Cognitive behavioural therapy for persistent insomnia - a randomised controlled trial

ISRCTN	ISRCTN27620037
DOI	https://doi.org/10.1186/ISRCTN27620037
Protocol serial number	N0321179916
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	Dorset HealthCare NHS Foundation Trust (UK)

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

Dr Stuart Purcell
Scientific

St Ann's Hospital
69 Haven Road
Canford Cliffs
Poole
BH13 7LN
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	1. Sleep onset 2. Total sleep time 3. Wake time after sleep onset 4. Pittsburgh Sleep Quality Index 5. Disability days and service use
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/08/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	70
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

St Ann's Hospital

Poole
BH13 7LN
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes