Brief Group Psychotherapy for Anxiety and Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Affective Disorder
• Intervention / Treatment: Behavioral: Psychological treatment; Drug: Medication

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalucía
    • Córdoba, Andalucía, Spain
      • Jorge Corpas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Anxiety
• Depression

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2020
• Primary Completion (Actual): November 16, 2020
• Study Completion (Actual): December 16, 2020

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No