly recruit enough participants for each CBTi group within each recruitment period if we also needed to recruit the same number of participants (i.e., doubling the necessary sample size) to be randomly-allocated to the control. We needed to focus on maximising the size of the treatment condition given the gradual flow of new patients through our clinic, and did not want to jeopardise this by splitting all of our interested participants into a treatment and a control group. Given there are already 12 randomised controlled trials published in this area that attest to the superiority of CBTi compared to control for chronic pain patients, our chief aim is not to demonstrate the same (which would necessitate randomisation). Our main concern is whether our patients would benefit, and how this treatment would fit into our Pain Unit's existing model of care – thus requiring us to maximise the treatment group. We also appreciate that it may be difficult to recruit for this control condition, but if we are unable to recruit sufficient numbers, we will simply analyse and report the treatment group data, which will be enough to achieve our aims. We hope to use the findings of the present research to leverage future research funding for a randomised controlled trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/07/2023
Date of last participant enrolment
Anticipated
20/03/2024
Actual
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
36
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25803 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 41629 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 315140 0
Charities/Societies/Foundations
Name [1] 315140 0
The Hospital Research Foundation
Country [1] 315140 0
Australia
Funding source category [2] 315160 0
Charities/Societies/Foundations
Name [2] 315160 0
The Flinders Foundation
Country [2] 315160 0
Australia
Primary sponsor type
Hospital
Name
The Flinders Medical Centre (Pain Management Unit, C/O Dr Amelia Searle)
Address
Flinders Drive Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 317159 0
University
Name [1] 317159 0
Flinders University (School of Psychology)
Address [1] 317159 0
University Drive, Bedford Park SA 5042
Country [1] 317159 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314078 0
SALHN Human Research Ethics Committee
Ethics committee address [1] 314078 0
Ethics committee country [1] 314078 0
Australia
Date submitted for ethics approval [1] 314078 0
31/01/2023
Approval date [1] 314078 0
11/04/2023
Ethics approval number [1] 314078 0

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

Contacts
Principal investigator
Name 130330 0
Dr Peter Herriot
Address 130330 0
C/O Flinders Medical Centre PMU, Flinders Drive, Bedford Park SA 5042
Country 130330 0
Australia
Phone 130330 0
+61 882045499
Fax 130330 0
Email 130330 0
[email protected]
Contact person for public queries
Name 130331 0
Amelia Searle
Address 130331 0
C/O Flinders Medical Centre PMU, Flinders Drive, Bedford Park SA 5042
Country 130331 0
Australia
Phone 130331 0
+61 882044016
Fax 130331 0
Email 130331 0
[email protected]
Contact person for scientific queries
Name 130332 0
Amelia Searle
Address 130332 0
C/O Flinders Medical Centre PMU, Flinders Drive, Bedford Park SA 5042
Country 130332 0
Australia
Phone 130332 0
+61 882044016
Fax 130332 0
Email 130332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20825Study protocol  [email protected]
20826Informed consent form  [email protected]
20827Ethical approval  [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.