Affective DisorderNCT04489641
Brief Group Psychotherapy for Anxiety and Depression
A study testing Psychological treatment and Medication in people with Affective Disorder, 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 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Affective Disorder
- What is being tested?
- Psychological treatment and Medication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jan 2020to 16 Dec 2020
- 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
- Anxiety
- Depression
Who cannot join
- Severe mental disroders
- Drug abuse
- Suicidal ideation/severe depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Affective Disorder
- Being tested
- Psychological treatment, Medication
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological treatmentBehavioural
Psychological treatment
MedicationDrug
Pharmacological intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psychological treatment |
| Treatment as usual (TAU) | Active comparator | Medication provided by a general practitioner. Receives: Drug: Medication |
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 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)
It asseses somatoform symptoms. Scores could vary between 0-30 points.
Measured: 12 weeks
Patient Health Questionnaire-Panic Disorder (PHQ-PD)
It measures panic disorder symotmos. Scores vould vary between 0-15 points.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
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 posted28 Jul 2020
- Study start16 Jan 2020
- Primary completion16 Nov 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Affective DisorderStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Corpas López, Universidad de Córdoba
- Investigators
- Juan A. Moriana, Principal investigator, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489641
- Sponsor's protocol ID
- Interventional
- Status last verified
- Apr 2021
- First submitted
- 23 Jul 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Group Psychotherapy for Anxiety and Depression: A Randomized Controlled Trial of Efficacy and Mechanisms of Change
- ClinicalTrials.gov ID
- NCT04489641
- Acronym / sponsor ID
- Interventional
- Conditions
- Affective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad de CórdobaUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 28 Jul 2020 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief group psychotherapy | Experimental | Behavioral: Psychological treatmentGroup 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. |
| Treatment as usual (TAU) | Active comparator | Drug: MedicationMedication provided by a general practitioner. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Anxiety
- Depression
Key exclusion criteria (3 listed)
- Severe mental disroders
- Drug abuse
- Suicidal ideation/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 |
|---|---|---|
| Psychological treatmentPsychological treatment | Behavioural | Brief group psychotherapy |
| MedicationPharmacological intervention | Drug | Treatment as usual (TAU) |
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 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
It asseses somatoform symptoms. Scores could vary between 0-30 points.
Patient Health Questionnaire-Panic Disorder (PHQ-PD)
Time frame: 12 weeks
It measures panic disorder symotmos. Scores vould vary between 0-15 points.
4 secondary outcomes
Emotional Regulation Questionnaire (ERQ)
Time frame: 12 weeks
Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
Time frame: 12 weeks
Ruminative Response Scale-10 (RRS-10)
Time frame: 12 weeks
Metacognition Questionnaire-30 (MCQ-30)
Time frame: 12 weeks
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.
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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 A. Moriana principal investigator
Universidad de Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological treatment and Medication in people with Affective Disorder, 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 2 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 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.