A pilot study to treat anxiety, depression and somatizations in Spanish Primary Care Services with psychological techniques in seven group sessions: Comparison of results using psychological treatment versus usual Primary Care treatment, with follow-up assessments after 3, 6 and 12 months.
- Conditions
- Emotional disorders specified as anxiety disorders (e.g., panic disorder, generalized anxiety disorder, social phobia, specific phobia), mood disorders (e.g., major depressive disorder, dysthymia), somatizations (e.g., somatization disorder, pain disorder)Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2013-001955-11-ES
- Lead Sponsor
- Psicofundación. Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicología
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1126
Any adult patient seeking Primary Care treatment at any of the selected sites, regardless of his/her age and sex, with a probable anxiety, mood and/or somatisation disorder (diagnosed with the Patient Health Questionnaire).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1026
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Patients with severe mental disorders (e.g., bipolar disorder, personality
disorder), a history of frequent or recent suicide attempt(s), or high level of disability (as measured by the Sheehan Disability Scale) who seek Primary Care treatment. Also severe anxiety disorders (e.g., comorbid substance use disorders) and severe mood disorders (PHQ-9 >= 20). Patients who do not meet diagnostic criteria for a probable emotional disorder or do not reach the established PHQ cut-off points will be excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method