Condition category
Mental and Behavioural Disorders
Date applied
23/12/2007
Date assigned
14/02/2008
Last edited
17/03/2014
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

Dr Javier Garcia Campayo

ORCID ID

Contact details

Hospital Miguel Servet
Avda Isabel la Catolica 1-3
Zaragoza
50.009
Spain
+34 976 253621; +34 686 673302
jgarcamp@arrakis.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04/1993

Study information

Scientific title

Acronym

CBTASD

Study hypothesis

Patients randomized to cognitive behavioural therapy significantly improve in measures related to quality of life, somatic symptoms, psychopathology and health services use.

Ethics approval

Aragon Ethics Review Board, approved in June 2005 (ref: 05/24)

Study design

Multi-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Severity of Clinical Global Impression scale at baseline, 3 and 6 months and 1-year follow-up

Secondary outcome measures

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]

Overall trial start date

15/01/2008

Overall trial end date

01/07/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140 patients

Participant 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

Recruitment start date

15/01/2008

Recruitment end date

01/07/2009

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Miguel Servet
Zaragoza
50.009
Spain

Sponsor information

Organisation

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)

Sponsor details

Ctra. Majadahonda - Pozuelo
Km 2 28220 - Majadahonda
Madrid
28220
Spain
+34 91 5097900
director.cnsa@isciii.es

Sponsor type

Hospital/treatment centre

Website

http://www.isciii.es

Funders

Funder type

Government

Funder name

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)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23788694

Publication citations

  1. Results

    Moreno S, Gili M, Magallón R, Bauzá N, Roca M, Del Hoyo YL, Garcia-Campayo J, Effectiveness of group versus individual cognitive-behavioral therapy in patients with abridged somatization disorder: a randomized controlled trial., Psychosom Med, 75, 6, 600-608, doi: 10.1097/PSY.0b013e31829a8904.

Additional files

Editorial Notes