The Teleac course for insomnia: a randomised controlled trial (RCT)
| ISRCTN | ISRCTN37858178 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37858178 |
| Protocol serial number | NFGV 5978 (national fund public mental health); NTR62 |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Funders | The National Fund for Public Mental Health (Nationaal-Fonds-Geestelijke-Volksgezondheid [NFGV]) (The Netherlands), Vrije University Medical Centre (VUMC) (The Netherlands) - Department of Clinical Psychology |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 28/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Annemieke van Straten
Scientific
Scientific
Vrije Universiteit Amsterdam
FPP Dept. Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 5988970 |
|---|---|
| a.van.straten@psy.vu.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Sleep efficiency post-treatment (6 weeks) and 3 months later . |
| Key secondary outcome measure(s) |
1. Quality of sleep |
| Completion date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vrije Universiteit Amsterdam
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
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 | 01/01/2009 | 28/06/2019 | Yes | No |
Editorial Notes
28/06/2019: Publication reference and total final enrolment.
