Clinical trial NCT05235789: Cognitive Behavioral Therapy (REBT) Evaluation for Depression at Primary Care.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Effectiveness
cost effectiveness
rational behavioral emotional therapy
depression
clinical trial
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
First posted: 2022-02-11
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: It will be measured as baseline.
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: It will be measured at 4 months from baseline.
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: It will be measured at 1 year from baseline.
measure: 5-Dimensional, 5-Level EuroQol Questionnaire (EQ-5D-5L)
timeFrame: It will be measured as baseline.
measure: 5-Dimensional, 5-Level EuroQol Questionnaire (EQ-5D-5L)
timeFrame: It will be measured at 4 months from baseline.
measure: 5-Dimensional, 5-Level EuroQol Questionnaire (EQ-5D-5L)
timeFrame: It will be measured at 1 year from baseline.
measure: Scale of Psychological Well-Being (Ryff, 1989).
timeFrame: It will be measured as baseline.
measure: Scale of Psychological Well-Being (Ryff, 1989).
timeFrame: It will be measured at 4 months from baseline.
measure: Scale of Psychological Well-Being (Ryff, 1989).
timeFrame: It will be measured at 1 year from baseline.
measure: Treatment Inventory Cost in Psychiatric patients (TIC-P)
timeFrame: It will be measured as baseline.
measure: Treatment Inventory Cost in Psychiatric patients (TIC-P)
timeFrame: It will be measured at 4 months from baseline.
measure: Treatment Inventory Cost in Psychiatric patients (TIC-P)
timeFrame: It will be measured at 1 year from baseline.
measure: Attendance of primary care during the previous year.
timeFrame: It will be measured as baseline.
measure: Attendance of primary care during the previous year.
timeFrame: It will be measured at baseline.
measure: Attendance of primary care during the previous year.
timeFrame: It will be measured at 1 year from baseline.
measure: Duke Functional Social Support Questionnaire.
timeFrame: It will be measured at 4 months from baseline.
measure: Satisfaction Scale with the treatment received (CRES-4).
timeFrame: It will be measured at 4 months from baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Catalan Health Institute. ABS Sant Andreu 9D
Study officials:
affiliation: Catalan Institute of Health
name: Carme Rovira Aler, LCSW
role: PRINCIPAL_INVESTIGATOR
References: