Condition category
Mental and Behavioural Disorders
Date applied
30/04/2018
Date assigned
31/05/2018
Last edited
21/08/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Insomnia refers to persistent problems with falling asleep or staying asleep. Insomnia can have a significant effect on health and daily life. For example, it reduces the ability to concentrate, lowers mood and increases the risk of developing mental and physical illness. The best treatment for insomnia is a psychological therapy called cognitive-behavioural therapy (CBT), which involves supporting people with insomnia to improve their sleep behaviours and sleep-related thoughts. However, access to CBT in the UK is limited and there are not enough trained therapists to help the large number of poor sleepers (up to 10% of the adult population). The aim of this study is to test if a brief version of CBT called sleep restriction therapy (SRT), delivered by nurses working in GP practices, can help people with insomnia regain a normal sleep pattern.

Who can participate?
Patients aged 18 and over with insomnia

What does the study involve?
Participants are assigned, by chance, to one of two treatment groups. These groups will be either (1) sleep restriction therapy and sleep hygiene advice or (2) sleep hygiene advice only. Sleep restriction therapy involves meeting with a nurse for four weekly sessions. The nurse will support the patient to follow a new nightly sleep schedule over this four-week period. Sleep hygiene involves receiving a booklet with advice on how to improve sleep. Participants are asked to complete a number of questionnaires to measure their sleep, quality of life and daytime functioning before treatment, and also at 3, 6 and 12 months after treatment begins.

What are the possible benefits and risks of participating?
Participants may benefit from improved sleep and will also contribute to research which may help develop better treatments for people experiencing insomnia. There are no known serious side effects from taking part in this study, but any change in sleep patterns may be associated with a short-term increase in sleepiness. If participants feel sleepy during the study they are advised to avoid activities that require a high degree of vigilance, such as driving or operating heavy machinery. All participants are reimbursed after each completed visit. This takes the form of vouchers; £5 at baseline, £10 at 3 months, £15 at 6 months, and £10 at 12 months. Participants (sleep restriction therapy and sleep hygiene group only) also receive a voucher for participation in interviews as part of the process evaluation (£10 voucher).

Where is the study run from?
1. University of Oxford
2. University of Manchester
3. University of Lincoln

Who is funding the study?
The Health Technology Assessment (HTA) Programme – National Institute for Health Research (NIHR)

Who is the main contact?
Dr Indrani Manoharan
habit.study@phc.ox.ac.uk

Trial website

https://www.phc.ox.ac.uk/research/participate/habitstudy

Contact information

Type

Scientific

Primary contact

Dr Indrani Manoharan

ORCID ID

Contact details

Primary Care Clinical Trials Unit
Nuffield Department of Primary Care Health Sciences
University of Oxford
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
+44 (0)1865 289 591
habit.study@phc.ox.ac.uk

Type

Scientific

Additional contact

Dr Simon D. Kyle

ORCID ID

http://orcid.org/0000-0002-9581-5311

Contact details

Sleep and Circadian Neuroscience Institute (SCNi)
Nuffield Department of Clinical Neurosciences
Sir William Dunn School of Pathology
University of Oxford
South Parks Road
Oxford
OX1 3RE
United Kingdom
+44 (0)1865 618675
simon.kyle@ndcn.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

37608; HTA 16/84/01

Study information

Scientific title

A pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy (SRT) for insomnia disorder to sleep hygiene (SH) in primary care

Acronym

HABIT

Study hypothesis

Systematic review evidence shows that a single component of cognitive-behavioural therapy (CBT) for insomnia, call sleep restriction therapy (SRT), is clinically efficacious. We aim to test whether nurse-delivered sleep restriction therapy (SRT) for insomnia disorder in UK primary care is both clinically and cost-effective.

Ethics approval

Yorkshire and The Humber – Bradford Leeds REC, 14/05/2018, ref: 18/YH/0153

Study design

Randomised; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Primary Care, Primary sub-specialty: Neurological disorders; UKCRC code/ Disease: Insomnia disorders

Intervention

Participants will be randomised (1:1) to one of the two intervention groups to receive either SRT+SH or SH, using a validated web-based randomisation programme (Sortition), with a non-deterministic minimisation algorithm to ensure site, use of prescribed sleep promoting medication (yes/no), age (18-65 yrs vs. > 65yrs), sex, baseline insomnia severity (ISI score <22 vs. 22-28) and depression symptom severity (PHQ-9 score <10 vs. 10-27) are balanced across the two groups.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Self-rated insomnia severity using the insomnia severity index (ISI) questionnaire collected at baseline, 3, 6 and 12 months post randomization. Primary outcome is at 6 months.

