Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
01/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stuart Purcell

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes