Treating Emotional Disorders in Primary Care With Psychological Techniques

NCT01903096 | Completed Phase 4

• 2 other identifiers: AP1051620122013-001955-11
• Study Type: interventional
• Target: 1,126
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Panic disorder; Generalized anxiety disorder; Social phobia; Specific phobia; Major depressive disorder; Dysthymia; Somatizations disorder; Pain disorder

Outcome Measures

Primary Outcomes (3)

• Anxiety symptoms after psychological treatment versus Primary Care usual treatment.

  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.

  Up to two years

• Depressive symptoms after psychological treatment versus Primary Care usual treatment.

  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.

  Up to two years.

• Somatic symptoms after psychological treatment versus Primary Care usual treatment.

  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.

  Up to two years.

Secondary Outcomes (4)

• Cognitive factors after psychological treatment versus Primary Care usual treatment.

  Up to two years

• Level of impairment after psychological treatment versus Primary Care usual treatment.

  Up to two years

• Quality of life after psychological treatment versus Primary Care usual treatment.

  Up to two years

• Frequency of primary care visits after psychological treatment versus Primary Care usual treatment.

  Up to 18 months

Other Outcomes (1)

• Treatment satisfaction

  Up to 18 months

Study Arms (2)

Cognitive Behavioral Treatment (CBT)

EXPERIMENTAL

Cognitive Behavioral Treatment. Seven 90-minute sessions of group treatment along 24 weeks.

Behavioral: Cognitive Behavioral Treatment

Treatment-As-Usual (TAU)

ACTIVE COMPARATOR

Primary Care Treatment As Usual

Drug: Primary Care Treatment As Usual

Interventions

Cognitive Behavioral Treatment BEHAVIORAL

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

Also known as: CBT (Cognitive-Behavioral Treatment)

Cognitive Behavioral Treatment (CBT)

Primary Care Treatment As Usual DRUG

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

Also known as: Antidepressants, antianxiety, sleep and pain medication.

Treatment-As-Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo: lead
• Ministry of Health, Spain: collaborator

Study Sites (1)

Complutense University of Madrid

Madrid, 28223, Spain

Location

Related Publications (4)

• Cano-Vindel A. Los desórdenes emocionales en Atención Primaria [Emotional Disorders in Primary Care]. Ansiedad y Estrés 2011;17(1):73-95.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

Related Links

• Spanish Society for the Investigation of Anxiety and Stress

MeSH Terms

Conditions

Anxiety Disorders; Mood Disorders; Somatoform Disorders; Panic Disorder; Generalized Anxiety Disorder; Phobia, Social; Phobia, Specific; Depressive Disorder, Major; Dysthymic Disorder

Interventions

Antidepressive Agents; Sleep; Acetaminophen

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders; Depressive Disorder

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Antonio R Cano-Vindel, Professor

  Universidad Complutense de Madrid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A computer-generated allocation sequence was used to randomly assign patients (1:1) to receive either TD-GCBT plus TAU or TAU alone. All patients were assigned a code for blinding purposes and then the patient characteristics were sent to one of the investigators to check that they met the inclusion criteria. Patients who met the inclusion criteria were then randomized as described above.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, controlled, two arm single-blind trial

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 19, 2013
• Study Start: January 14, 2014
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

ES (1)