Brief Group Psychotherapy for Anxiety and Depression

Sponsor
Universidad de Córdoba (Other)
Overall Status
Completed
CT.gov ID
NCT04489641
Collaborator
(none)
100
1
2
11
9.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Brief Group Psychotherapy for Anxiety and Depression: A Randomized Controlled Trial of Efficacy and Mechanisms of Change
Actual Study Start Date :
Jan 16, 2020
Actual Primary Completion Date :
Nov 16, 2020
Actual Study Completion Date :
Dec 16, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Psychological treatment
Psychological treatment

Active Comparator: Treatment as usual (TAU)

Medication provided by a general practitioner.

Drug: Medication
Pharmacological intervention

Outcome Measures

Primary Outcome Measures

  1. Generalised Anxiety Disorder Assessment (GAD-7) [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) [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) [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) [12 weeks]

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

  5. Patient Health Questionnaire-Panic Disorder (PHQ-PD) [12 weeks]

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

Secondary Outcome Measures

  1. Emotional Regulation Questionnaire (ERQ) [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) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Anxiety

  • Depression

Exclusion Criteria:
  • Severe mental disroders

  • Drug abuse

  • Suicidal ideation/severe depression

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jorge Corpas Córdoba Andalucía Spain

Sponsors and Collaborators

  • Universidad de Córdoba

Investigators

  • Principal Investigator: Juan A. Moriana, Universidad de Córdoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jorge Corpas López, Clinical Professor, Universidad de Córdoba
ClinicalTrials.gov Identifier:
NCT04489641
Other Study ID Numbers:
  • Interventional
First Posted:
Jul 28, 2020
Last Update Posted:
Apr 29, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2021