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

NCT ID: NCT05235789

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2025-01-01

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

The social workers in each center of primary care held eight 30 minutes sessions fortnightly of Rational-Emotive-Behavioral Therapy. First session is informative about the type of treatment to be performed. The next sessions work events, thoughts and feelings with the goal of changing the dysfunctional thoughts by other more rational ones, measured by scales.

Group Type: EXPERIMENTAL

Rational-Emotive-Behavioral Therapy

Intervention Type: OTHER

The structure of the REBT sessions includes the following points:

1. Determine specific goals that explain what the participant want to achieve through the content of the session.

2. Explain the level of skills to be achieved in each session.

3. 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.

4. Establishing homework. Using the REBT Toolbox with Key Messages.

5. Individual psychosocial work will be recorded in the computerized medical history.

Control group

The control group (GC) in each center of primary care will take the usual medical care for depression, according with up-dated national and international guidelines.

Group Type: ACTIVE_COMPARATOR

Control Group usual care

Intervention Type: OTHER

In the control group, for each center , the depression is treated as usual with the conventional treatment, according to national and international guidelines.

Interventions

Rational-Emotive-Behavioral Therapy

The structure of the REBT sessions includes the following points:

1. Determine specific goals that explain what the participant want to achieve through the content of the session.

2. Explain the level of skills to be achieved in each session.

3. 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.

4. Establishing homework. Using the REBT Toolbox with Key Messages.

5. Individual psychosocial work will be recorded in the computerized medical history.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Cognitive-Emotive-Behavioral Therapy; REBT; CBT; REBT-CBT; conventional treatment; usual care

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Català de la Salut

OTHER

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carme Rovira Aler, LCSW

Role: PRINCIPAL_INVESTIGATOR

Catalan Institute of Health

Locations

Catalan Health Institute. ABS Sant Andreu 9D

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Carme Rovira Aler, LCSW

Role: CONTACT

crovira.bcn.ics@gencat.cat

932745490 ext. 365

Facility Contacts

Carme Rovira Aler, LCSW

Role: primary

crovira.bcn.ics@gencat.cat

Other Identifiers

21/152-P

Identifier Type: -

Identifier Source: org_study_id