Back to resultsBrief Group Psychotherapy for Anxiety and Depression
Primary Purpose
Affective Disorder
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psychological treatment
Medication
Sponsored by
About this trial
This is an interventional treatment trial for Affective Disorder
Eligibility Criteria
Inclusion Criteria:
- Anxiety
- Depression
Exclusion Criteria:
- Severe mental disroders
- Drug abuse
- Suicidal ideation/severe depression
Sites / Locations
- Jorge Corpas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Brief group psychotherapy
Treatment as usual (TAU)
Arm Description
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.
Medication provided by a general practitioner.
Outcomes
Primary Outcome Measures
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.
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).
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.
The Patient Health Questionnaire (PHQ-15)
It asseses somatoform symptoms. Scores could vary between 0-30 points.
Patient Health Questionnaire-Panic Disorder (PHQ-PD)
It measures panic disorder symotmos. Scores vould vary between 0-15 points.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04489641
Brief Title
Brief Group Psychotherapy for Anxiety and Depression
Official Title
Brief Group Psychotherapy for Anxiety and Depression: A Randomized Controlled Trial of Efficacy and Mechanisms of Change
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
November 16, 2020 (Actual)
Study Completion Date
December 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Córdoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Affective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief group psychotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual (TAU)
Arm Type
Active Comparator
Arm Description
Medication provided by a general practitioner.
Intervention Type
Behavioral
Intervention Name(s)
Psychological treatment
Intervention Description
Psychological treatment
Intervention Type
Drug
Intervention Name(s)
Medication
Intervention Description
Pharmacological intervention
Primary Outcome Measure Information:
Title
Generalised Anxiety Disorder Assessment (GAD-7)
Description
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.
Time Frame
12 weeks
Title
The Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
12 weeks
Title
Beck Depression Inventory-Second Edition (BDI-II)
Description
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.
Time Frame
12 weeks
Title
The Patient Health Questionnaire (PHQ-15)
Description
It asseses somatoform symptoms. Scores could vary between 0-30 points.
Time Frame
12 weeks
Title
Patient Health Questionnaire-Panic Disorder (PHQ-PD)
Description
It measures panic disorder symotmos. Scores vould vary between 0-15 points.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Emotional Regulation Questionnaire (ERQ)
Description
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.
Time Frame
12 weeks
Title
Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
Description
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.
Time Frame
12 weeks
Title
Ruminative Response Scale-10 (RRS-10)
Description
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.
Time Frame
12 weeks
Title
Metacognition Questionnaire-30 (MCQ-30)
Description
This instrument has been used to assess metacognitive beliefs. It consists of 30 items that are responded on a 4-point Likert-type scale.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Anxiety
Depression
Exclusion Criteria:
Severe mental disroders
Drug abuse
Suicidal ideation/severe depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan A. Moriana
Organizational Affiliation
Universidad de Córdoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jorge Corpas
City
Córdoba
State/Province
Andalucía
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Brief Group Psychotherapy for Anxiety and Depression
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