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Clinical Trials/NCT04489641
NCT04489641
Completed
Not Applicable

Brief Group Psychotherapy for Anxiety and Depression: A Randomized Controlled Trial of Efficacy and Mechanisms of Change

Universidad de Córdoba1 site in 1 country100 target enrollmentJanuary 16, 2020

Overview

Phase
Not Applicable
Intervention
Psychological treatment
Conditions
Affective Disorder
Sponsor
Universidad de Córdoba
Enrollment
100
Locations
1
Primary Endpoint
Generalised Anxiety Disorder Assessment (GAD-7)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The present work aims to develop a randomized clinical trial with a sample of 100 patients diagnosed with anxiety and depression in primary care. All participants are tested by several self-reports related to emotional disorders in a repeated measures design, pre and post treatment. It is our aim this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment in Primary Care. In addition, emotional regulation will be assessed and examined as a key factor in the clinical improvement.

Registry
clinicaltrials.gov
Start Date
January 16, 2020
End Date
December 16, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad de Córdoba
Responsible Party
Principal Investigator
Principal Investigator

Jorge Corpas López

Clinical Professor

Universidad de Córdoba

Eligibility Criteria

Inclusion Criteria

  • Depression

Exclusion Criteria

  • Severe mental disroders
  • Drug abuse
  • Suicidal ideation/severe depression

Arms & Interventions

Brief group psychotherapy

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 et al., 2010). This intervention is provided by clinical psychologist in primary care.

Intervention: Psychological treatment

Treatment as usual (TAU)

Medication provided by a general practitioner.

Intervention: Medication

Outcomes

Primary Outcomes

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 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).

The Patient Health Questionnaire (PHQ-15)

Time Frame: 12 weeks

It asseses somatoform symptoms. Scores could vary between 0-30 points.

Patient Health Questionnaire-Panic Disorder (PHQ-PD)

Time Frame: 12 weeks

It measures panic disorder symotmos. Scores vould vary between 0-15 points.

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.

Secondary Outcomes

  • Emotional Regulation Questionnaire (ERQ)(12 weeks)
  • Penn State Worry Questionnaire-Abbreviated (PSWQ-A)(12 weeks)
  • Ruminative Response Scale-10 (RRS-10)(12 weeks)
  • Metacognition Questionnaire-30 (MCQ-30)(12 weeks)

Study Sites (1)

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