Quality of Life
Conditions
Keywords
Primary Health Care, Somatization symptoms, Cognitive Behavioral Therapy, Nursing intervention
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy
Four Cognitive behavioral group sessions. Each session will last two hours a week
Sponsors
Instituto de Salud Carlos III
Fondo de Investigacion Sanitaria
Gerencia de Atención Primaria, Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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 |
| Temporary labor disability (TLD) | Days on TLD from baseline until 12 months after the intervention | — |
Countries
Spain
Outcome results
None listed