Anxiety DisordersPsycBriefNCT03286881
Brief Evidence-based Psychological Treatments for Emotional Disorders
A study testing Brief individual psychotherapy, Brief group psychotherapy and Combined intervention in people with Anxiety Disorders and Depression, run by Universidad de Córdoba at 1 site in Spain.
Trial summary
The present work aims to develop a randomized clinical trial with a sample of 165 patients diagnosed with an emotional disorder. All participants are tested by several self-reports related to common mental disorders in a repeated measures design, pre and post treatment as well as a six month follow up. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders, Depression, Somatoform Disorders
- What is being tested?
- Brief individual psychotherapy, Brief group psychotherapy and Combined intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2017to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emotional disorders
Who cannot join
- Severe mental disorder
- Drug abuse
- Severe depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Evidence-based Psychological Treatments for Emotional Disorders. A Randomized Clinical Trial in Primary and Secondary Care.
The present work aims to develop a randomized clinical trial with a sample of 165 patients diagnosed with an emotional disorder. All participants are tested by several self-reports related to common mental disorders in a repeated measures design, pre and post treatment as well as a six month follow up. We think this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment for such pathologies in the Primary or Secondary Care context to improve the patient´s quality of life while simultaneously reducing costs.
Read the detailed description
Nowadays, the heavy demands placed on health systems exceed the resources in many developed countries. So-called "common mental disorders" and their mostly pharmacological treatment are, in no small part, responsible for this situation. The cost that these disorders generate to the public health service is very high and they are usually associated with other issues like hyperfrequentation and side effects. However, research indicates that psychological treatment should be the first step when caring for these types of problems. We expect that the results show that extensive psychological therapy and combined treatment were the most effective. Nevertheless, brief psychological treatment is expected to be the most efficient in cost-benefit terms.
- Being tested
- Brief individual psychotherapy, Brief group psychotherapy, Combined intervention, Minimum psychological intervention, Usual treatment
- Keywords
- Common Mental Disorders, Brief Psychological Treatments, Primary Care, Randomized Clinical Trial
- Medical subject headings
- Anxiety Disorders, Depression, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief individual psychotherapyOther
Individual 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, Farchione, Fairholme, Ellard, y Barlow, 2010). This intervention is provided by clinical psychologist in secondary care.
Brief group psychotherapyOther
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, Farchione, Fairholme, Ellard, y Barlow, 2010). This intervention is provided by clinical psychologist in primary care.
Combined interventionOther
Traditional psychotherapy and medication provided by a clinical psychologist and a psychiatrist in secondary care.
Minimum psychological interventionOther
Psychoeducation and bibliotherapy provided by a trained general practitioner in primary care.
Usual treatmentOther
Medication provided by a general practitioner.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Other: Brief individual psychotherapy |
| Group 2 | Experimental | Not described Receives: Other: Brief group psychotherapy |
| Group 3 | Experimental | Not described Receives: Other: Combined intervention |
| Group 4 | Experimental | Not described Receives: Other: Minimum psychological intervention |
| Group 5 | Active comparator | Not described Receives: Other: Usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
The State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, \& Jacobs, 1983). It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress AnxietyForm Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level. Internal consistency coefficients for the scale have ranged from .86 to .95; test-retest reliability coefficients have ranged from .65 to .75 over a 2-month interval (Spielberger et al., 1983).
Measured: 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).
Measured: 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.
Measured: 12 weeks
The Patient Health Questionnaire (PHQ-15)
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.The PHQ-15 is the somatization module, which scores each DSM-IV criteria as "0" (not bothered at all) to "2" (bothered a lot).
Measured: 12 weeks
The Patient Health Questionnaire (PHQ-PD)
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.The PHQ-PD is the panic disorder module, which scores each DSM-IV criteria as "yes" or "no".
Measured: 12 weeks
Brief Symptom Inventory 18 (BSI-18)
The BSI-18 contains the three six-item scales somatization, depression, and anxiety as well as the Global Severity Index (GSI), including all 18 items. The BSI-18 is the latest and shortest of the multidimensional versions of the Symptom-Checklist 90-R.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start15 Jan 2017
- Primary completion15 Apr 2018
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Principal investigator, Jorge Corpas López, Universidad de Córdoba
- Investigators
- Juan Antonio Moriana E, Study director, Universidad de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286881
- Sponsor's protocol ID
- PSI2014-56368-R
- Acronym
- PsycBrief
- Status last verified
- Apr 2021
- First submitted
- 12 Sep 2017
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Galvez-Lara M, Corpas J, Vencesla JF, Moriana JA. Evidence-Based Brief Psychological Treatment for Emotional Disorders in Primary and Specialized Care: Study Protocol of a Randomized Controlled Trial. Front Psychol. 2019 Jan 8;9:2674. doi: 10.3389/fpsyg.2018.02674. eCollection 2018.
