Brief Evidence-based Psychological Treatments for Emotional Disorders

NCT03286881 | Completed DMC

• 1 other identifier: PSI2014-56368-R
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

The present work aims to develop a randomized clinical trial with a sample of 165 patients diagnosed with an emotional disorder. All participants are tested by several self-reports related to common mental disorders in a repeated measures design, pre and post treatment as well as a six month follow up. We 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 while simultaneously reducing costs.

Conditions

Anxiety Disorders; Depression; Somatoform Disorders; Common Mental Disorders

Keywords

Common Mental Disorders; Brief Psychological Treatments; Primary Care; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (7)

• Generalised Anxiety Disorder Assessment (GAD-7)

  The GAD-7 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.

  12 weeks

• The State-Trait Anxiety Inventory (STAI)

  The State-Trait Anxiety Inventory (STAI) 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).

  12 weeks

• The Patient Health Questionnaire (PHQ-9)

  The Patient Health Questionnaire (PHQ) 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).

  12 weeks

• Beck Depression Inventory-Second Edition (BDI-II)

  The BDI-II 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.

  12 weeks

• The Patient Health Questionnaire (PHQ-15)

  The Patient Health Questionnaire (PHQ) 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).

  12 weeks

• The Patient Health Questionnaire (PHQ-PD)

  The Patient Health Questionnaire (PHQ) 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".

  12 weeks

• Brief Symptom Inventory 18 (BSI-18)

  The BSI-18 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.

  12 weeks

Study Arms (5)

Group 1

EXPERIMENTAL

Other: Brief individual psychotherapy

Group 2

EXPERIMENTAL

Other: Brief group psychotherapy

Group 3

EXPERIMENTAL

Other: Combined intervention

Group 4

EXPERIMENTAL

Other: Minimum psychological intervention

Group 5

ACTIVE COMPARATOR

Other: Usual treatment

Interventions

Brief individual psychotherapy OTHER

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.

Group 1

Brief group psychotherapy OTHER

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.

Group 2

Combined intervention OTHER

Traditional psychotherapy and medication provided by a clinical psychologist and a psychiatrist in secondary care.

Group 3

Minimum psychological intervention OTHER

Psychoeducation and bibliotherapy provided by a trained general practitioner in primary care.

Group 4

Usual treatment OTHER

Medication provided by a general practitioner.

Group 5

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 disorders

You may not qualify if:

• Severe mental disorder
• Drug abuse
• 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

Related Publications (1)

• Galvez-Lara M, Corpas J, Vencesla JF, Moriana JA. Evidence-Based Brief Psychological Treatment for Emotional Disorders in Primary and Specialized Care: Study Protocol of a Randomized Controlled Trial. Front Psychol. 2019 Jan 8;9:2674. doi: 10.3389/fpsyg.2018.02674. eCollection 2018.

  PMID: 30671005 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Somatoform Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Juan Antonio Moriana E

  Universidad de Cordoba

  STUDY DIRECTOR

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: Investigator

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 19, 2017
• Study Start: January 15, 2017
• Primary Completion: April 15, 2018
• Study Completion: January 15, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

ES (1)