Health professional Administered Brief Insomnia Therapy (HABIT) trial
| ISRCTN | ISRCTN42499563 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42499563 |
| IRAS number | 238138 |
| Secondary identifying numbers | 37608; HTA 16/84/01, IRAS 238138 |
- Submission date
- 30/04/2018
- Registration date
- 31/05/2018
- Last edited
- 27/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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?
University of Oxford (UK)
Who is funding the study?
The Health Technology Assessment (HTA) Programme – National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Nargis Begum and Barbara Robinson
habit.study@phc.ox.ac.uk
Contact information
Scientific
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
| Phone | +44 (0)1865 617833 |
|---|---|
| habit.study@phc.ox.ac.uk |
Scientific
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
 ORCID ID |
0000-0002-9581-5311 |
|---|---|
| Phone | +44 (0)1865 618675 |
| simon.kyle@ndcn.ox.ac.uk |
Public
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
| Phone | +44 (0)1865 617833 |
|---|---|
| habit.study@phc.ox.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | ISRCTN42499563_PIS_v2.0_11July2018.pdf |
| 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 |
| Study 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(s) | Yorkshire and The Humber – Bradford Leeds REC, 14/05/2018, ref: 18/YH/0153 |
| Condition | Insomnia |
| 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 |
| 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 | Current secondary outcome measures as of 29/01/2021: 1. The effect of SRT+SH versus SH on health-related quality of life (HRQoL) measured using the SF-36 questionnaire (Mental component summary [MCS] score and Physical component summary [PCS] score) at baseline, 3, 6 and 12 months post-randomization 2. The effect of SRT+SH versus SH on subjective sleep. 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-randomization 3. The effect of SRT+SH versus SH on object estimates of sleep. Actigraphy-recorded sleep over 7 nights (SOL; WASO; SE; TST) at baseline, 6 and 12 months post-randomization 4. The effect of SRT+SH versus SH on patient-generated quality of life. Self-rated quality of life using the Glasgow Sleep Impact Index [GSII Ranks 1,2,3] at baseline, 3, 6 and 12 months post-randomization 5. The effect of SRT+SH versus SH on depressive symptoms assessed by self-rated depressive symptoms severity measured using the Patient Health Questionnaire (PHQ-9) at baseline, 3, 6 and 12 months post-randomization. 6. The effect of SRT+SH versus SH on work productivity measured by the self-rated work productivity and activity impairment questionnaire (WPAI) at baseline, 3, 6 and 12 months post-randomization 7. The effect of SRT+SH versus SH on hypnotic medication use assessed by the use of prescribed hypnotics (quantified from 7-day diary) at baseline, 6 and 12 months post-randomization 8. The effect of SRT+SH versus SH on the use of other prescribed sleep-promoting medications measured by the use of other prescribed sleep-promoting medications (e.g., sedative antidepressants, antihistamines, antipsychotics, melatonin) quantified from 7 day diary, at baseline, 6 and 12 months post-randomization 9. The effect of SRT+SH versus SH on pre-sleep arousal and sleep effort measured by the pre-sleep arousal scale (PSAS) and Glasgow sleep effort scale (GSES) at baseline, 3, 6 and 12 months post-randomization 10. 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-randomization 11. Intervention delivery, fidelity and acceptability assessed using semi-structured interviews with trial participants, nurses, GPs, and practice managers. The number of appointments attended/received by participants, fidelity appraisal of recorded consultations, and adherence to prescribed sleep window (from sleep diary), are collected throughout the trial 12. Adverse events between the groups assessed using a questionnaire at baseline, 3, 6, and 12 months _____ Previous secondary outcome measures as of 24/08/2020: 1. The effect of SRT+SH versus SH on 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-randomization 2. The effect of SRT+SH versus SH on subjective sleep. 