Skip to main content
OpenTrials
Completed

NCT Number: NCT04489641

Brief Group Psychotherapy for Anxiety and Depression

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Affective Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jorge Corpas

Córdoba, Andalusia, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Anxiety
  • Depression

Exclusion criteria

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

Treatment and study plan

Psychological treatment

Behavioral

Psychological treatment

medication

Drug

Pharmacological intervention

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. The Patient Health Questionnaire (PHQ-15)

    Time frame: 12 weeks

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

  5. Patient Health Questionnaire-Panic Disorder (PHQ-PD)

    Time frame: 12 weeks

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

Secondary outcomes

  1. Emotional Regulation Questionnaire (ERQ)

    Time frame: 12 weeks

    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.

  2. Penn State Worry Questionnaire-Abbreviated (PSWQ-A)

    Time frame: 12 weeks

    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.

  3. Ruminative Response Scale-10 (RRS-10)

    Time frame: 12 weeks

    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.

  4. Metacognition Questionnaire-30 (MCQ-30)

    Time frame: 12 weeks

    This instrument has been used to assess metacognitive beliefs. It consists of 30 items that are responded on a 4-point Likert-type scale.

Sponsors and collaborators

Lead sponsor

Universidad de Córdoba

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2020
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.