DepressionNCT05235789
Cognitive Behavioral Therapy (REBT) Evaluation for Depression at Primary Care.
A study testing Rational-Emotive-Behavioral Therapy in people with Depression, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Background: Rational Emotional Behavioral Therapy (REBT) applied by the Primary Health Care (PC) Social Worker reduces psychotropic drug use and overcrowding at medical appointments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Rational-Emotive-Behavioral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2022to 1 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated at the primary care medical consultation , who signed the Informed Consent, with:
- first diagnosis of mild (F32.0)
- moderate major depression (F32.1, F32.9 (unspecified depression).
Who cannot join
- Participants diagnosed with severe depression F32.2, psychotic major depression F32.3, moderate recurrent depression F33.1, severe recurrent depression F33.2 or Beck test> 30 points at baseline visit
- Any other type of psychiatric pathology (F60.9 personality disorder, F20.9 schizophrenia, F42.9 obsessive compulsive disorder, F20.0 paranoid schizophrenia, F31.9 bipolar disorder, F43.10 post-traumatic stress disorder, obsessive compulsive disorder F42.9.
- Impaired cognitive ability according to PFEIFFER SPMSQ Scale (Short Portable Mental State Questionnaire) (<3 points)
- Dementia - presenile dementia - senile dementia (F03.90). All three share code, dementia Sclerotic artery - vascular dementia - multiinfarct dementia (F01.50). All three share code. Alzheimer's disease (G30) and Lewy body dementia (G31.89)
- Person included in home care (Z74.9)
- The unwillingness to treat.
Show all 11Show fewer
- Participation in psychoeducational groups of the Catalan Institute of Health ("Institut Català de la Salut" -ICS-), or other individual or group psychological therapies.
- Any pathology or circumstance that makes it impossible for the user to participate in the study and / or the follow-up required by the same:
- Terminal illnesses, (life expectancy of less than one year according to ECAP); Advanced Chronic Diseases (MACA in the section on chronicity in the ECAP)
- Illiteracy and / or language barrier
- Deaths and transfers from the generation of the recruitment list from the beginning of the study
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Catalan Health Institute. ABS Sant Andreu 9D
Barcelona, 08030
Carme Rovira Aler, LCSW, crovira.bcn.ics@gencat.cat
Carme Rovira Aler, LCSW
About this study
Official title: Evaluation of Individual Intervention With Rational Emotional Behavioral Therapy Performed by Primary Care Clinical Social Workers in People With a New Episode of Depression: a Randomized Clinical Trial
Background: Rational Emotional Behavioral Therapy (REBT) applied by the Primary Health Care (PC) Social Worker reduces psychotropic drug use and overcrowding at medical appointments.
Hypothesis: The REBT in people diagnosed with mild-moderate depression in the social work consultation of PC, improves the clinical control of this disorder, with lower consumption of health resources, better quality of life and user satisfaction, with respect to the usual clinical practice, in addition to being cost-effective.
Read more
Goals: To compare the effectiveness, cost-effectiveness and cost-utility of REBT as an intervention tool with respect to the usual clinical practice in adults with a diagnosis of mild-moderate major depression in PC.
Methodology: Randomized clinical trial with control group, in people diagnosed with major depression attached to the PC. This study is carried out in 9 primary care centers in Catalonia.
Determinations: Participants are measured at the beginning of the study, end of the intervention and at 1 year of the beginning: Control of symptoms using PHQ-9; Health-related quality of life using the EQ-5D-5L scale; Self-perceived well-being, using the Ryff Psychological Well-Being Scale; Pharmacological prescription and withdrawal of anxiolytics, hypnotics and antidepressants; Frequency of PC consultations; Assignable costs through TIC-P; Functional social support perceived prior to the intervention using the Duke questionnaire; and user satisfaction with the treatment at the end of the intervention using CRES-4.
The exposure variable is the assignment to the REBT psychosocial intervention group or the usual clinical practice control group.
Statistical analysis: Description of the items of the measuring instruments used per month will calculate the cost by variation of quality-adjusted life year (QALY) and the increase of associated cost-effectiveness ratio contrasting the hypothesis that this is different to 22000 € by means of t-test.
Expected results: REBT in people diagnosed with mild-moderate depression in the social work consultation of PC, will improve in the clinical control of this disorder, a lower consumption of health resources, improvement in the Quality of Life and in the user satisfaction. Therefore, REBT is effective, and cost-effective in managing people diagnosed with mild-moderate major depression.
