The Teleac course for insomnia: a randomised controlled trial (RCT)

ISRCTN	ISRCTN37858178
DOI	https://doi.org/10.1186/ISRCTN37858178
Secondary identifying numbers	NFGV 5978 (national fund public mental health); NTR62

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Annemieke van Straten
Scientific

Vrije Universiteit Amsterdam
FPP Dept. Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 5988970
Email	a.van.straten@psy.vu.nl

Study design	Randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	A randomised trial of a behavioural training programme through television for patients with insomnia
Study objectives	Not provided at time of registration
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/08/2005
Completion date	01/08/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	300
Total final enrolment	247
Key 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.
Key exclusion criteria	A high score on the screener for depression (Center for Epidemiologic Studies-Depression [CESD]) or anxiety (Hospital Anxiety and Depression Scale [HADS]).
Date of first enrolment	01/08/2005
Date of final enrolment	01/08/2006

Vrije Universiteit Amsterdam

Amsterdam
1081 BT
Netherlands

Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre

FPP Dept. Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands

Government

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

No information available

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2009	28/06/2019	Yes	No

28/06/2019: Publication reference and total final enrolment.