Condition category
Mental and Behavioural Disorders
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
01/09/2009
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

Prof Nigel Mathers

ORCID ID

Contact details

Institute of General Practice and Primary Care
University of Sheffield
Community Sciences Centre
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 (0)114 271 5922
n.mathers@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 95/30/02

Study information

Scientific title

Acronym

Study hypothesis

In a randomised controlled trial the proposed study would evaluate the costs and consequences of using a structured "package" of psychological treatments for insomnia to promote and maintain low frequency, intermittent hypnotic drug consumption among those unwilling to discontinue their medication.

Ethics approval

Not provided at time of registration.

Study design

Pragmatic cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and behavioural disorders: Other mental disorder

Intervention

Structured package vs standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Main outcomes included: global sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI); frequency of life (as measured by the SF-36); NHS service costs; and overall cost utility. For statistical analysis all non-categorical outcomes were modelled as baseline minus follow-up change scores

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/1998

Overall trial end date

31/07/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 31-92 with chronic sleep problems who had been receiving repeat prescriptions for hypnotic drugs for at least one month

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

209

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/08/1998

Recruitment end date

31/07/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of General Practice and Primary Care
Sheffield
S5 7AU
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14960215
2004 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/14960254

Publication citations

  1. Results

    Morgan K, Dixon S, Mathers N, Thompson J, Tomeny M, Psychological treatment for insomnia in the management of long-term hypnotic drug use: a pragmatic randomised controlled trial., Br J Gen Pract, 2003, 53, 497, 923-928.

  2. HTA monograph

    Morgan K, Dixon S, Mathers N, Thompson J, Tomeny M, Psychological treatment for insomnia in the regulation of long-term hypnotic drug use., Health Technol Assess, 2004, 8, 8, iii-iv, 1-68.

Additional files

Editorial Notes