NCT01903096: PsychPC

Treating Emotional Disorders in Primary Care With Psychological Techniques

Completed Phase 4 Last updated 10 March 2020

What this trial tests

Phase 4 trial testing Cognitive Behavioral Treatment in Anxiety Disorders in 1,126 participants. Completed in 30 July 2019.

Timeline

14 January 2014

Primary endpoint
30 July 2018

30 July 2019

Quick facts

Lead sponsor	Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,126
Start date	14 January 2014
Primary completion	30 July 2018
Estimated completion	30 July 2019
Sites	1 location across Spain

Drugs / interventions tested

• Cognitive Behavioral Treatment
• Primary Care Treatment As Usual — full drug profile →

Conditions studied

• Anxiety Disorders — all drugs for Anxiety Disorders →
• Mood Disorders — all drugs for Mood Disorders →
• Somatization Disorder — all drugs for Somatization Disorder →
• Pain Disorder — all drugs for Pain Disorder →

Sponsor

Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo — full company profile →

Who can join

18 and older, any sex, with Anxiety Disorders or Mood Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.