Condition category
Mental and Behavioural Disorders
Date applied
12/06/2011
Date assigned
28/07/2011
Last edited
24/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Sleep is an essential requirement for life, and is vital for people to be able to function. Insomnia is a common sleep disorder, where the sufferer finds it difficult to get to sleep and/or sty asleep. It can cause great distress, affecting mood, concentration and quality of life. While sleeping pills offer a short term solution, they cannot be used in the long term as they are highly addictive and eventually lose their effectiveness. The recommended treatment for insomnia is a form of therapy called cognitive behavioural therapy for insomnia (CBT-I). This involves teaching the sufferer ways to recognise and change the thoughts and beliefs that are preventing them from sleeping, such as “racing thoughts”. This therapy is not always available to people suffering from insomnia, as it is a specialised technique which requires extensive training. Many people with insomnia do not have access to this type of therapy and so use the Improving Access to Psychological Therapies (IAPT) services in the UK. IAPT services are designed to provide help to people suffering from anxiety or depression. The usual treatment given by IPAT for insomnia is giving advice and written information about how to improve sleep practices. The aim of this study is to compare the effectiveness of CBT-I and IAPT services for treating insomnia.

Who can participate?
Adults who report difficulty getting to sleep and/or staying asleep for at least three months.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in the first group attend weekly sessions of CBT-I for a total of five weeks. Those in the second group receive the standard advice and treatment for insomnia that is routinely provided by IPAT services. Before treatment, after treatment and then at a 20 week follow up, participants complete questionnaires about their sleeping habits and general mental health.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
St Pancras Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2011 to September 2013

Who is funding the study?
Camden and Islington NHS Foundation Trust (UK)

Who is the main contact?
1. Professor John Cape
j.cape@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Cape

ORCID ID

Contact details

East Wing
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
United Kingdom
+44 (0)20 3317 3109
j.cape@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of cognitive behavioural therapy (CBT) groups for insomnia delivered by IAPT low intensity workers compared to treatment as usual: a randomised controlled pragmatic trial

Acronym

Study hypothesis

What is the effectiveness of cognitive behaviour therapy for insomnia (CBT-I) groups compared to treatment as usual in treating insomnia in routine Improving Access to Psychological Therapies (IAPT) Services?

Ethics approval

London - City Road & Hampstead REC approved on 27th July 2011 (Ref No:11/LO/0989)

Study design

Pragmatic two-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Insomnia

Intervention

1. Patients randomised to group CBT-I will attend 5 weekly 90 minute sessions in a class of up to 16 participants. The group CBT-I intervention will follow a manualised treatment protocol used in three previous treatment trials and will include education about sleep and common CBT-I components such as stimulus control, sleep restriction, and cognitive therapy strategies delivered by the IAPT low intensity workers.
2. Patients randomised to treatment as usual will receive advice and treatment for insomnia routinely provided within primary care and IAPT services

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Sleep efficiency at end of treatment. This is calculated as the percentage time in bed that is reported by the patient as spent asleep.

Secondary outcome measures

1. Sleep efficiency at 20 week follow-up. This is calculated as the percentage time in bed that is reported by the patient as spent asleep.
2. Total Sleep Condition Indicator (SCI) score, and response and remission on the SCI post-treatment
3. Patient Health Questionnaire Depression Scale (PHQ-9) scores at post-treatment and follow-up
4. Patient Health Questionnaire Generalised Anxiety Disorder Scale (GAD-7) scores at post-treatment and follow-up
5. Work and Social Adjustment Scale (WASAS) at post-treatment and follow up
6. Satisfaction post-treatment with the treatment and service received for insomnia

Overall trial start date

01/09/2011

Overall trial end date

01/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Self-reported concern about difficulty getting to sleep and/or staying asleep of at least 3 months duration
2. Age 18 or over
3. Good enough understanding and use of English to be able to benefit from a psychoeducational group delivered in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Untreated major physical or mental illness, including untreated major depressive disorder or an anxiety disorder (patients with major illness may be included if they are being treated)
2. Untreated substance misuse
3. Excessive daytime sleepiness suggestive of sleep apnoea, narcolepsy or other specific sleep disorder
4. Contraindication to treatment in a group

Recruitment start date

01/09/2011

Recruitment end date

01/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

East Wing
London
NW1 0PE
United Kingdom

Sponsor information

Organisation

Camden and Islington NHS Foundation Trust (UK)

Sponsor details

St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Camden and Islington NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes