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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01484223 |
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Date of registration:
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30/11/2011 |
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Primary sponsor: |
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Public title:
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Effectiveness of Cognitive Behavioral Intervention in Patients With Symptoms Somatization in Primary Care
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Scientific title:
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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 |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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242 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01484223 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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Spain
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Contacts
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Name:
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Alberto López García-Franco, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gerencia Atención Primaria. Madrid |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Quality of Life
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Intervention(s)
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Behavioral: Cognitive Behavioral Therapy
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Primary Outcome(s)
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Perceived quality of life
[Time Frame: Change from baseline in quality of life at 12 months after the intervention]
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Secondary Outcome(s)
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Number of examinations
[Time Frame: Number of examinations from baseline until 12 months after the intervention]
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Prescribed medicine
[Time Frame: Prescribed medicine from baseline until 12 months after the intervention]
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Questionnarie on Global Clinical Impression
[Time Frame: Change from baseline in patient and doctor´s perception at 12 months afer the intervention]
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Temporary labor disability (TLD)
[Time Frame: Days on TLD from baseline until 12 months after the intervention]
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Secondary ID(s)
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FIS PI08/90707
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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