Brief Psychotherapies for Emotional Disorders in Primary and Secondary Care

NCT04343391 | Completed DMC

• 1 other identifier: Brief-Psychotherapies
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The present work aims to develop a randomized clinical trial with a sample of 150 patients diagnosed with at least one of the following emotional disorder: somatoform disorder, panic disorder, generalized anxiety disorder and depression disorder. Participants are tested by several self-reports related to the emocional disorders mentioned in a repeated measures design, pre and post treatment. The investigators think this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment for such pathologies in the Primary or Secondary Care context to improve the patient´s quality of life.

Conditions

Emotional Disorder

Outcome Measures

Primary Outcomes (7)

• Patient Health Questionnaire (PHQ-15)

  The Patient Health Questionnaire-Somatoform Disorder is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.The PHQ-15 is the somatization module, which scores each DSM-IV criteria as "0" (not bothered at all) to "2" (bothered a lot). The more score the more severity.

  10 weeks

• State-Trait Anxiety Inventory (STAI)

  The State-Trait Anxiety Inventory is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, \& Jacobs, 1983). It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress AnxietyForm Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level. Internal consistency coefficients for the scale have ranged from .86 to .95; test-retest reliability coefficients have ranged from .65 to .75 over a 2-month interval (Spielberger et al., 1983).

  10 weeks

• Beck Depression Inventory (BDI-II)

  The Beck Depression Inventory (second edition) is a widely used 21-item self-report inventory measuring the severity of depression in adolescents and adults. The BDI-II was revised in 1996 to be more consistent with DSM-IV criteria for depression. For example, individuals are asked to respond to each question based on a two-week time period rather than the one-week timeframe on the BDI. The BDI-II is widely used as an indicator of the severity of depression, but not as a diagnostic tool, and numerous studies provide evidence for its reliability and validity across different populations and cultural groups. The more score the more depression severity.

  10 weeks

• Patient Health Questionnaire (PHQ-9)

  The Patient Health Questionnaire-Depression is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The more score the more severity.

  10 weeks

• Patient Health Questionnaire (PHQ-PD)

  The Patient Health Questionnaire-Panic Disorder is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.The PHQ-PD is the panic disorder module, which scores each DSM-IV criteria as "yes" or "no". Higher scores mean greater severity of panic disorder.

  10 weeks

• Generalized Anxiety Disorder score (GAD-7)

  The Generalized Anxiety Disorder score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD.

  10 weeks

• Brief Symptom Inventory (BSI-18)

  The Brief Symptom Inventory contains the three six-item scales somatization, depression, and anxiety as well as the Global Severity Index (GSI), including all 18 items. The BSI-18 is the latest and shortest of the multidimensional versions of the Symptom-Checklist 90-R. The more score the more symptoms patients report.

  10 weeks

Study Arms (3)

Brief Individual Psychotherapy

EXPERIMENTAL

Individual brief psychological intervention by adaptation of the Guide NICE "Common Mental Health Disorders" (ISBN 978-1-84936-585-7) and the unified protocol for the trasndiagnostic treatment of the emotional disorders of Barlow (Boisseau, Farchione, Fairholme, Ellard, y Barlow, 2010). This intervention is provided by clinical psychologist in secondary care.

Behavioral: Brief transdiagnostic cognitive-behavioral therapy

Brief Group Psychotherapy

EXPERIMENTAL

Group brief psychological intervention by adaptation of the Guide NICE "Common Mental Health Disorders" (ISBN 978-1-84936-585-7) and the unified protocol for the trasndiagnostic treatment of the emotional disorders of Barlow (Boisseau, Farchione, Fairholme, Ellard, y Barlow, 2010). This intervention is provided by clinical psychologist in primary care.

Behavioral: Brief transdiagnostic cognitive-behavioral therapy

Treatment as usual

ACTIVE COMPARATOR

Medication provided by a general practitioner.

Drug: Pharmacological treatment

Interventions

Brief transdiagnostic cognitive-behavioral therapy BEHAVIORAL

Time-limited transdiagnostic evidence-based psychological treatment

Brief Group Psychotherapy; Brief Individual Psychotherapy

Pharmacological treatment DRUG

Treatment as usual in PC

Treatment as usual

Eligibility Criteria

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

You may qualify if:

• Emotional Disorder

You may not qualify if:

• Severe mental disorder
• Substance use disorder
• Severe depression

Sponsors & Collaborators

• Universidad de Córdoba: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Universidad de Córdoba

Córdoba, Córdoba, 14071, Spain

Location

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reseracher in Clinical Psychology

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: January 15, 2020
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

ES (1)