Applicability and Relevance: REBT will help people to acquire tools to deal with difficulties in daily life and provide economic savings in health care costs.
- Conditions
- Depression
- Being tested
- Rational-Emotive-Behavioral Therapy, Control Group usual care
- Keywords
- Effectiveness, cost effectiveness, rational behavioral emotional therapy, depression, clinical trial
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rational-Emotive-Behavioral TherapyOther
Also called Cognitive-Emotive-Behavioral Therapy, REBT, CBT, REBT-CBT
The structure of the REBT sessions includes the following points:
- Determine specific goals that explain what the participant want to achieve through the content of the session.
- Explain the level of skills to be achieved in each session.
- Development of the session, reminder of the previous session, review of homework (from the second session to the 8th). Irrational beliefs and disruptive thoughts will be worked on together with the participant in order to achieve an improvement in their emotional state. Key messages with healthier alternatives that make your daily life easier.
- Establishing homework. Using the REBT Toolbox with Key Messages.
- Individual psychosocial work will be recorded in the computerized medical history.
Control Group usual careOther
Also called conventional treatment, usual care
In the control group, for each center , the depression is treated as usual with the conventional treatment, according to national and international guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The social workers in each center of primary care held eight 30 minutes sessions fortnightly of Rational-Emotive-Behavioral Therapy. First session is informative about the type of treatment to be performed. The next sessions work events, thoughts and feelings with the goal of changing the dysfunctional thoughts by other more rational ones, measured by scales. Receives: Other: Rational-Emotive-Behavioral Therapy |
| Control group | Active comparator | The control group (GC) in each center of primary care will take the usual medical care for depression, according with up-dated national and international guidelines. Receives: Other: Control Group usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
The PHQ-9 questionnaire consists of 9 items that assess the presence of depressive symptoms (corresponding to Diagnostic and Statistical Manual of Mental Disorders -DSM-IV-) in the last 2 weeks, according to frequency: 0 = "never", 1 = "some days", 2 = "more than half the days "and 3 =" almost every day "; allows a classification in "Major Depressive Syndrome", "Other Depressive Syndromes", "Positive Depressive Symptoms" or "Negative Depressive Symptoms". However, in the present study we will use the total score (unweighted summation of item scores) as a measure of depressive symptoms.
Measured: It will be measured as baseline.
Patient Health Questionnaire (PHQ-9)
The PHQ-9 questionnaire consists of 9 items that assess the presence of depressive symptoms (corresponding to Diagnostic and Statistical Manual of Mental Disorders -DSM-IV-) in the last 2 weeks, according to frequency: 0 = "never", 1 = "some days", 2 = "more than half the days "and 3 =" almost every day "; allows a classification in "Major Depressive Syndrome", "Other Depressive Syndromes", "Positive Depressive Symptoms" or "Negative Depressive Symptoms". However, in the present study we will use the total score (unweighted summation of item scores) as a measure of depressive symptoms.
Measured: It will be measured at 4 months from baseline.
Patient Health Questionnaire (PHQ-9)
The PHQ-9 questionnaire consists of 9 items that assess the presence of depressive symptoms (corresponding to Diagnostic and Statistical Manual of Mental Disorders -DSM-IV-) in the last 2 weeks, according to frequency: 0 = "never", 1 = "some days", 2 = "more than half the days "and 3 =" almost every day "; allows a classification in "Major Depressive Syndrome", "Other Depressive Syndromes", "Positive Depressive Symptoms" or "Negative Depressive Symptoms". However, in the present study we will use the total score (unweighted summation of item scores) as a measure of depressive symptoms.
Measured: It will be measured at 1 year from baseline.
5-Dimensional, 5-Level EuroQol Questionnaire (EQ-5D-5L)
The EuroQol 5D5L questionnaire contains an Analog Visual Scale, and 5 items / dimensions (mobility, personal care, daily activities, pain / discomfort and anxiety / depression), rated at 5 levels ("No problems", "mild problems", "moderate problems", "severe problems" and "extreme problems or incapable of") . The final profit index will be calculated using the standardized hybrid method (compound time equivalence / discrete choice experiments) of Spanish social preferences.
Measured: It will be measured as baseline.
