Effectiveness of Cognitive Behavioral Intervention in Patients With Symptoms Somatization in Primary Care
- Conditions
- Quality of Life
- Interventions
- Behavioral: Cognitive Behavioral Therapy
- Registration Number
- NCT01484223
- Lead Sponsor
- Gerencia de Atención Primaria, Madrid
- Brief Summary
The purpose of this study is to evaluate the efectiveness of a behavioral cognitive grupal intervention (BCI) in patients with somatization symptoms which has an effect on the perceived quality of life front conventional intervention.
- Detailed Description
Aim: to determine whether a cognitive-behavioral group intervention in patients with unexplicated somatic symptoms, that have come to the primary care medical in Madrid, is more effective than normal practice in terms of improving life quality at one year.
Method:
Design:cluster randomized trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service. unit of randomization are centres.Analysis unit: patients between 18 and 65 years old.
Intervention: The cognitive behavioral grupal Terapy in the internention group and the usual intervention in the control group.
Sample size adjusted for design effect=242 (121 in each arm). Main response variable: preceived quality of life (SF-12).
Data Analysis:comparison of the proportion of patients that improve in 4 or more points in the area of Mental Healthcare from the SF-12 in both groups,at 6 months and 1 year after patient inclusion.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
- Attending patients with 2 or more medically unexplained somatic symptoms during the last 6 months.
- Having came to medical examination on primary care at least 10 times during the last year.
- be able to follow the trial´s demands, not have plans for moving another place and understand the Spanish language.
- Patients who consent to take part.
- Diagnostics on serious mental disorder.
- Suicidal intentions at the moment of getting involved in the study.
- Diagnostics on addiction to toxic substances.
- Diagnostics on well-known body illness responsible for the symptoms.
- Previous psychotherapy during the previous year.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group Cognitive Behavioral Therapy Intervention group: Structured nursing intervention
- Primary Outcome Measures
Name Time Method Perceived quality of life Change from baseline in quality of life at 12 months after the intervention Perceived quality of life: Quality of life measured by SF-12 questionnare on Mental Healthcare Change from baseline in quality of life at 3, 6 and 12 months after the intervention.
- Secondary Outcome Measures
Name Time Method Number of examinations Number of examinations from baseline until 12 months after the intervention Number of requested and programmed doctor´s examinations during the period of study (itemized between infirmary and medicine)
Temporary labor disability (TLD) Days on TLD from baseline until 12 months after the intervention Questionnarie on Global Clinical Impression Change from baseline in patient and doctor´s perception at 12 months afer the intervention It is used to assess the patient´s(PGI questionnarie) and the doctor´s(CGI questionnarie)perception on the former´s improvement after the interventions have been carried out. It will be undertaken 6 and 12 moths later, so as to assess the effectiveness of the group intervention.
Prescribed medicine Prescribed medicine from baseline until 12 months after the intervention Prescribed medicine during the period of study, with doubtful therapeutic value for their processing, related to the unexplained somatic symptoms. The included medicines are those related to the functional symptomatology
Trial Locations
- Locations (1)
Gerencia Atención Primaria, Madrid.
🇪🇸Madrid, Spain