Effectiveness of Cognitive Behavioral Intervention in Patients With Symptoms Somatization in Primary Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||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|
- Perceived quality of life [ Time Frame: Change from baseline in quality of life at 12 months after the intervention ] [ Designated as safety issue: No ]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.
- Questionnarie on Global Clinical Impression [ Time Frame: Change from baseline in patient and doctor´s perception at 12 months afer the intervention ] [ Designated as safety issue: No ]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 [ Time Frame: Number of examinations from baseline until 12 months after the intervention ] [ Designated as safety issue: No ]Number of requested and programmed doctor´s examinations during the period of study (itemized between infirmary and medicine)
- Prescribed medicine [ Time Frame: Prescribed medicine from baseline until 12 months after the intervention ] [ Designated as safety issue: No ]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) [ Time Frame: Days on TLD from baseline until 12 months after the intervention ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||August 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Experimental Group
Intervention group: Structured nursing intervention
Behavioral: Cognitive Behavioral Therapy
Four Cognitive behavioral group sessions. Each session will last two hours a week
No Intervention: No intervention
Control group: conventional intervention or non_support
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484223
|Gerencia Atención Primaria, Madrid.|
|Principal Investigator:||Alberto López García-Franco, MD||Gerencia Atención Primaria. Madrid|