Efectiveness of a Cognitive Behavioral Intervention in Patients With Symptoms Somatization, as Measure Quality of Life, Front the Clinical Practice Usual Action in Primary Health Care. A Controlled Clinical Trial With Parallel Groups
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Quality of Life
- Sponsor
- Gerencia de Atención Primaria, Madrid
- Enrollment
- 242
- Locations
- 1
- Primary Endpoint
- Perceived quality of life
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Esperanza Escortell
Epidemiologist
Gerencia de Atención Primaria, Madrid
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Perceived quality of life
Time Frame: 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 Outcomes
- Number of examinations(Number of examinations from baseline until 12 months after the intervention)
- 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)
- Prescribed medicine(Prescribed medicine from baseline until 12 months after the intervention)