Condition category
Nervous System Diseases
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
18/09/2008
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 Annemieke van Straten

ORCID ID

Contact details

Vrije Universiteit Amsterdam
FPP Dept. Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
+31 (0)20 5988970
a.van.straten@psy.vu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NFGV 5978 (national fund public mental health); NTR62

Study information

Scientific title

A randomised trial of a behavioural training programme through television for patients with insomnia

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Insomnia

Intervention

A behavioural training programme for insomnia will be broadcasted by Teleac this fall. This trial will take place before the start of the broadcasting with three groups:
1. Each week a DVD is sent to the patient's home for 6 weeks. Each DVD contains part of the behavioural training programme (25 minutes each) + book that belongs to the this television programme.
2. Same as the first condition without the book
3. Waiting list control group. These patients may watch the regular television programme later on when broadcasted by Teleac.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Sleep efficiency post-treatment (6 weeks) and 3 months later .

Secondary outcome measures

1. Quality of sleep
2. Cognitions about sleep
3. Use of sleep medication
4. Symptoms of depression and anxiety
5. Quality of life
6. Absence of work
7. Health care use

All measured post-treatment (6 weeks) and 3 months later.

Overall trial start date

01/08/2005

Overall trial end date

01/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

A sleep problem defined as lying awake for at least 30 minutes for at least 3 nights a week for at least 1 month.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

300

Participant exclusion criteria

A high score on the screener for depression (Center for Epidemiologic Studies-Depression [CESD]) or anxiety (Hospital Anxiety and Depression Scale [HADS]).

Recruitment start date

01/08/2005

Recruitment end date

01/08/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrije Universiteit Amsterdam
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

FPP Dept. Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
+31 (0)20 598 8970
a.van.straten@psy.vu.nl

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl

Funders

Funder type

Government

Funder name

The National Fund for Public Mental Health (Nationaal-Fonds-Geestelijke-Volksgezondheid [NFGV]) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Vrije University Medical Centre (VUMC) (The Netherlands) - Department of Clinical Psychology

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