5-Dimensional, 5-Level EuroQol Questionnaire (EQ-5D-5L)
The EuroQol 5D5L questionnaire contains an Analog Visual Scale, and 5 items / dimensions (mobility, personal care, daily activities, pain / discomfort and anxiety / depression), rated at 5 levels ("No problems", "mild problems", "moderate problems", "severe problems" and "extreme problems or incapable of") . The final profit index will be calculated using the standardized hybrid method (compound time equivalence / discrete choice experiments) of Spanish social preferences.
Measured: It will be measured at 4 months from baseline.
5-Dimensional, 5-Level EuroQol Questionnaire (EQ-5D-5L)
The EuroQol 5D5L questionnaire contains an Analog Visual Scale, and 5 items / dimensions (mobility, personal care, daily activities, pain / discomfort and anxiety / depression), rated at 5 levels ("No problems", "mild problems", "moderate problems", "severe problems" and "extreme problems or incapable of") . The final profit index will be calculated using the standardized hybrid method (compound time equivalence / discrete choice experiments) of Spanish social preferences.
Measured: It will be measured at 1 year from baseline.
Scale of Psychological Well-Being (Ryff, 1989).
Reduced self-perceived well-being questionnaire of 29 items, subdivided into 6 dimensions with statements about Self-Acceptance, Positive Relationships, Autonomy, Mastery of the Environment, Personal Growth and Purpose in Life. It uses a 6-point likert scale where 1 strongly agrees and 6 strongly disagrees. The final results will be by dimensions.
Measured: It will be measured as baseline.
Scale of Psychological Well-Being (Ryff, 1989).
Reduced self-perceived well-being questionnaire of 29 items, subdivided into 6 dimensions with statements about Self-Acceptance, Positive Relationships, Autonomy, Mastery of the Environment, Personal Growth and Purpose in Life. It uses a 6-point likert scale where 1 strongly agrees and 6 strongly disagrees. The final results will be by dimensions.
Measured: It will be measured at 4 months from baseline.
Scale of Psychological Well-Being (Ryff, 1989).
Reduced self-perceived well-being questionnaire of 29 items, subdivided into 6 dimensions with statements about Self-Acceptance, Positive Relationships, Autonomy, Mastery of the Environment, Personal Growth and Purpose in Life. It uses a 6-point likert scale where 1 strongly agrees and 6 strongly disagrees. The final results will be by dimensions.
Measured: It will be measured at 1 year from baseline.
Treatment Inventory Cost in Psychiatric patients (TIC-P)
The TIC-P questionnaire includes 8 general questions, costs in two dimensions: use of health resources (direct costs, 35 questions) and loss of productivity (indirect costs, Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire -iPCQ-, 12 questions).
Measured: It will be measured as baseline.
Treatment Inventory Cost in Psychiatric patients (TIC-P)
The TIC-P questionnaire includes 8 general questions, costs in two dimensions: use of health resources (direct costs, 35 questions) and loss of productivity (indirect costs, Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire -iPCQ-, 12 questions).
Measured: It will be measured at 4 months from baseline.
Treatment Inventory Cost in Psychiatric patients (TIC-P)
The TIC-P questionnaire includes 8 general questions, costs in two dimensions: use of health resources (direct costs, 35 questions) and loss of productivity (indirect costs, Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire -iPCQ-, 12 questions).
Measured: It will be measured at 1 year from baseline.
Attendance of primary care during the previous year.
Number of scheduled PC visits (both face-to-face and telephone) for physician / social worker / nurse, in the year prior to the start of the study, and at the end of follow-up.
Measured: It will be measured as baseline.
Attendance of primary care during the previous year.
Number of scheduled PC visits (both face-to-face and telephone) for physician / social worker / nurse, in the year prior to the start of the study, and at the end of follow-up.
Measured: It will be measured at baseline.
Attendance of primary care during the previous year.
Number of scheduled PC visits (both face-to-face and telephone) for physician / social worker / nurse, in the year prior to the start of the study, and at the end of follow-up.
Measured: It will be measured at 1 year from baseline.
Duke Functional Social Support Questionnaire.
The Duke Functional Social Support Questionnaire consists of 11 Likert-type items from 1 ("much less than I want") to 5 ("as much as I want"). It measures perceived social support and has two dimensions: "confidential social support" and "affective social support".
Measured: It will be measured at 4 months from baseline.
Satisfaction Scale with the treatment received (CRES-4).
The CRES-4 scale measures 4 items likert: satisfaction with treatment (rated 0-5; "completely dissatisfied" and "completely satisfied, respectively), degree of resolution (0-5), previous emotional state (0-4), current emotional state (0-4). Three dimensions are derived from 0 (worst rating) to 100 (best rating): satisfaction, problem solving, and perception of emotional change.
