The prevention of psychosis in at risk mental state

ISRCTN	ISRCTN21353122
DOI	https://doi.org/10.1186/ISRCTN21353122
Protocol serial number	ZonMW 120510001; NTR1085
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Funder	ZonMw (ref: ZonMW 120510001)

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 of protocol

Not provided at time of registration

Contact information

Prof Mark van der Gaag
Scientific

Oude Haagweg 357
Den Haag
2552 ES
Netherlands

Phone	+31 (0)70 391 7622
Email	mark@van-der-gaag.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	240
Key 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
Key exclusion criteria	1. Current or previous receipt of antipsychotic medication 2. Moderate to severe learning disability 3. Organic impairment 4. Non-Dutch speaking
Date of first enrolment	01/12/2007
Date of final enrolment	01/12/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

Oude Haagweg 357

Den Haag
2552 ES
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	01/11/2012		Yes	No
Results article	results	01/09/2016		Yes	No
Protocol article	protocol	22/03/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/03/2016: Publication reference added.