Psychological treatment in the regulation of long-term hypnotic drug use
| ISRCTN | ISRCTN33231235 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33231235 |
| Protocol serial number | HTA 95/30/02 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 01/09/2009
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Nigel Mathers
Scientific
Scientific
Institute of General Practice and Primary Care
University of Sheffield
Community Sciences Centre
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
| Phone | +44 (0)114 271 5922 |
|---|---|
| n.mathers@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pragmatic cluster randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Mental and behavioural disorders: Other mental disorder |
| Intervention | Structured package vs standard care |
| Intervention type | Other |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 209 |
| Key inclusion criteria | Patients aged 31-92 with chronic sleep problems who had been receiving repeat prescriptions for hypnotic drugs for at least one month |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/08/1998 |
| Date of final enrolment | 31/07/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute of General Practice and Primary Care
Sheffield
S5 7AU
United Kingdom
S5 7AU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2003 | Yes | No | |
| Other publications | HTA monograph | 01/02/2004 | Yes | No |