Measured: It will be measured at 4 months from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start10 Jan 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Model description
- Randomized clinical trial with control group, in people diagnosed with major depression attached to the PC. This study is carried out in 9 primary care centers in Catalonia.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut
- Responsible party
- Sponsor
- Investigators
- Carme Rovira Aler, LCSW, Principal investigator, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235789
- Sponsor's protocol ID
- 21/152-P
- Status last verified
- Mar 2023
- First submitted
- 13 Dec 2021
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Individual Intervention With Rational Emotional Behavioral Therapy Performed by Primary Care Clinical Social Workers in People With a New Episode of Depression: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05235789
- Acronym / sponsor ID
- 21/152-P
- Conditions
- Depression
- Keywords
- Effectiveness, cost effectiveness, rational behavioral emotional therapy, depression, clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Català de la Salut
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 11 Feb 2022 (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.
Background: Rational Emotional Behavioral Therapy (REBT) applied by the Primary Health Care (PC) Social Worker reduces psychotropic drug use and overcrowding at medical appointments.
Hypothesis: The REBT in people diagnosed with mild-moderate depression in the social work consultation of PC, improves the clinical control of this disorder, with lower consumption of health resources, better quality of life and user satisfaction, with respect to the usual clinical practice, in addition to being cost-effective.
Goals: To compare the effectiveness, cost-effectiveness and cost-utility of REBT as an intervention tool with respect to the usual clinical practice in adults with a diagnosis of mild-moderate major depression in PC.
Methodology: Randomized clinical trial with control group, in people diagnosed with major depression attached to the PC. This study is carried out in 9 primary care centers in Catalonia.
Determinations: Participants are measured at the beginning of the study, end of the intervention and at 1 year of the beginning: Control of symptoms using PHQ-9; Health-related quality of life using the EQ-5D-5L scale; Self-perceived well-being, using the Ryff Psychological Well-Being Scale; Pharmacological prescription and withdrawal of anxiolytics, hypnotics and antidepressants; Frequency of PC consultations; Assignable costs through TIC-P; Functional social support perceived prior to the intervention using the Duke questionnaire; and user satisfaction with the treatment at the end of the intervention using CRES-4.
The exposure variable is the assignment to the REBT psychosocial intervention group or the usual clinical practice control group.
Statistical analysis: Description of the items of the measuring instruments used per month will calculate the cost by variation of quality-adjusted life year (QALY) and the increase of associated cost-effectiveness ratio contrasting the hypothesis that this is different to 22000 € by means of t-test.
Expected results: REBT in people diagnosed with mild-moderate depression in the social work consultation of PC, will improve in the clinical control of this disorder, a lower consumption of health resources, improvement in the Quality of Life and in the user satisfaction. Therefore, REBT is effective, and cost-effective in managing people diagnosed with mild-moderate major depression.
Applicability and Relevance: REBT will help people to acquire tools to deal with difficulties in daily life and provide economic savings in health care costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial with control group, in people diagnosed with major depression attached to the PC. This study is carried out in 9 primary care centers in Catalonia.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Rational-Emotive-Behavioral TherapyThe social workers in each center of primary care held eight 30 minutes sessions fortnightly of Rational-Emotive-Behavioral Therapy. First session is informative about the type of treatment to be performed. The next sessions work events, thoughts and feelings with the goal of changing the dysfunctional thoughts by other more rational ones, measured by scales. |
| Control group | Active comparator | Other: Control Group usual careThe control group (GC) in each center of primary care will take the usual medical care for depression, according with up-dated national and international guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients treated at the primary care medical consultation , who signed the Informed Consent, with:
- first diagnosis of mild (F32.0)
- moderate major depression (F32.1, F32.9 (unspecified depression).
Key exclusion criteria (11 listed)
- Participants diagnosed with severe depression F32.2, psychotic major depression F32.3, moderate recurrent depression F33.1, severe recurrent depression F33.2 or Beck test> 30 points at baseline visit
- Any other type of psychiatric pathology (F60.9 personality disorder, F20.9 schizophrenia, F42.9 obsessive compulsive disorder, F20.0 paranoid schizophrenia, F31.9 bipolar disorder, F43.10 post-traumatic stress disorder, obsessive compulsive disorder F42.9.