Secondary outcome measures

1. To compare the effect of SRT+SH versus SH on insomnia severity using self-rated health-related quality of life (HRQoL) measured using the SF-36 questionnaire (Total Score, Mental component summary [MCS] score and Physical component summary [PCS] score) at baseline, 3, 6 and 12 months post-randomisation.
2. Subjective sleep recorded over 7 nights using the consensus sleep diary (CSD)
(sleep-onset latency [SOL]; wake-time after sleep onset [WASO]; sleep efficiency [SE]; total sleep time [TST]; sleep quality [SQ]) at baseline, 6 and 12 months post-randomisation.
3. Actigraphy-recorded sleep over 7 nights (SOL; WASO; SE; TST) at baseline, 6 and 12 months post-randomisation.
4. Self-rated quality of life using the Glasgow Sleep Impact Index [GSII Ranks 1,2,3] at baseline, 3, 6 and 12 months post-randomisation.
5. Self-rated depressive symptoms severity using the Patient Health Questionnaire (PHQ-9) at baseline, 3, 6 and 12 months post-randomisation.
6. Self-rated work productivity and activity impairment questionnaire (WPAI) at baseline, 3, 6 and 12 months post-randomisation.
7. Use of prescribed hypnotics (quantified from 7-day diary) at baseline, 6 and 12 months post-randomisation.
8. Use of other prescribed sleep-promoting medications (e.g., sedative antidepressants, anti-histamines, antipsychotics, melatonin) quantified from 7 day diary, at baseline, 6 and 12 months post-randomisation.
9. Incremental cost-effectiveness from both NHS and societal perspectives measured using trial records (time and number of nurse-led appointments), practice records (medications; baseline and 12 months only), Client Service Receipt Inventory (self-reported service use, medications), Insomnia Severity Index, WPAI, EQ-5D-3L (QALY) at baseline, 3, 6 and 12 months post-randomisation.
10. Intervention delivery, fidelity and acceptability assessed using semi-structured interviews with 1) trial participants; 2) nurses 3) GPs and 4) practice managers; number of appointments attended/received by participants; fidelity appraisal of recorded consultations; and adherence to prescribed sleep window (from sleep diary), throughout the trial.
11. Adverse events between the groups assessed using questionnaire at baseline, 3, 6, and 12 months.

Overall trial start date

01/10/2017

Overall trial end date

01/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Screen positive for insomnia symptoms on the Sleep Condition Indicator (SCI) questionnaire AND meet criteria for insomnia disorder according to DSM-5 (American Psychiatric Association) on structured checklist review
3. Sleep efficiency < 85% over the past month
4. Age ≥18 years
5. Able to attend appointments during baseline and 4-week intervention (both face-to-face at the practice and over the phone) and adhere to study procedures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

588 participants will be recruited from three centres in the UK. Participants will be randomised to one of two groups. In addition, we plan to recruit 15 practice nurses and 15 GPs or practice managers for semi-structured qualitative interviews as part of our process evaluation.

Participant exclusion criteria

Current exclusion criteria as of 21/08/2018:
1. Pregnant/pregnancy planning in the next 6 months
2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) OR screen “positive” on screening
3. Dementia
4. Epilepsy
5. Psychosis (schizophrenia, bipolar disorder)
6. Current suicidal ideation with intent OR attempted suicide within past 2 months
7. Currently receiving cancer treatment OR planned major surgery during treatment phase
8. Night, evening, early morning or rotating shift-work
9. Currently receiving psychological treatment for insomnia from a health professional or taking part in an online treatment programme for insomnia.
10. Life expectancy of <2 years

Previous exclusion criteria:
1. Pregnant/pregnancy planning in the next 6 months
2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) OR screen “positive” on screening
3. Dementia
4. Epilepsy
5. Psychosis (schizophrenia, bipolar disorder)
6. Current suicidal ideation with intent OR attempted suicide within past 2 months
7. Currently receiving cancer treatment OR planned major surgery during treatment phase
8. Night, evening, early morning or rotating shift-work
9. Trans-meridian travel planned during the baseline assessments or for > 3 nights during treatment phase
10. Currently receiving psychological treatment for insomnia from a health professional
11. Life expectancy of < 2 years

Recruitment start date

01/08/2018

Recruitment end date

01/01/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Primary Care Clinical Trials Unit Radcliffe Primary Care Building Radcliffe Observatory Quarter Woodstock Road
Oxford
OX2 6GG
United Kingdom

Trial participating centre

University of Manchester
Division of Population Health Health Services Research and Primary Care
Manchester
M13 9PL
United Kingdom

Trial participating centre

University of Lincoln
School of Health and Social Care Brayford Pool
Lincoln
LN6 7TS
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance team (CTRG)
Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7LQ
United Kingdom
-
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

https://researchsupport.admin.ox.ac.uk/ctrg

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trialists will publish their primary findings (on clinical and cost -effectiveness of SRT) in high-impact, peer reviewed journals. They will make their primary findings open access so they can be accessed by the widest number of people possible, including policy-makers and members of the public. They will publish additional important journal outputs in relation to process evaluation and secondary, exploratory moderator analyses. They will send trial participants a summary of study outcomes and present their findings at national (e.g. British Sleep Society, Society for Academic Primary Care), international (e.g. Sleep, North American Primary Care Research Group) and practitioner (e.g. RCGP) conferences.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Simon Kyle (simon.kyle@ndcn.ox.ac.uk). Other data sharing details will become available when the study has all the required approvals in place.

Intention to publish date

01/04/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/08/2018: The following changes were made to the trial record: 1. The participant information sheet has been uploaded. 2. The exclusion criteria were updated. 3. The recruitment start date was changed from 01/07/2018 to 01/08/2018. 01/06/2018: Internal review.