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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2025
  • participants needed
    900
  • sponsor
    Jordi Gol i Gurina Foundation
Updated on 24 March 2022
behavior therapy
antidepressants
depressed mood
moderate depression

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.

Details
Condition Depression
Treatment Control Group Usual Care, Rational-Emotive-Behavioral Therapy
Clinical Study IdentifierNCT05235789
SponsorJordi Gol i Gurina Foundation
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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>
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
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