Cognitive behavioural therapy for persistent insomnia - a randomised controlled trial
| ISRCTN | ISRCTN27620037 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27620037 |
| Secondary identifying numbers | N0321179916 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 01/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Stuart Purcell
Scientific
Scientific
St Ann's Hospital
69 Haven Road
Canford Cliffs
Poole
BH13 7LN
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | Cognitive behavioural therapy for persistent insomnia - a randomised controlled trial |
| Study objectives | To evaluate the clinical effectiveness of a manualised multifaceted CBT intervention administered on an individual basis to patients with persistent insomnia who present with their insomnia. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Insomnia |
| Intervention | 1. Treatment group 2. Deferred treatment group |
| Intervention type | Other |
| Primary outcome measure | 1. Sleep onset 2. Total sleep time 3. Wake time after sleep onset 4. Pittsburgh Sleep Quality Index 5. Disability days and service use |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2004 |
| Completion date | 01/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | Total sample size target is 70 (35 per comparison group). |
| Key inclusion criteria | Patients referred by their GP, aged between 18 and 65 and needed to meet the APA criteria for insomnia |
| Key exclusion criteria | 1. Psychosis 2. Significant cognitive impairment 3. Affective disorders of moderate to severe severity as diagnosed by ICD10 4. Insomnia secondary to medical illness requiring specific treatments |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 01/08/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Ann's Hospital
Poole
BH13 7LN
United Kingdom
BH13 7LN
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Dorset HealthCare NHS Foundation Trust (UK)
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 |