- Impaired cognitive ability according to PFEIFFER SPMSQ Scale (Short Portable Mental State Questionnaire) (<3 points)
- Dementia - presenile dementia - senile dementia (F03.90). All three share code, dementia Sclerotic artery - vascular dementia - multiinfarct dementia (F01.50). All three share code. Alzheimer's disease (G30) and Lewy body dementia (G31.89)
- Person included in home care (Z74.9)
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 |
|---|---|---|
| Rational-Emotive-Behavioral TherapyAlso: Cognitive-Emotive-Behavioral Therapy, REBT, CBT, REBT-CBTThe structure of the REBT sessions includes the following points: 1. Determine specific goals that explain what the participant want to achieve through the content of the session. 2. Explain the level of skills to be achieved in each session. 3. Development of the session, reminder of the previous session, review of homework (from the second session to the 8th). Irrational beliefs and disruptive thoughts will be worked on together with the participant in order to achieve an improvement in their emotional state. Key messages with healthier alternatives that make your daily life easier. 4. Establishing homework. Using the REBT Toolbox with Key Messages. 5. Individual psychosocial work will be recorded in the computerized medical history. | Other | Intervention group |
| Control Group usual careAlso: conventional treatment, usual careIn the control group, for each center , the depression is treated as usual with the conventional treatment, according to national and international guidelines. | Other | Control group |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: It will be measured as baseline.
The PHQ-9 questionnaire consists of 9 items that assess the presence of depressive symptoms (corresponding to Diagnostic and Statistical Manual of Mental Disorders -DSM-IV-) in the last 2 weeks, according to frequency: 0 = "never", 1 = "some days", 2 = "more than half the days "and 3 =" almost every day "; allows a classification in "Major Depressive Syndrome", "Other Depressive Syndromes", "Positive Depressive Symptoms" or "Negative Depressive Symptoms". However, in the present study we will use the total score (unweighted summation of item scores) as a measure of depressive symptoms.
Patient Health Questionnaire (PHQ-9)
Time frame: It will be measured at 4 months from baseline.
The PHQ-9 questionnaire consists of 9 items that assess the presence of depressive symptoms (corresponding to Diagnostic and Statistical Manual of Mental Disorders -DSM-IV-) in the last 2 weeks, according to frequency: 0 = "never", 1 = "some days", 2 = "more than half the days "and 3 =" almost every day "; allows a classification in "Major Depressive Syndrome", "Other Depressive Syndromes", "Positive Depressive Symptoms" or "Negative Depressive Symptoms". However, in the present study we will use the total score (unweighted summation of item scores) as a measure of depressive symptoms.
Patient Health Questionnaire (PHQ-9)
Time frame: It will be measured at 1 year from baseline.
The PHQ-9 questionnaire consists of 9 items that assess the presence of depressive symptoms (corresponding to Diagnostic and Statistical Manual of Mental Disorders -DSM-IV-) in the last 2 weeks, according to frequency: 0 = "never", 1 = "some days", 2 = "more than half the days "and 3 =" almost every day "; allows a classification in "Major Depressive Syndrome", "Other Depressive Syndromes", "Positive Depressive Symptoms" or "Negative Depressive Symptoms". However, in the present study we will use the total score (unweighted summation of item scores) as a measure of depressive symptoms.
5-Dimensional, 5-Level EuroQol Questionnaire (EQ-5D-5L)
Time frame: It will be measured as baseline.
The EuroQol 5D5L questionnaire contains an Analog Visual Scale, and 5 items / dimensions (mobility, personal care, daily activities, pain / discomfort and anxiety / depression), rated at 5 levels ("No problems", "mild problems", "moderate problems", "severe problems" and "extreme problems or incapable of") . The final profit index will be calculated using the standardized hybrid method (compound time equivalence / discrete choice experiments) of Spanish social preferences.
5-Dimensional, 5-Level EuroQol Questionnaire (EQ-5D-5L)
Time frame: It will be measured at 4 months from baseline.
The EuroQol 5D5L questionnaire contains an Analog Visual Scale, and 5 items / dimensions (mobility, personal care, daily activities, pain / discomfort and anxiety / depression), rated at 5 levels ("No problems", "mild problems", "moderate problems", "severe problems" and "extreme problems or incapable of") . The final profit index will be calculated using the standardized hybrid method (compound time equivalence / discrete choice experiments) of Spanish social preferences.
5-Dimensional, 5-Level EuroQol Questionnaire (EQ-5D-5L)
Time frame: It will be measured at 1 year from baseline.