PubMed 30671005
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Evidence-based Psychological Treatments for Emotional Disorders. A Randomized Clinical Trial in Primary and Secondary Care.
- ClinicalTrials.gov ID
- NCT03286881
- Acronym / sponsor ID
- PsycBrief / PSI2014-56368-R
- Keywords
- Common Mental Disorders, Brief Psychological Treatments, Primary Care, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Universidad de CórdobaUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present work aims to develop a randomized clinical trial with a sample of 165 patients diagnosed with an emotional disorder. All participants are tested by several self-reports related to common mental disorders in a repeated measures design, pre and post treatment as well as a six month follow up. We think this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment for such pathologies in the Primary or Secondary Care context to improve the patient´s quality of life while simultaneously reducing costs.
Detailed description
Nowadays, the heavy demands placed on health systems exceed the resources in many developed countries. So-called "common mental disorders" and their mostly pharmacological treatment are, in no small part, responsible for this situation. The cost that these disorders generate to the public health service is very high and they are usually associated with other issues like hyperfrequentation and side effects. However, research indicates that psychological treatment should be the first step when caring for these types of problems. We expect that the results show that extensive psychological therapy and combined treatment were the most effective. Nevertheless, brief psychological treatment is expected to be the most efficient in cost-benefit terms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Brief individual psychotherapy |
| Group 2 | Experimental | Other: Brief group psychotherapy |
| Group 3 | Experimental | Other: Combined intervention |
| Group 4 | Experimental | Other: Minimum psychological intervention |
| Group 5 | Active comparator | Other: Usual treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Emotional disorders
Key exclusion criteria (3 listed)
- Severe mental disorder
- Drug abuse
- Severe depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief individual psychotherapyIndividual 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, Farchione, Fairholme, Ellard, y Barlow, 2010). This intervention is provided by clinical psychologist in secondary care. | Other | Group 1 |
| Brief group psychotherapyGroup 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, Farchione, Fairholme, Ellard, y Barlow, 2010). This intervention is provided by clinical psychologist in primary care. | Other | Group 2 |
| Combined interventionTraditional psychotherapy and medication provided by a clinical psychologist and a psychiatrist in secondary care. | Other | Group 3 |
| Minimum psychological interventionPsychoeducation and bibliotherapy provided by a trained general practitioner in primary care. | Other | Group 4 |
| Usual treatmentMedication provided by a general practitioner. | Other | Group 5 |
Primary outcome
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.
The State-Trait Anxiety Inventory (STAI)
Time frame: 12 weeks
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, \& Jacobs, 1983). It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress AnxietyForm Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level. Internal consistency coefficients for the scale have ranged from .86 to .95; test-retest reliability coefficients have ranged from .65 to .75 over a 2-month interval (Spielberger et al., 1983).
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).
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.
The Patient Health Questionnaire (PHQ-15)
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-15 is the somatization module, which scores each DSM-IV criteria as "0" (not bothered at all) to "2" (bothered a lot).
The Patient Health Questionnaire (PHQ-PD)
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-PD is the panic disorder module, which scores each DSM-IV criteria as "yes" or "no".
Brief Symptom Inventory 18 (BSI-18)
Time frame: 12 weeks
The BSI-18 contains the three six-item scales somatization, depression, and anxiety as well as the Global Severity Index (GSI), including all 18 items. The BSI-18 is the latest and shortest of the multidimensional versions of the Symptom-Checklist 90-R.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 30671005Galvez-Lara M, Corpas J, Vencesla JF, Moriana JA. Evidence-Based Brief Psychological Treatment for Emotional Disorders in Primary and Specialized Care: Study Protocol of a Randomized Controlled Trial. Front Psychol. 2019 Jan 8;9:2674. doi: 10.3389/fpsyg.2018.02674. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Antonio Moriana E study director
Universidad de Cordoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief individual psychotherapy, Brief group psychotherapy and Combined intervention in people with Anxiety Disorders and Depression, run by Universidad de Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalised Anxiety Disorder Assessment (GAD-7) (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03286881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.