Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04489641
Other study ID # Interventional
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 16, 2020
Est. completion date December 16, 2020

Study information

Verified date April 2021
Source Universidad de Córdoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 16, 2020
Est. primary completion date November 16, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Anxiety - Depression Exclusion Criteria: - Severe mental disroders - Drug abuse - Suicidal ideation/severe depression

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychological treatment
Psychological treatment
Drug:
Medication
Pharmacological intervention

Locations

Country Name City State
Spain Jorge Corpas Córdoba Andalucía

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary The Patient Health Questionnaire (PHQ-15) It asseses somatoform symptoms. Scores could vary between 0-30 points. 12 weeks
Primary Patient Health Questionnaire-Panic Disorder (PHQ-PD) It measures panic disorder symotmos. Scores vould vary between 0-15 points. 12 weeks
Secondary Emotional Regulation Questionnaire (ERQ) It evaluates the tendency to regulate emotions. It consists of 10 items and participants have to respond according to a 7-points Likert scale. It has two subscales: reappraisal and suppression (six and four items respectively). The reappraisal subscale assesses the ability to change negative emotions while the suppression subscale assesses the tendency to repress and hide negative emotions. 12 weeks
Secondary Penn State Worry Questionnaire-Abbreviated (PSWQ-A) It assesses the tendency to experience worry. It consists of eight items and patients have to respond according to a 5-point Likert-type scale. 12 weeks
Secondary Ruminative Response Scale-10 (RRS-10) The RRS is the most used measure of rumination. The short version consists of 10 items that are responded on a 4-point Likert-type scale. 12 weeks
Secondary Metacognition Questionnaire-30 (MCQ-30) This instrument has been used to assess metacognitive beliefs. It consists of 30 items that are responded on a 4-point Likert-type scale. 12 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04136054 - Better Sleep in Psychiatric Care - Anxiety and Affective Disorders N/A
Recruiting NCT05461885 - Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: The Vega Trial N/A
Completed NCT01721824 - The Effect of IPS-MA- A Modified Early Supported Employment Intervention for Individuals With Mood or Anxiety Disorders N/A
Recruiting NCT05869409 - Physical Activity, Psychopathology, and Quality of Life in People With Psychotic or Affective Disorders
Active, not recruiting NCT05249309 - Naturalistic Study of Ketamine in the Treatment of Depression
Completed NCT03235908 - Copeptin in Outcome Prediction of an Acute Psychotic Episode
Not yet recruiting NCT04288609 - Effectiveness of a Cognitive Remediation Intervention Based on Virtual Reality for Promotion of Cognitive Functioning and Participation in Daily Life Among Persons With Affective Disorder N/A
Recruiting NCT03294525 - Towards Neurobiology-based Diagnosis and Treatment of Affective Disorders
Recruiting NCT05596461 - New Techniques for Diagnosis and Treatment of Cognitive Impairment in Affective Disorder N/A
Completed NCT03609515 - Patient-controlled Admissions in Inpatient Mental Health Services N/A