Brief Group Psychotherapy for Anxiety and Depression

NCT04489641 | Completed DMC

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Affective Disorder

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• The Patient Health Questionnaire (PHQ-15)

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

  12 weeks

• Patient Health Questionnaire-Panic Disorder (PHQ-PD)

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

  12 weeks

Secondary Outcomes (4)

• 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 Arms (2)

Brief group psychotherapy

EXPERIMENTAL

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

Treatment as usual (TAU)

ACTIVE COMPARATOR

Medication provided by a general practitioner.

Drug: Medication

Interventions

Psychological treatment BEHAVIORAL

Psychological treatment

Brief group psychotherapy

Medication DRUG

Pharmacological intervention

Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anxiety
• Depression

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Córdoba: lead

Study Sites (1)

Jorge Corpas

Córdoba, Andalusia, Spain

Location

MeSH Terms

Conditions

Mood Disorders

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Juan A. Moriana

  Universidad de Córdoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 28, 2020
• Study Start: January 16, 2020
• Primary Completion: November 16, 2020
• Study Completion: December 16, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

ES (1)