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Trial registered on ANZCTR


Registration number
ACTRN12613000428763
Ethics application status
Approved
Date submitted
3/04/2013
Date registered
16/04/2013
Date last updated
24/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Behavioural Therapy (BT) Sleep Intervention with Cognitive Components to Treat Insomnia in Rural NSW involving Practice Nurses: A Pilot Study
Scientific title
A Behavioural Therapy (BT) Sleep Intervention with Cognitive Components to Treat Insomnia in Rural NSW involving Practice Nurses: A Pilot Study
Secondary ID [1] 282200 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic insomnia 288719 0
Condition category
Condition code
Mental Health 289069 289069 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insomnia patients living in or near the Tamworth area will be referred into the study by their GP. Alternatively, patients may see a poster/flyer in the GP waiting room and contact the study coordinator directly. A total of 24 eligible and willing patients will be randomly assigned to either the sleep intervention group (N=12) or the wait-list control group (N=12).

Participants assigned to the sleep intervention group will be invited to undertake a sleep intervention following the completion of their baseline questionnaires, with no waiting period. The sleep intervention is led by a trained Practice Nurse and it is an evidence based behavioural therapy sleep intervention with cognitive components. It consists of 4 x 1.5 hour individual sessions with each session taking place once a fortnight over a period of 7 weeks. Sessions 1: will provide the patient with information about sleep. Session 2: will provide the patient with information about clinically proven effective behavioural treatments for insomnia. These include Stimulus Control Therapy, Sleep Restriction Therapy, Paradoxical Intention and Sleep Hygiene. A discussion about what interventions are most likely to work for a particular patient will be addressed in this session. Session 3: will be about increasing patient awareness about their behaviours and thought patterns. Barriers preventing patients from starting or maintaining changes will be discussed and motivation and confidence levels will be explored. Session 4: will consolidate the information presented during the course. Future individual sleep plans for patients will be explored and discussed.
Intervention code [1] 286813 0
Treatment: Other
Intervention code [2] 286961 0
Behaviour
Comparator / control treatment
Participants randomly assigned to the wait-list control group will receive treatment as per usual as well as receive booklets containing written information on relaxation strategies and the relationship between mood and sleep. After 3 months has elapsed from the completion date of their baseline questionnaires, participants in the wait-list control group will be offered the same sleep intervention as the treatment group.
Control group
Active

Outcomes
Primary outcome [1] 289177 0
Sleep Continuity measured by actigraphy and sleep diaries.
Five variables are used to define sleep continuity: Sleep Latency (SL), Frequency of Nocturnal Awakenings (FNA), Wake After Sleep Onset (WASO), Total Sleep Time (TST), and Sleep Efficiency (SE%)
Timepoint [1] 289177 0
Baseline, post- intervention, 3 and 6 months post-intervention
Primary outcome [2] 289281 0
Improved Total Sleep Time measured by sleep diaries and actigraphy
Timepoint [2] 289281 0
Baseline, post- intervention, 3 and 6 months post-intervention
Primary outcome [3] 293056 0
Insomnia symptom severity as measured by the Insomnia Severity Index (ISI)
Timepoint [3] 293056 0
Baseline, post- intervention, 3 and 6 months post-intervention
Secondary outcome [1] 301968 0
Mood measured by the Depression Anxiety Stress Scale (DASS) questionnaire
Timepoint [1] 301968 0
Baseline, post- intervention, 3 and 6 months post-intervention
Secondary outcome [2] 302150 0
Quality of Sleep measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Timepoint [2] 302150 0
Baseline, post- intervention, 3 and 6 months post-intervention
Secondary outcome [3] 310255 0
Fatigue levels as measured by the Fatigue Severity Scale
Timepoint [3] 310255 0
Baseline, post- intervention, 3 and 6 months post-intervention
Secondary outcome [4] 310256 0
Daytime sleepiness as measured by the Epworth Sleepiness Scale
Timepoint [4] 310256 0
baseline, post-intervention, 3 and 6 month post-intervention
Secondary outcome [5] 310257 0
sleep related beliefs as measured by the Dysfunctional Beliefs and Attitudes about Sleep
Timepoint [5] 310257 0
baseline, post-intervention, 3 and 6 month post-intervention
Secondary outcome [6] 310258 0
sleep-related quality of life impairment as measured by the Glasgow Sleep Impact Index (GSII)
Timepoint [6] 310258 0
baseline, post-intervention, 3 and 6 month post-intervention
Secondary outcome [7] 310259 0
Self efficacy as measured by the General Self-Efficacy Scale
Timepoint [7] 310259 0
baseline, post-intervention, 3 and 6 month post-intervention
Secondary outcome [8] 310260 0
health related quality of life as measured by the SF-36
Timepoint [8] 310260 0
baseline, post-intervention, 3 and 6 month post-intervention
Secondary outcome [9] 310261 0
Sleep effort as measured by the The Glasgow Sleep Effort Scale
Timepoint [9] 310261 0
baseline, post-intervention, 3 and 6 month post-intervention

