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 |
| Secondary identifying numbers | 04/1993 |
- 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
Scientific
Hospital Miguel Servet
Avda Isabel la Catolica 1-3
Zaragoza
50.009
Spain
| Phone | +34 976 253621; +34 686 673302 |
|---|---|
| jgarcamp@arrakis.es |
Study information
| Study design | Multi-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 15/01/2008 |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 140 patients |
| 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
50.009
Spain
Sponsor information
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Hospital/treatment centre
Hospital/treatment centre
Ctra. Majadahonda - Pozuelo
Km 2 28220 - Majadahonda
Madrid
28220
Spain
| Phone | +34 91 5097900 |
|---|---|
| director.cnsa@isciii.es | |
| Website | http://www.isciii.es |
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Government
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
