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Does small-group sleep therapy improve sleep, pain and quality of life for people with chronic pain?

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001364662
Enrollment
18
Registered
2023-12-21
Start date
2023-07-18
Completion date
2024-03-20
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to determine the feasibility and effectiveness of a small-group 'Cognitive Behaviour Therapy for Insomnia' intervention for people with chronic pain who also have trouble sleeping. Participants from the Flinders Medical Centre Pain Management Unit will attend the small-group sessions with around 8 other people, once a week for six weeks, with four separate groups running. In this program, they will learn different ways to improve their sleep using sleep hygiene, stimulus control, sleep restriction, relaxation, and cognitive therapy. To determine how well the program works, researchers will measure participants' sleep, pain and quality of life prior to and immediately after the therapy, as well as 3 months later. If the program helps our participants, it could lead to more research to help others with similar problems.

Interventions

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

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).

Sponsors

The Flinders Medical Centre (Pain Management Unit, C/O Dr Amelia Searle)
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026