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Completed

NCT Number: NCT01484223

Effectiveness of Cognitive Behavioral Intervention in Patients With Symptoms Somatization in Primary Care

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.

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Key information

Conditions

Quality of Life

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gerencia Atención Primaria, Madrid.

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Four Cognitive behavioral group sessions. Each session will last two hours a week

Other names: Primary Health Care, Somatization symptoms, Nursing intervention, Quality of life

Primary outcomes

  1. 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

  1. Questionnarie on Global Clinical Impression

    Time frame: 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.

  2. Number of examinations

    Time frame: 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)

  3. Prescribed medicine

    Time frame: 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

  4. Temporary labor disability (TLD)

    Time frame: Days on TLD from baseline until 12 months after the intervention

Sponsors and collaborators

Lead sponsor

Gerencia de Atención Primaria, Madrid

Other Gov

Collaborators

  • Fondo de Investigacion Sanitaria
  • Instituto de Salud Carlos III

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2011
Registry last updated
Oct 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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