Treating Emotional Disorders in Primary Care With Psychological Techniques

NCT01903096 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1126

Last updated 2020-03-10

No results posted yet for this study

Summary

The strong demand for primary care (PC) services in Spain exceeds resources. Part of this demand is due to the increasing number of anxiety, depression, and somatization disorders that affect the general population. These disorders, commonly known as emotional disorders, are very common in Spanish PC settings, they are poorly detected by physicians, rarely receive adequate treatment (if they receive treatment it is mostly drugs instead of psychological treatment), they generate a highly frequent use of PC services, a greater burden than physical diseases and tend to become chronic without treatment.

Other countries have successfully put psychological techniques in PC into practice (in the United Kingdom the program known as "Improving Access to Psychological Therapies" has obtained very positive results) in order to correctly diagnose and treat emotional disorders. The results obtained in terms of symptoms, quality of life, diagnosis, etc., have been better than the usual treatment offered in PC services, involving no side effects, fewer relapses, and lower costs in the long term.

The general aim of this study is to test how well a psychological treatment program for anxiety, depression, and somatization disorders works in PC and to compare the results obtained after seven 90-minute group sessions (every to two to four weeks approximately, for a period of 24 weeks) with the usual treatment offered in Spanish PC services. Similar results to the ones already obtained in other countries are expected to be found.

Approximately 1130 adults, regardless of their age and sex, with an anxiety, depression and/or somatization disorder (diagnosed with a simple and short questionnaire) will participate in this study.

Participation will be voluntary and confidentiality will be guaranteed. Half of the participants in the study will be randomly assigned to receive their usual care and the other half will receive psychological treatment, within the same health care centre. Since it is a "double-blind" study, neither the health professional nor the patient will know which treatment will be applied. Psychological assessments will be carried out before and after receiving treatment and participants will be followed up at 3, 6 and 12 months.

Participation will pose no risks different from the typically present when receiving usual treatment. The aim of this study will be to maximize benefits and reduce potential harms (principle of proportionality).

Conditions

  • Anxiety Disorders
  • Mood Disorders
  • Somatization Disorder
  • Pain Disorder

Interventions

BEHAVIORAL

Cognitive Behavioral Treatment

Seven ninety-minute sessions of evidence-based psychological techniques designed to treat anxiety, depression and somatization disorders during a period of 24 weeks.

DRUG

Primary Care Treatment As Usual

Usual treatment offered in Primary Care Services: depending on the diagnoses, patients will be prescribed different medications until symptoms disappear.

Sponsors & Collaborators

  • Ministry of Health, Spain

    collaborator OTHER_GOV
  • Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo

    lead OTHER

Principal Investigators

  • Antonio R Cano-Vindel, Professor · Universidad Complutense de Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-14
Primary Completion
2018-07-30
Completion
2019-07-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01903096 on ClinicalTrials.gov