Brief Evidence-based Psychological Treatments for Common Mental Disorders (PsycBrief)
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|ClinicalTrials.gov Identifier: NCT03286881|
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders Depression Somatoform Disorders Common Mental Disorders||Other: Brief psychotherapy Other: Extensive psychotherapy Other: Combined intervention Other: Minimum psychological intervention Other: Usual treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||Brief Evidence-based Psychological Treatments for Common Mental Disorders. A Randomized Clinical Trial in Primary and Secondary Care.|
|Study Start Date :||January 15, 2017|
|Estimated Primary Completion Date :||January 15, 2018|
|Estimated Study Completion Date :||January 15, 2019|
|Experimental: Group 1||
Other: Brief psychotherapy
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.
|Experimental: Group 2||
Other: Extensive psychotherapy
Usual psychological intervention in secondary care provided by a clinical psychologist.
|Experimental: Group 3||
Other: Combined intervention
Extensive psychotherapy and medication provided by a clinical psychologist and a psychiatrist.
|Experimental: Group 4||
Other: Minimum psychological intervention
Psychoeducation and bibliotherapy provided by a trained general practitioner in primary care.
|Active Comparator: Group 5||
Other: Usual treatment
Medication provided by a general practitioner.
- Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: 12 weeks ]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) [ Time Frame: 12 weeks ]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) [ Time Frame: 12 weeks ]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) [ Time Frame: 12 weeks ]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) [ Time Frame: 12 weeks ]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) [ Time Frame: 12 weeks ]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) [ Time Frame: 12 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286881
|Contact: Jorge C Lópezfirstname.lastname@example.org|
|Contact: Juan Antonio Morianaemail@example.com|
|Universidad de Córdoba||Recruiting|
|Cordoba, Córdoba, Spain, 14071|
|Contact: Jorge C López 654732504|
|Principal Investigator: Juan Antonio M Elvira|
|Study Director:||Juan Antonio Moriana E||Universidad de Cordoba|