Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0321179916
Study information
Scientific title
Cognitive behavioural therapy for persistent insomnia - a randomised controlled trial
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Mental and Behavioural Disorders: Insomnia
Intervention
1. Treatment group
2. Deferred treatment group
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/10/2004
Overall trial end date
01/08/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients referred by their GP, aged between 18 and 65 and needed to meet the APA criteria for insomnia
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Total sample size target is 70 (35 per comparison group).
Participant 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
Recruitment start date
01/10/2004
Recruitment end date
01/08/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Ann's Hospital
Poole
BH13 7LN
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Dorset HealthCare 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