Eligibility
Key inclusion criteria
Any patient (over 18 years) with chronic insomnia (i.e symptoms occurring at least 3 times per week which have been present for greater than one month) will be eligible unless meeting exclusion criteria listed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All patients will have been assessed by the General Practitioners in their area and any individual with a Major Depressive Disorder and/or psychotic disorder/ significant alcohol/drug related disorders, other major sleep disorders, shift workers or has insufficient English to understand and respond to this intervention will be excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation Method: It will be done individually using a randomisation list prepared ahead of time. This will be done on a 1:1 ratio in terms of either being assigned to the Intervention group or the Wait List control group. It will be done using permuted blocks of varying size with allocation concealment achieved by sequentially number opaque sealed envelopes.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2014
Actual
21/08/2014
Date of last participant enrolment
Anticipated
1/01/2016
Actual
13/01/2016
Date of last data collection
Anticipated
10/10/2016
Actual
10/10/2016
Sample size
Target
26
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286962 0
Government body
Name [1] 286962 0
Centre for Integrated Research and Understanding of Sleep -Seed Funding Grant
Country [1] 286962 0
Australia
Primary sponsor type
Government body
Name
Centre for Integrated Research and Understanding of Sleep - Seed Funding Grant
Address
431 Glebe Point Rd
Glebe NSW 2037
Country
Australia
Secondary sponsor category [1] 285822 0
None
Name [1] 285822 0
Address [1] 285822 0
Country [1] 285822 0
Other collaborator category [1] 278144 0
Government body
Name [1] 278144 0
New England Medicare Local
Address [1] 278144 0
Suite 3, 180 Peel Street, Tamworth NSW 2340
Country [1] 278144 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289037 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 289037 0
Research Development Office
RPAH Medical Centre
Suite 210A, 100 Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 289037 0
Australia
Date submitted for ethics approval [1] 289037 0
17/04/2013
Approval date [1] 289037 0
28/03/2014
Ethics approval number [1] 289037 0
HREC/13/RPAH/608

Summary
Brief summary
Insomnia is a common and distressing sleep disorder. Untreated insomnia is responsible for increasing health care utilisation through negatively impacting on mood (depression & anxiety), family and workplace behaviour which in turn increases a socioeconomic burden on the community (Ohayon 2002; Siebern & Manber 2010; Hilman et al., 2008). Cognitive Behavioural Therapy (CBT-i) is the most efficacious treatment for insomnia by enabling the individual to change current ineffective behaviours and challenge faulty beliefs about sleep (Morin et al., 2006). Effective behavioural sleep interventions include sleep restriction therapy (Edinger & Means, 2005) stimulus control therapy (Bootzin, 1972) paradoxical intention (Morin 1993) and sleep hygiene (Hauri, 1991). These behavioural sleep interventions have successful treatment outcomes when run by the equivalent of Practice Nurses in Scotland and do not require trained psychologists (Espie et al., 2001; Espie et al., 2007). Although CBTi has proven effectiveness, access to both sleep centres and professionals who are able to provide such services is limited in most major cities and is often absent in rural communities in Australia. More recently a “stepped care” model to treat insomnia has been proposed (Espie 2009). This model proposes a generic pyramid where the majority of patient care is undertaken at baseline with an evidence-based but less intense treatment intervention whilst “greater expertise” in both assessment and treatment is used towards the top step of the pyramid. This model has considerably validity in the treatment of insomnia patients using group CBTi which has an efficacious record in a number of different age groups and settings. For many rural families the cost of going to capital cities for an ongoing treatment intervention is not feasible. There are also the ongoing issues of social isolation and increased depression rates particularly in young men in rural communities. Treating insomnia symptoms is an effective first step to address these issues. Training Practice Nurses to undertake a predominantly Behavioural Therapy (BT) intervention will enable the provision of a treatment which is both easily accessible and has been shown to improve sleep and mood in most individuals. The primary aim of this project is to assess the outcomes of a BT intervention for insomnia when delivered by Nurse practitioners in a medical setting in rural NSW.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33980 0
A/Prof Delwyn Bartlett
Address 33980 0
Woolcock Institute of Medical Research PO Box M77 Missenden Road Camperdown NSW 2050
Country 33980 0
Australia
Phone 33980 0
+612 9114 0460
Fax 33980 0
+612 9114 0465
Email 33980 0
delwyn.bartlett@sydney.edu.au
Contact person for public queries
Name 17227 0
A/Prof Delwyn Bartlett
Address 17227 0
Woolcock Institute of Medical Research PO Box M77 Missenden Road Camperdown NSW 2050
Country 17227 0
Australia
Phone 17227 0
+612 9114 0460
Fax 17227 0
+612 9114 0465
Email 17227 0
delwyn.bartlett@sydney.edu.au
Contact person for scientific queries
Name 8155 0
A/Prof Delwyn Bartlett
Address 8155 0
Woolcock Institute of Medical Research PO Box M77 Missenden Road Camperdown NSW 2050
Country 8155 0
Australia
Phone 8155 0
+612 9114 0460
Fax 8155 0
+612 9114 0465
Email 8155 0
delwyn.bartlett@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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