Condition category
Mental and Behavioural Disorders
Date applied
04/04/2008
Date assigned
11/07/2008
Last edited
21/03/2016
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

Prof Mark van der Gaag

ORCID ID

Contact details

Oude Haagweg 357
Den Haag
2552 ES
Netherlands
+31 (0)70 391 7622
mark@van-der-gaag.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMW 120510001; NTR1085

Study information

Scientific title

Prevention of psychosis with a cognitive behavioural intervention in help-seeking young people with an at risk mental state for developing psychosis

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

Centrale Commissie Mensgebonden Onderzoek (CCMO) Central Committee for Research Involving Human Subjects, 29/08/2007, CCMO nr NL17123.097.07

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/12/2007

Overall trial end date

01/12/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

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

Trial participating centre

Oude Haagweg 357
Den Haag
2552 ES
Netherlands

Sponsor information

Organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Sponsor details

Laan van Nieuw Oost Indië 334
P.O. Box 93245
Den Haag
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl

Sponsor type

Research organisation

Website

http://www.zonmw.nl

Funders

Funder type

Research organisation

Funder name

ZonMw (ref: ZonMW 120510001)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

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

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20307268
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22941746
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26994397

Publication citations

  1. Protocol

    Rietdijk J, Dragt S, Klaassen R, Ising H, Nieman D, Wunderink L, Delespaul P, Cuijpers P, Linszen D, van der Gaag M, A single blind randomized controlled trial of cognitive behavioural therapy in a help-seeking population with an At Risk Mental State for psychosis: the Dutch Early Detection and Intervention Evaluation (EDIE-NL) trial., Trials, 2010, 11, 30, doi: 10.1186/1745-6215-11-30.

  2. Results

    van der Gaag M, Nieman DH, Rietdijk J, Dragt S, Ising HK, Klaassen RM, Koeter M, Cuijpers P, Wunderink L, Linszen DH, Cognitive behavioral therapy for subjects at ultrahigh risk for developing psychosis: a randomized controlled clinical trial., Schizophr Bull, 2012, 38, 6, 1180-1188, doi: 10.1093/schbul/sbs105.

  3. Results

    Ising HK, Kraan TC, Rietdijk J, Dragt S, Klaassen RM, Boonstra N, Nieman DH, Willebrands-Mendrik M, van den Berg DP, Linszen DH, Wunderink L, Veling W7, Smit F, van der Gaag M, Four-Year Follow-up of Cognitive Behavioral Therapy in Persons at Ultra-High Risk for Developing Psychosis: The Dutch Early Detection Intervention Evaluation (EDIE-NL) Trial, 2016.

Additional files

Editorial Notes

21/03/2016: Publication reference added.