Treatment for insomnia in Improving Access to Psychological Therapies (IAPT) services
| ISRCTN | ISRCTN17064995 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17064995 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/06/2011
- Registration date
- 28/07/2011
- Last edited
- 29/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Scientific
East Wing
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
United Kingdom
| Phone | +44 (0)20 3317 3109 |
|---|---|
| j.cape@ucl.ac.uk |
Study information
| Study design | Pragmatic two-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| 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(s) | London - City Road & Hampstead REC approved on 27th July 2011 (Ref No:11/LO/0989) |
| 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 |
| Primary outcome measure | 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 study start date | 01/09/2011 |
| Overall study end date | 01/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 240 |
| 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 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
- England
- United Kingdom
Study participating centre
NW1 0PE
United Kingdom
Sponsor information
Hospital/treatment centre
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
England
United Kingdom
"ROR" |
https://ror.org/03ekq2173 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2016 | Yes | No |
Editorial Notes
29/01/2018: Publication reference added.