The EuroQol 5D5L questionnaire contains an Analog Visual Scale, and 5 items / dimensions (mobility, personal care, daily activities, pain / discomfort and anxiety / depression), rated at 5 levels ("No problems", "mild problems", "moderate problems", "severe problems" and "extreme problems or incapable of") . The final profit index will be calculated using the standardized hybrid method (compound time equivalence / discrete choice experiments) of Spanish social preferences.
Scale of Psychological Well-Being (Ryff, 1989).
Time frame: It will be measured as baseline.
Reduced self-perceived well-being questionnaire of 29 items, subdivided into 6 dimensions with statements about Self-Acceptance, Positive Relationships, Autonomy, Mastery of the Environment, Personal Growth and Purpose in Life. It uses a 6-point likert scale where 1 strongly agrees and 6 strongly disagrees. The final results will be by dimensions.
Scale of Psychological Well-Being (Ryff, 1989).
Time frame: It will be measured at 4 months from baseline.
Reduced self-perceived well-being questionnaire of 29 items, subdivided into 6 dimensions with statements about Self-Acceptance, Positive Relationships, Autonomy, Mastery of the Environment, Personal Growth and Purpose in Life. It uses a 6-point likert scale where 1 strongly agrees and 6 strongly disagrees. The final results will be by dimensions.
Scale of Psychological Well-Being (Ryff, 1989).
Time frame: It will be measured at 1 year from baseline.
Reduced self-perceived well-being questionnaire of 29 items, subdivided into 6 dimensions with statements about Self-Acceptance, Positive Relationships, Autonomy, Mastery of the Environment, Personal Growth and Purpose in Life. It uses a 6-point likert scale where 1 strongly agrees and 6 strongly disagrees. The final results will be by dimensions.
Treatment Inventory Cost in Psychiatric patients (TIC-P)
Time frame: It will be measured as baseline.
The TIC-P questionnaire includes 8 general questions, costs in two dimensions: use of health resources (direct costs, 35 questions) and loss of productivity (indirect costs, Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire -iPCQ-, 12 questions).
Treatment Inventory Cost in Psychiatric patients (TIC-P)
Time frame: It will be measured at 4 months from baseline.
The TIC-P questionnaire includes 8 general questions, costs in two dimensions: use of health resources (direct costs, 35 questions) and loss of productivity (indirect costs, Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire -iPCQ-, 12 questions).
Treatment Inventory Cost in Psychiatric patients (TIC-P)
Time frame: It will be measured at 1 year from baseline.
The TIC-P questionnaire includes 8 general questions, costs in two dimensions: use of health resources (direct costs, 35 questions) and loss of productivity (indirect costs, Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire -iPCQ-, 12 questions).
Attendance of primary care during the previous year.
Time frame: It will be measured as baseline.
Number of scheduled PC visits (both face-to-face and telephone) for physician / social worker / nurse, in the year prior to the start of the study, and at the end of follow-up.
Attendance of primary care during the previous year.
Time frame: It will be measured at baseline.
Number of scheduled PC visits (both face-to-face and telephone) for physician / social worker / nurse, in the year prior to the start of the study, and at the end of follow-up.
Attendance of primary care during the previous year.
Time frame: It will be measured at 1 year from baseline.
Number of scheduled PC visits (both face-to-face and telephone) for physician / social worker / nurse, in the year prior to the start of the study, and at the end of follow-up.
Duke Functional Social Support Questionnaire.
Time frame: It will be measured at 4 months from baseline.
The Duke Functional Social Support Questionnaire consists of 11 Likert-type items from 1 ("much less than I want") to 5 ("as much as I want"). It measures perceived social support and has two dimensions: "confidential social support" and "affective social support".
Satisfaction Scale with the treatment received (CRES-4).
Time frame: It will be measured at 4 months from baseline.
The CRES-4 scale measures 4 items likert: satisfaction with treatment (rated 0-5; "completely dissatisfied" and "completely satisfied, respectively), degree of resolution (0-5), previous emotional state (0-4), current emotional state (0-4). Three dimensions are derived from 0 (worst rating) to 100 (best rating): satisfaction, problem solving, and perception of emotional change.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
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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.
Carme Rovira Aler, LCSW principal investigator
Catalan Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rational-Emotive-Behavioral Therapy in people with Depression, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carme Rovira Aler, LCSW (932745490 ext. 365, crovira.bcn.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: It will be measured as baseline.). The study lists 17 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 20 Mar 2023.