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-randomization 3. The effect of SRT+SH versus SH on object estimates of sleep. Actigraphy-recorded sleep over 7 nights (SOL; WASO; SE; TST) at baseline, 6 and 12 months post-randomization 4. The effect of SRT+SH versus SH on patient-generated quality of life. Self-rated quality of life using the Glasgow Sleep Impact Index [GSII Ranks 1,2,3] at baseline, 3, 6 and 12 months post-randomization 5. Tthe effect of SRT+SH versus SH on depressive symptoms assessed by self-rated depressive symptoms severity measured using the Patient Health Questionnaire (PHQ-9) at baseline, 3, 6 and 12 months post-randomization. 6. The effect of SRT+SH versus SH on work productivity measured by the self-rated work productivity and activity impairment questionnaire (WPAI) at baseline, 3, 6 and 12 months post-randomization 7. The effect of SRT+SH versus SH on hypnotic medication use assessed by the use of prescribed hypnotics (quantified from 7-day diary) at baseline, 6 and 12 months post-randomization 8. The effect of SRT+SH versus SH on the use of other prescribed sleep-promoting medications measured by the use of other prescribed sleep-promoting medications (e.g., sedative antidepressants, antihistamines, antipsychotics, melatonin) quantified from 7 day diary, at baseline, 6 and 12 months post-randomization 9. The effect of SRT+SH versus SH on pre-sleep arousal and sleep effort measured by the pre-sleep arousal scale (PSAS) and Glasgow sleep effort scale (GSES) at baseline, 3, 6 and 12 months post-randomization 10. 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-randomization 11. Intervention delivery, fidelity and acceptability assessed using semi-structured interviews with trial participants, nurses, GPs, and practice managers. The number of appointments attended/received by participants, fidelity appraisal of recorded consultations, and adherence to prescribed sleep window (from sleep diary), are collected throughout the trial 12. Adverse events between the groups assessed using a questionnaire at baseline, 3, 6, and 12 months _____ Previous secondary outcome measures as of 19/02/2020: 1. 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-randomization 2. The effect of SRT+SH versus SH on subjective sleep. 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-randomization 3. The effect of SRT+SH versus SH on object estimates of sleep. Actigraphy-recorded sleep over 7 nights (SOL; WASO; SE; TST) at baseline, 6 and 12 months post-randomization 4. The effect of SRT+SH versus SH on patient-generated quality of life. Self-rated quality of life using the Glasgow Sleep Impact Index [GSII Ranks 1,2,3] at baseline, 3, 6 and 12 months post-randomization 5. Tthe effect of SRT+SH versus SH on depressive symptoms assessed by self-rated depressive symptoms severity measured using the Patient Health Questionnaire (PHQ-9) at baseline, 3, 6 and 12 months post-randomization. 6. The effect of SRT+SH versus SH on work productivity measured by the self-rated work productivity and activity impairment questionnaire (WPAI) at baseline, 3, 6 and 12 months post-randomization 7. The effect of SRT+SH versus SH on hypnotic medication use assessed by the use of prescribed hypnotics (quantified from 7-day diary) at baseline, 6 and 12 months post-randomization 8. The effect of SRT+SH versus SH on the use of other prescribed sleep-promoting medications measured by the use of other prescribed sleep-promoting medications (e.g., sedative antidepressants, antihistamines, antipsychotics, melatonin) quantified from 7 day diary, at baseline, 6 and 12 months post-randomization 9. The effect of SRT+SH versus SH on pre-sleep arousal and sleep effort measured by the Pre-sleep arousal scale (PSAS) and Glasgow sleep effort scale (GSES) at baseline, 6 and 12 months post-randomization 10. 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-randomization 11. Intervention delivery, fidelity and acceptability assessed using semi-structured interviews with trial participants, nurses, GPs, and practice managers. The number of appointments attended/received by participants, fidelity appraisal of recorded consultations, and adherence to prescribed sleep window (from sleep diary), are collected throughout the trial 12. Adverse events between the groups assessed using a questionnaire at baseline, 3, 6, and 12 months Previous 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 study start date | 01/10/2017 |
| Overall study end date | 06/04/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | A minimum of 628 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. |
| Total final enrolment | 642 |
