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Brief Evidence-based Psychological Treatments for Emotional Disorders (PsycBrief)

Primary Purpose

Anxiety Disorders, Depression, Somatoform Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Brief individual psychotherapy
Brief group psychotherapy
Combined intervention
Minimum psychological intervention
Usual treatment
Sponsored by
Universidad de Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Common Mental Disorders, Brief Psychological Treatments, Primary Care, Randomized Clinical Trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Emotional disorders

Exclusion Criteria:

  • Severe mental disorder
  • Drug abuse
  • Severe depression

Sites / Locations

  • Universidad de Córdoba

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Arm Description

Outcomes

Primary Outcome Measures

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.
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).
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).
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.
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).
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".
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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2017
Last Updated
April 28, 2021
Sponsor
Universidad de Córdoba
Collaborators
Ministerio de Economía y Competitividad, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT03286881
Brief Title
Brief Evidence-based Psychological Treatments for Emotional Disorders
Acronym
PsycBrief
Official Title
Brief Evidence-based Psychological Treatments for Emotional Disorders. A Randomized Clinical Trial in Primary and Secondary Care.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2017 (Actual)
Primary Completion Date
April 15, 2018 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Córdoba
Collaborators
Ministerio de Economía y Competitividad, Spain

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Nowadays, the heavy demands placed on health systems exceed the resources in many developed countries. So-called "common mental disorders" and their mostly pharmacological treatment are, in no small part, responsible for this situation. The cost that these disorders generate to the public health service is very high and they are usually associated with other issues like hyperfrequentation and side effects. However, research indicates that psychological treatment should be the first step when caring for these types of problems. We expect that the results show that extensive psychological therapy and combined treatment were the most effective. Nevertheless, brief psychological treatment is expected to be the most efficient in cost-benefit terms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression, Somatoform Disorders, Common Mental Disorders
Keywords
Common Mental Disorders, Brief Psychological Treatments, Primary Care, Randomized Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Experimental
Arm Title
Group 3
Arm Type
Experimental
Arm Title
Group 4
Arm Type
Experimental
Arm Title
Group 5
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Brief individual psychotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Brief group psychotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Combined intervention
Intervention Description
Traditional psychotherapy and medication provided by a clinical psychologist and a psychiatrist in secondary care.
Intervention Type
Other
Intervention Name(s)
Minimum psychological intervention
Intervention Description
Psychoeducation and bibliotherapy provided by a trained general practitioner in primary care.
Intervention Type
Other
Intervention Name(s)
Usual treatment
Intervention Description
Medication provided by a general practitioner.
Primary Outcome Measure Information:
Title
Generalised Anxiety Disorder Assessment (GAD-7)
Description
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.
Time Frame
12 weeks
Title
The State-Trait Anxiety Inventory (STAI)
Description
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).
Time Frame
12 weeks
Title
The Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
12 weeks
Title
Beck Depression Inventory-Second Edition (BDI-II)
Description
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.
Time Frame
12 weeks
Title
The Patient Health Questionnaire (PHQ-15)
Description
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).
Time Frame
12 weeks
Title
The Patient Health Questionnaire (PHQ-PD)
Description
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".
Time Frame
12 weeks
Title
Brief Symptom Inventory 18 (BSI-18)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Emotional disorders Exclusion Criteria: Severe mental disorder Drug abuse Severe depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Antonio Moriana E
Organizational Affiliation
Universidad de Cordoba
Official's Role
Study Director
Facility Information:
Facility Name
Universidad de Córdoba
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
14071
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
30671005
Citation
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.
Results Reference
derived

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Brief Evidence-based Psychological Treatments for Emotional Disorders

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