Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Niroshan Siriwardena


Contact details

Professor of Primary Care
University of Lincoln
Faculty of Health
Life & Social Sciences
University of Lincoln
Brayford Pool
United Kingdom
+44 (0)1522 886939

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

Sleep problems are common, affecting two fifths of the population. Poor sleep (insomnia) is linked with psychological problems such as depression and physical problems such as high blood pressure, weight gain and heart disease. Many of those affected seek help from GPs whose response is often limited to sleep hygiene advice (a bedtime routine avoiding caffeine, alcohol, cigarettes or other stimulants) or prescription of sleeping pills (hypnotics) neither of which has been shown to be effective in the long term. Drugs for sleep difficulties are ineffective long term and probably do more harm than good, particularly in the elderly. Psychological/behavioural methods for managing sleep problems, termed cognitive behavioural therapy for insomnia (CBTi) have been shown to be effective and cost-effective when delivered by specialists but have not been fully evaluated in a general practice setting where they are most likely to be needed and most appropriately delivered.

Education for primary care teams in problem focused therapy for patients presenting to primary care with insomnia leads to better sleep outcomes for patients compared to treatment as usual with sleep hygiene up to three months from the beginning of treatment.

Ethics approval

The North Nottingham Local Research Ethics Committee, approval received on the 16th September 2008 (ref: 08/H0406/128).

Study design

Cluster randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.




We will undertake a pilot cluster randomised controlled trial (RCT) in which general practices are the unit of randomisation and where data will be collected from patients. Recruited general medical practices will be randomised to one of two arms; intervention consisting of education of primary care teams to use problem focused therapy for insomnia comprising sleep assessment tools (sleep diaries and Insomnia Severity Index) and modified cognitive behavioural therapy for insomnia (mCBTi); or a control arm using treatment as usual (TAU).

Patients will be involved in the study for a total of 13 weeks. Study outcomes will be measured at baseline, 4 weeks, 8 weeks and 13 weeks. Follow-up assessments will be performed using a telephone call at 2 weeks after the first treatment and self-completed postal questionnaires at all other timepoints. Non-responders will be telephoned 1 week after mailing the follow-up questionnaire on up to two occasions and posted a replacement questionnaire with a reminder letter if there is still no response at 2 weeks.

Please use the following contact details to request a patient information sheet:
Miss Tanefa Apekey
Research Assistant
REST Project
Lincolnshire Teaching PCT
Cross O'Cliff Court
Bracebridge Heath
Lincoln LN4 2HN
Tel: +44 (0)1522 515406

Intervention type



Not Specified

Drug names

Primary outcome measures

Global sleep quality as measured by PSQI at 0, 4, 8 and 13 weeks.

Secondary outcome measures

Measured at 0, 4, 8 and 13 weeks:
1. The effect of the intervention on sleep outcome measures assessed with PSQI and sleep diaries:
1.1. Self reported sleep onset latency (SOL): how long it takes to fall asleep
1.2. Wake time after sleep onset (WASO): total hours awake at night after one has fallen asleep
1.3. Total time in bed (TIB)
1.4. Sleep efficiency (SE). Sleep efficiency, expressed as a percentage, is calculated as follows: SE = (100- [(SOL + WASO/TIB) x 100])
2. Daytime sleepiness (Epworth Sleepiness Scale)
3. Anxiety and depression using the generic Beck Depression Inventory
4. Health-related quality of life using EuroQol EQ-5D
5. Frequency of use and mean dose of hypnotic medication

Patients will also keep a Data Record Book (DRB) to record any adverse effects that participants might experience during the treatment period.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. At least 18 years old, either sex
2. Difficulty initiating and/or maintaining sleep for one month or more verified by Pittsburgh Sleep Quality Index (PSQI) score of greater than or equal to 5
3. New presentations with insomnia and existing patients on long term hypnotics
4. Points 1 - 3 above and sleep disrupted by painful conditions
5. Points 1 - 3 above and moderate/mild depression measured by the Beck Depression Inventory (BDI) (score 11 - 30)

Participant type


Age group




Target number of participants

80 patients recruited from 4 general practices (20 patients per practice)

Participant exclusion criteria

1. Current or previous illicit substance or alcohol abuse
2. Pregnant or planning pregnancy in the next 12 months
3. Psychotic illness and severe depression defined by a BDI score greater than or equal to 31
4. Documented or active symptoms of sleep disruptive comorbid conditions, e.g. restless legs syndrome and any type of parasomnia
5. Obstructive sleep apnoea
6. Terminal illness
7. Inability to consent

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Professor of Primary Care, University of Lincoln
United Kingdom

Sponsor information


Lincolnshire Primary Care Trust (UK)

Sponsor details

c/o Mrs Lynne Moody
Head of Professional Standards
Teaching PCT and Research (Deputy Director)
Cross O'Cliff Court
Bracebridge Heath
United Kingdom
+44 (0)1522 513355

Sponsor type




Funder type


Funder name

The Health Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 protocol in:
2014 treatment fidelity results in:

Publication citations

  1. Protocol

    Siriwardena AN, Apekey T, Tilling M, Harrison A, Dyas JV, Middleton HC, Ørner R, Sach T, Dewey M, Qureshi ZM, Effectiveness and cost-effectiveness of an educational intervention for practice teams to deliver problem focused therapy for insomnia: rationale and design of a pilot cluster randomised trial., BMC Fam Pract, 2009, 10, 9, doi: 10.1186/1471-2296-10-9.

  2. Treatment fidelity results

    Dyas JV, Togher F, Siriwardena AN, Intervention fidelity in primary care complex intervention trials: qualitative study using telephone interviews of patients and practitioners., Qual Prim Care, 2014, 22, 1, 25-34.

Additional files

Editorial Notes