Cognitive Behavioral Therapy (REBT) Evaluation for Depression at Primary Care.

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235789
• Other study ID #: 21/152-P
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2023
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: Carme Rovira Aler, LCSW
• Phone: 932745490
• Email: crovira.bcn.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: January 1, 2025
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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).

Exclusion Criteria:

• 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.

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Rational-Emotive-Behavioral Therapy
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 care
In the control group, for each center , the depression is treated as usual with the conventional treatment, according to national and international guidelines.

Locations

Country	Name	City	State
Spain	Catalan Health Institute. ABS Sant Andreu 9D	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina	Institut Català de la Salut

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	It will be measured as baseline.
Primary	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.	It will be measured at 4 months from baseline.
Primary	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.	It will be measured at 1 year from baseline.
Primary	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.	It will be measured as baseline.
Primary	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.	It will be measured at 4 months from baseline.
Primary	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.	It will be measured at 1 year from baseline.
Primary	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.	It will be measured as baseline.
Primary	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.	It will be measured at 4 months from baseline.
Primary	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.	It will be measured at 1 year from baseline.
Primary	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).	It will be measured as baseline.
Primary	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).	It will be measured at 4 months from baseline.
Primary	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).	It will be measured at 1 year from baseline.
Primary	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.	It will be measured as baseline.
Primary	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.	It will be measured at baseline.
Primary	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.	It will be measured at 1 year from baseline.
Primary	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".	It will be measured at 4 months from baseline.
Primary	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.	It will be measured at 4 months from baseline.