The prevention of psychosis in at risk mental state
| ISRCTN | ISRCTN21353122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21353122 |
| Secondary identifying numbers | ZonMW 120510001; NTR1085 |
- Submission date
- 04/04/2008
- Registration date
- 11/07/2008
- Last edited
- 21/03/2016
- 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
Not provided at time of registration
Contact information
Prof Mark van der Gaag
Scientific
Scientific
Oude Haagweg 357
Den Haag
2552 ES
Netherlands
| Phone | +31 (0)70 391 7622 |
|---|---|
| mark@van-der-gaag.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prevention of psychosis with a cognitive behavioural intervention in help-seeking young people with an at risk mental state for developing psychosis |
| Study acronym | EDIE.NL (Early Detection Intervention Evaluation Netherlands) |
| Study hypothesis | A cognitive behavioural therapy (CBT) intervention will reduce the transition rate into psychosis. |
| Ethics approval(s) | Centrale Commissie Mensgebonden Onderzoek (CCMO) Central Committee for Research Involving Human Subjects, 29/08/2007, CCMO nr NL17123.097.07 |
| Condition | Psychosis |
| Intervention | In both arms treatment as usual will be provided for the complaints that made the person seek help. In the experimental arm there will be a 25-session (over six months) add-on with a CBT therapist aimed at normalising psychotic-like experiences, becoming aware of and changing risky thinking styles such as jumping to conclusions, confirmatory bias, selective attention, covariation bias, emotional reasoning, etc. Treatment duration is six months, patients will be followed-up for 18 months. |
| Intervention type | Other |
| Primary outcome measure | Rate of transitions into psychosis, diagnoses will be made using Schedules for Clinical Assessment in Neuropsychiatry (SCAN) 2.1 interview. Measurement moments for primary and secondary measures are at 0, 6, 12, and 18 months. A check on the increase or decrease of psychotic-like experiences are additionally assessed in a short session at months 2, 4, 9, and 15. |
| Secondary outcome measures | 1. Depression (Beck Depression Inventory [BDI]) 2. Social anxiety (Social Interaction Anxiety Scale [SIAS]) 3. European quality of life (EQ5D) health questionnaire Measurement moments for primary and secondary measures are at 0, 6, 12, and 18 months. |
| Overall study start date | 01/12/2007 |
| Overall study end date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 240 |
| Participant inclusion criteria | 1. Aged 14 to 35 years, either sex 2. Fullfilling At Risk Mental State criteria of the Comprehensive Assessment of At Risk Mental State, criteria of July 2007 |
| Participant exclusion criteria | 1. Current or previous receipt of antipsychotic medication 2. Moderate to severe learning disability 3. Organic impairment 4. Non-Dutch speaking |
| Recruitment start date | 01/12/2007 |
| Recruitment end date | 01/12/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Oude Haagweg 357
Den Haag
2552 ES
Netherlands
2552 ES
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost Indië 334
P.O. Box 93245
Den Haag
2509 AE
Netherlands
| Phone | +31 (0)70 349 5111 |
|---|---|
| info@zonmw.nl | |
| Website | http://www.zonmw.nl |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
ZonMw (ref: ZonMW 120510001)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/03/2010 | Yes | No | |
| Results article | results | 01/11/2012 | Yes | No | |
| Results article | results | 01/09/2016 | Yes | No |
Editorial Notes
21/03/2016: Publication reference added.
