NCT05235789

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

Status unknown NA Last updated 20 March 2023

What this trial tests

NA trial testing Rational-Emotive-Behavioral Therapy in Depression in 900 participants. Status unknown.

Timeline

10 January 2022

Primary endpoint
1 August 2023

1 January 2025

Quick facts

Lead sponsor	Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	900
Start date	10 January 2022
Primary completion	1 August 2023
Estimated completion	1 January 2025
Sites	1 location across Spain

Drugs / interventions tested

• Rational-Emotive-Behavioral Therapy
• Control Group usual care

Conditions studied

• Depression — all drugs for Depression →

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina — full company profile →

Who can join

18 and older, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.