Cognitive self-therapy (CST) for patients with chronic-recurrent depression or anxiety

ISRCTN	ISRCTN61381864
DOI	https://doi.org/10.1186/ISRCTN61381864
Protocol serial number	NTR375; OG 00-028
Sponsor	University Medical Centre Groningen (UMCG) (Netherlands)
Funders	, Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), Development, University Medical Centre Groningen (UMCG) (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof D. Wiersma
Scientific

University Medical Center Groningen
Department of Psychiatry
Hanzeplein 1
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 3613839
Email	d.wiersma@med.umcg.nl

Primary study design	Interventional
Study design	Multicentre randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	CST
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	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 patients 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
Primary outcome measure(s)	Symptoms of anxiety and depression (SCL-90; BDI; ZBV)
Key secondary outcome measure(s)	1. Quality of life 2. Social functioning 3. WHO Qol 4. Euroqol
Completion date	01/12/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	151
Key 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
Key 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
Date of first enrolment	01/03/2000
Date of final enrolment	01/12/2004

University Medical Center Groningen

Groningen
9700 RB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2007		Yes	No
Results article	results	01/01/2008		Yes	No