Condition category
Mental and Behavioural Disorders
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
17/08/2009
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 D. Wiersma

ORCID ID

Contact details

University Medical Center Groningen
Department of Psychiatry
Hanzeplein 1
Groningen
9700 RB
Netherlands
+31 (0)50 3613839
d.wiersma@med.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR375; OG 00-028

Study information

Scientific title

Acronym

CST

Study hypothesis

Does cognitive self-therapy (CST) in outpatient mental health care have any superiority as to cost-effectiveness and outcome compared to treatment as usual?

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Depression, anxiety disorders

Intervention

Treatment as usual (TAU) versus CST which is a structured method that seeks to restructure cognitive schemata by focusing on problems in social functioning and relationships and consists of a Preparatory Phase, an Orientation Course of three weekly morning-meetings to practice with peers; a Basic Course (BC) of 5 weekly, day-long sessions in which patients learn to manage self-therapy sessions with peers.
Those who perform these sessions adequately are certified to participate in weekly meetings, now led by peers in accordance with the manual, as taught during the BC.
The patientsÂ’ role in the treatment gradually evolves into that of 'paraprofessionals', such that finally they conduct Self-Therapy sessions in reciprocal relationships with peers.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Symptoms of anxiety and depression (SCL-90; BDI; ZBV)

Secondary outcome measures

1. Quality of life
2. Social functioning
3. WHO Qol
4. Euroqol

Overall trial start date

01/03/2000

Overall trial end date

01/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. DSM IV diagnosis of chronic and/or recurrent depression, dysthemic disorder or (generalised) anxiety disorder
2. Duration of symptoms more than 2 years
3. 18-65 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

151

Participant exclusion criteria

1. Suicidal behaviour
2. Psychosis
3. Substance dependency
4. IQ <85
5. Lack of insight in personal vulnerability in social contacts or relationship

Recruitment start date

01/03/2000

Recruitment end date

01/12/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen (UMCG) (Netherlands)

Sponsor details

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl/azg/nl/english/azg/

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Development, University Medical Centre Groningen (UMCG) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17076917
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18005369

Publication citations

  1. Results

    den Boer PC, Wiersma D, Ten Vaarwerk I, Span MM, Stant AD, Van den Bosch RJ, Cognitive self-therapy for chronic depression and anxiety: a multi-centre randomized controlled study., Psychol Med, 2007, 37, 3, 329-339, doi: 10.1017/S0033291706009214.

  2. Results

    Stant AD, Ten Vergert EM, den Boer PC, Wiersma D, Cost-effectiveness of cognitive self-therapy in patients with depression and anxiety disorders., Acta Psychiatr Scand, 2008, 117, 1, 57-66, doi: 10.1111/j.1600-0447.2007.01122.x.

Additional files

Editorial Notes