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

Status Recruiting

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

• NCT number: NCT05235789
• Study type: Interventional
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: Carme Rovira Aler, LCSW
• Phone: 932745490
• Email: crovira.bcn.ics@gencat.cat
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Completion date: January 1, 2025