| Participant inclusion criteria | Current participant inclusion criteria as of 19/02/2020: 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 6. Registered at a GP practice taking part in the trial Previous 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 exclusion criteria | Current participant exclusion criteria as of 19/02/2020: 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/ Mild Cognitive Impairment (MCI) 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 10. Life expectancy of <2 years 11. Another person in the same household participates in this trial Previous exclusion criteria as of 17/09/2019: 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/ Mild Cognitive Impairment (MCI) 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 10. Life expectancy of < 2 years Previous 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 | 31/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Radcliffe Primary Care Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
Health Services Research and Primary Care
Manchester
M13 9PL
United Kingdom
Brayford Pool
Lincoln
LN6 7TS
United Kingdom
Sponsor information
University/education
Clinical Trials and Research Governance team (CTRG)
Joint Research Office
1st floor, Boundary Brook House
Churchill Drive, Headington
Oxford
OX3 7LQ
England
United Kingdom
| ctrg@admin.ox.ac.uk | |
| Website | https://researchsupport.admin.ox.ac.uk/ctrg |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v2.0 | 11/07/2018 | 21/08/2018 | No | Yes |
| Participant information sheet | version v3.0 | 29/07/2019 | 17/09/2019 | No | Yes |
| Participant information sheet | version V4.0 | 20/12/2019 | 18/02/2020 | No | Yes |
| Protocol file | version V5.0 | 20/12/2019 | 18/02/2020 | No | No |
| Protocol article | protocol | 04/03/2020 | 15/02/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 10/08/2023 | 14/08/2023 | Yes | No | |
| Results article | 01/08/2024 | 27/08/2024 | Yes | No |
Additional files
- ISRCTN42499563_PIS_v2.0_11July2018.pdf
- Uploaded 21/08/2018
- ISRCTN42499563_PIS_v3.0_29Jul19.pdf
- Uploaded 17/09/2019
- ISRCTN42499563_PIS_V4.0_20Dec2019.pdf
- Uploaded 18/02/2020
Editorial Notes
27/08/2024: Publication reference added.
14/08/2023: Publication reference added.
13/01/2023: The intention to publish date has been changed from 31/01/2023 to 01/05/2023.
02/11/2022: The intention to publish date was changed from 30/09/2022 to 31/01/2023.
11/04/2022: The intention to publish date has been changed from 06/04/2022 to 30/09/2022.
05/05/2021: The intention to publish date was changed from 01/04/2022 to 06/04/2022.
04/05/2021: The overall trial end date has been changed from 01/05/2021 to 06/04/2021.
06/04/2021: The overall trial end date was changed from 01/09/2021 to 01/05/2021.
01/04/2021: The overall trial end date was changed from 01/04/2021 to 01/09/2021.
15/02/2021: Publication reference added.
29/01/2021: The secondary outcome measures were changed.
07/12/2020: The protocol (not peer reviewed) Version 6.0, 05 August 2020 was removed as it was added in error.
13/11/2020: Uploaded protocol (not peer reviewed) Version 6.0, 05 August 2020.
24/08/2020: The secondary outcome measures have been changed.
14/04/2020: The total final enrolment number has been added from the reference.
18/03/2020: The following changes were made to the trial record:
1. The target number of participants was changed from '588' to 'a minimum of 628'.
2. The recruitment end date was changed from 28/02/2020 to 31/03/2020.
19/02/2020: The following changes have been made:
1. The secondary outcome measures have been updated.
2. The participant inclusion criteria have been updated.
3. The participant exclusion criteria have been updated.
18/02/2020: The following changes have been made:
1. The participant information sheet has been uploaded.
2. The protocol version 5.0 as of 20th December 2019 (not peer reviewed) has been uploaded.
12/02/2020: The IRAS number has been added.
11/02/2020: The recruitment end date has been changed from 01/01/2020 to 28/02/2020.
13/01/2020: Internal review.
17/09/2019: The following changes were made:
1. Version 3.0 of the participant information sheet was uploaded.
2. The recruitment end date was updated from 01/01/2020 to 01/03/2020.
3. The participant exclusion criteria was updated.
22/03/2019: The condition was updated from "Specialty: Primary Care, Primary sub-specialty: Neurological disorders; UKCRC code/ Disease: Insomnia disorders" to "Insomnia".
27/12/2018: Indrani Manoharan has been removed as the trial contact and Nargis Begum and Barbara Robinson added. The plain English summary has been updated accordingly.
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.
