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Treating Emotional Disorders in Primary Care With Psychological Techniques (PsychPC)

This study is currently recruiting participants.
Verified April 2017 by Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo
Sponsor:
ClinicalTrials.gov Identifier:
NCT01903096
First Posted: July 19, 2013
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ministry of Health, Spain
Information provided by (Responsible Party):
Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo
  Purpose

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).


Condition Intervention
Anxiety Disorders Mood Disorders Somatization Disorder Pain Disorder Behavioral: Cognitive Behavioral Treatment Drug: Primary Care Treatment As Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Pilot Study to Treat Emotional Disorders in Primary Care With Evidence-based Psychological Techniques: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo:

Primary Outcome Measures:
  • Anxiety symptoms after psychological treatment versus Primary Care usual treatment. [ Time Frame: Up to two years ]
    Diagnostic and Statistical Manual of Mental Disorders -Fourth Edition (DSM-IV) clinical symptoms of anxiety (total frequency scores in anxiety as measured by the Patient Health Questionnaire) as reported by patients after receiving psychological treatment or usual treatment.

  • Depressive symptoms after psychological treatment versus Primary Care usual treatment. [ Time Frame: Up to two years. ]
    Diagnostic and Statistical Manual of Mental Disorders -Fourth Edition (DSM-IV) clinical symptoms of depression (total frequency scores in depression as measured by the Patient Health Questionnaire) as reported by patients after receiving psychological treatment or usual treatment.

  • Somatic symptoms after psychological treatment versus Primary Care usual treatment. [ Time Frame: Up to two years. ]
    Diagnostic and Statistical Manual of Mental Disorders -Fourth Edition (DSM-IV) somatic symptoms (total frequency scores in somatic symptoms as measured by the Patient Health Questionnaire) as reported by patients after receiving psychological treatment or usual treatment.


Secondary Outcome Measures:
  • Cognitive factors after psychological treatment versus Primary Care usual treatment. [ Time Frame: Up to two years ]
    Pre-post treatment differences at post treatment and at 3, 6 and 12 month follow-up in cognitive tests scores (composite score designed to assess ruminative processes, pathological worry, attentional and interpretive biases, emotion regulation strategies and metacognitive beliefs) as reported by patients after receiving psychological treatment or usual treatment.

  • Level of impairment after psychological treatment versus Primary Care usual treatment. [ Time Frame: Up to two years ]
    Pre-post treatment differences at post treatment and at 3, 6 and 12 month follow-up in work, family and social impairment (as measured by the Sheehan Disability Scale) as reported by patients after receiving psychological treatment or usual treatment.

  • Quality of life after psychological treatment versus Primary Care usual treatment. [ Time Frame: Up to two years ]
    Pre-post treatment differences at post treatment and at 3, 6 and 12 month follow-up in physical health, psychological, social, and environmental quality of life (as measured by the different World Health Organization Quality of Life; WHOQOL-BREF scales) as reported by patients after receiving psychological treatment or usual treatment.

  • Frequency of primary care visits after psychological treatment versus Primary Care usual treatment. [ Time Frame: Up to 18 months ]
    Frequency of primary care visits after psychological treatment versus Primary Care usual treatment.


Other Outcome Measures:
  • Treatment satisfaction [ Time Frame: Up to 18 months ]
    Treatment satisfaction after receiving psychological treatment versus treatment as usual.


Estimated Enrollment: 1126
Study Start Date: March 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Treatment (CBT)
Cognitive Behavioral Treatment. Seven 90-minute sessions of group treatment along 24 weeks.
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.
Other Name: CBT (Cognitive-Behavioral Treatment)
Active Comparator: Treatment-As-Usual (TAU)
Primary Care Treatment As Usual
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.
Other Name: Antidepressants, antianxiety, sleep and pain medication.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any adult patient seeking Primary Care treatment at any of the selected sites in Spain with a probable anxiety, mood and/or somatisation disorder (diagnosed with the Patient Health Questionnaire) may voluntarily participate in the study regardless of his/her age and sex.

Exclusion Criteria:

  • Patients with severe mental disorders (e.g., bipolar disorder, personality disorder)
  • Patients with a history of frequent or recent suicide attempt(s)
  • Patients with a high level of disability (as measured by the Sheehan Disability Scale) who seek Primary Care treatment.
  • Patients with severe anxiety disorders (e.g., comorbid substance use disorders) and severe mood disorders (Patient Health Questionnaire; PHQ-9 total score >= 20).
  • Patients who do not meet diagnostic criteria for a probable emotional disorder or do not reach the established PHQ cut-off points.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903096


Contacts
Contact: Antonio R Cano-Vindel, Professor 34607705740 canovindel@psi.ucm.es
Contact: Cristina M Wood, PhD. 34629056921 wood@psi.ucm.es

Locations
Spain
Complutense University of Madrid Recruiting
Madrid, Spain, 28223
Contact: Cristina M Wood, PhD.    34629056921    wood@psi.ucm.es   
Principal Investigator: Antonio R Cano-Vindel, Professor         
Sub-Investigator: Roger M Muñoz, PhD.         
Sub-Investigator: Cristina M Wood, PhD.         
Sponsors and Collaborators
Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo
Ministry of Health, Spain
Investigators
Study Director: Antonio R Cano-Vindel, Professor Complutense University of Madrid
  More Information

Additional Information:
Publications:
Cano-Vindel A. Los desórdenes emocionales en Atención Primaria [Emotional Disorders in Primary Care]. Ansiedad y Estrés 2011;17(1):73-95.
Cano-Vindel A; Wood CM; Dongil E; Latorre JM. El trastorno de pánico en Atención Primaria [Panic disorder in Primary Care]. Papeles del Psicólogo 2011;32(3):3-13.
Cano-Vindel A. Bases teóricas y apoyo empírico de la intervención psicológica sobre los desórdenes emocionales en Atención Primaria. Una actualización [Theoretical and empirical evidence supporting a psychological intervention for emotional disorders in Primary Care. An update]. Ansiedad y Estrés 2011;17(2-3):157-184.
Cano-Vindel A; Dongil-Collado E; Salguero JM; Wood CM. Intervención cognitivo-conductual en los trastornos de ansiedad: una actualización [Cognitive-behavioral treatment for anxiety disorders: an update]. Informació Psicològica 2011;102:4-27.

Responsible Party: Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo
ClinicalTrials.gov Identifier: NCT01903096     History of Changes
Other Study ID Numbers: AP105162012
2013-001955-11 ( EudraCT Number )
First Submitted: July 2, 2013
First Posted: July 19, 2013
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo:
Panic disorder
Generalized anxiety disorder
Social phobia
Specific phobia
Major depressive disorder
Dysthymia
Somatizations disorder
Pain disorder

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Mood Disorders
Somatoform Disorders
Pathologic Processes
Mental Disorders