Cognitive Behaviour Therapy for Abridged Somatization Disorder (Somatic Symptom Index [SSI] 4,6) patients in primary care

ISRCTN	ISRCTN69944771
DOI	https://doi.org/10.1186/ISRCTN69944771
Protocol serial number	04/1993
Sponsor	Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Funder	Carlos III Institute of Health (Madrid), Funding for Health Research for Social Security (Instituto de Salud Carlos III, Fondo de Investigaciones Sanitarias de la Seguridad Social) (Spain)

Submission date: 23/12/2007
Registration date: 14/02/2008
Last edited: 17/03/2014

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

Dr Javier Garcia Campayo
Scientific

Hospital Miguel Servet
Avda Isabel la Catolica 1-3
Zaragoza
50.009
Spain

Phone	+34 976 253621; +34 686 673302
Email	jgarcamp@arrakis.es

Study information

Primary study design	Interventional
Study design	Multi-centre randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	CBTASD
Study objectives	Patients randomized to cognitive behavioural therapy significantly improve in measures related to quality of life, somatic symptoms, psychopathology and health services use.
Ethics approval(s)	Aragon Ethics Review Board, approved in June 2005 (ref: 05/24)
Health condition(s) or problem(s) studied	Abridged somatization disorder
Intervention	The participants will be randomely allocated to the intervention and control groups in equal numbers. Intervention group: A manualised intervention program of cognitive behaviour therapy (10 sessions) for somatoform disorders according to Escobar (Arch Intern Med 2006; 166: 1512-18; http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16864762) Control group: Usual care plus "Smith's norms." The general practitioners receive a short letter on recommendations (widely accepted and obtained from evidence-based medicine) to manage patients with somatoform disorders. Duration of interventions: 3 months
Intervention type	Other
Primary outcome measure(s)	Severity of Clinical Global Impression scale at baseline, 3 and 6 months and 1-year follow-up
Key secondary outcome measure(s)	The following will be assessed at baseline, 3 and 6 months and 1-year follow-up: 1. Quality of life: 36-item Short Form health survey (SF-36) 2. Hamilton Depression Scale 3. Hamilton Anxiety Scale 4. Screening for Somatoform Symptoms [SOMS]
Completion date	01/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	140
Key inclusion criteria	1. Age 18-65 years 2. Fluent in Spanish language 3. Diagnosis of Abridged Somatization Disorder (SSI 4,6) according to Escobar's criteria 4. Stable pharmacological treatment during last month and the expectation to maintain it during the next three months
Key exclusion criteria	1. Primary diagnosis of a psychiatric disorder different from somatization disorder 2. Severe personality disorder that interferes with adequate completion of the intervention program 3. Impossible to attend the intervention therapy 4. Refusal to participate
Date of first enrolment	15/01/2008
Date of final enrolment	01/07/2009

Locations

Countries of recruitment

Spain

Study participating centre

Hospital Miguel Servet

Zaragoza
50.009
Spain

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	01/07/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes