Effectiveness of a Psychoeducational Group Intervention in Patients With Depression and Physical Comorbidity

Depressive Disorder Clinical Trial

— PsiCoDep  

Official title:

Effectiveness of a Psychoeducational Group Intervention Conducted by Primary Health Care Nurses in Patients With Depression and Physical Comorbidity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03243799
• Other study ID #: PI16/01272
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: December 2019

Study information

• Verified date: May 2019
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim is to evaluate the effectiveness of an intervention based on a psychoeducational program carried out by primary care nurses, to improve the rate of remission and response of depression in patients with physical chronic illness (diabetes, COPD, asthma and / or ischemic heart disease). Secondarily, to assess the cost-effectiveness of the intervention, the effectiveness to improve the control of physical pathology, the impact on quality of life and the feasibility of the intervention.

Methods: a multicentre, randomized clinical trial, with two groups and 1 year follow-up evaluation. Economic evaluation study. We will study 504 patients (252 in each group), over 50 years assigned to 25 primary care teams (PC) from Catalonia (urban, semi-urban and rural) with major depression and with at least one of the diseases: diabetes mellitus type 2, chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease. They will be distributed randomly into two groups. The intervention group will participate in psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from PC, consisting of health education on chronic physical illness and depressive symptoms.

Main measurements: clinical remission of depression and / or response to intervention (Beck depression inventory: BDI-II). Secondary measures: improvement in control of chronic disease (blood test and physical parameters), drug compliance (test Morinsky-Green and number of packaging), quality of life (EQ-5D), medical service utilization (appointments and hospital admissions due to complications) and feasibility of the intervention (satisfaction and compliance). Evaluations will be masked and conducted at 0, 3 and 12 months. At 6 months, patients will receive a call from nurses.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 504
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Presence of at least one of the following diseases: type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease.

• Meet major depression criteria at the time of the study: Score above 13 on the BDI-II scale.

• Possibility of follow-up of one year by the same primary care team.

• At least read and write Spanish or Catalan.

Exclusion Criteria:

• Diagnosis of dementia or moderate or high cognitive impairment (5 or more errors according to the pfeiffer scale).

• Major depression with psychotic symptoms or with other serious psychiatric comorbidities.

• Moderate or high risk of suicide (6 or more points on the MINI suicide scale).

• Dependency disorders due to alcohol or other drug abuse.

• Advanced stage physical disease.

• Inability to travel to the center.

• Be receiving some psychological therapy by the Center of mental health (CSM) of reference

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Group psychoeducation
Educational group sessions for patients with depression and physical comorbidities in order to improve the degree of control of their illnesses

Locations

Country	Name	City	State
Spain	Centre d'Atenció Primària (CAP) Santa Margarida de Montbui	Santa Margarida de Montbui	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in rate of remission of depression	Changes in the score of the BDI-II scale	At 12 months of follow-up
Secondary	Changes in rate of remission of depression	Changes in the score of the BDI-II scale	At 3 months of follow-up
Secondary	Changes in the control of DM2	Changes in HbA1c	At 12 months of follow-up
Secondary	Changes in the control of COPD	Changes in FEV1	At 12 months of follow-up
Secondary	Changes in the control of asthma	Changes in FEV1	At 12 months of follow-up
Secondary	Changes in the control of Ischemic heart disease	Changes in LDL cholesterol	At 12 months of follow-up
Secondary	Referrals to mental health	Number of visits to mental health centers	At 12 months of follow-up
Secondary	Record of therapeutic compliance	Morisky-Green test	At 12 months of follow-up
Secondary	Changes in the quality of life	Measured by the EuroQol scale (EQ-5D)	At 12 months of follow-up
Secondary	Quantification of the use of services	Number of hospital admissions	At 12 months of follow-up
Secondary	Satisfaction with the intervention	Survey at the end of the intervention	At 3 months of follow-up
Secondary	Adherence to the intervention	Number of assisted sessions	At 3 months of follow-up
Secondary	Qualitative changes of the state of mind at the end of the intervention	better, equal or worse	At 3 and 12 months of follow-up
Secondary	Qualitative changes of the state of health at the end of the intervention	better, equal or worse	At 3 and 12 months of follow-up