Clinical trial NCT03243799: Effectiveness of a Psychoeducational Group Intervention in Patients With Depression and Physical Comorbidity
Official title: Effectiveness of a Psychoeducational Group Intervention Conducted by Primary Health Care Nurses in Patients With Depression and Physical Comorbidity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2017-08-09
Enrollment: 504
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in rate of remission of depression
timeFrame: At 12 months of follow-up
Secondary outcomes:
measure: Changes in rate of remission of depression
timeFrame: At 3 months of follow-up
measure: Changes in the control of DM2
timeFrame: At 12 months of follow-up
measure: Changes in the control of COPD
timeFrame: At 12 months of follow-up
measure: Changes in the control of asthma
timeFrame: At 12 months of follow-up
measure: Changes in the control of Ischemic heart disease
timeFrame: At 12 months of follow-up
measure: Referrals to mental health
timeFrame: At 12 months of follow-up
measure: Record of therapeutic compliance
timeFrame: At 12 months of follow-up
measure: Changes in the quality of life
timeFrame: At 12 months of follow-up
measure: Quantification of the use of services
timeFrame: At 12 months of follow-up
measure: Satisfaction with the intervention
timeFrame: At 3 months of follow-up
measure: Adherence to the intervention
timeFrame: At 3 months of follow-up
measure: Qualitative changes of the state of mind at the end of the intervention
timeFrame: At 3 and 12 months of follow-up
measure: Qualitative changes of the state of health at the end of the intervention
timeFrame: At 3 and 12 months of follow-up
Other outcomes:
Locations:
city: Santa Margarida de Montbui
country: Spain
facility: Centre d'Atenció Primària (CAP) Santa Margarida de Montbui
state: Barcelona
Study officials:
References:
citation: Casanas R, Martin Royo J, Fernandez-San-Martin MI, Raya Tena A, Mendioroz J, Sauch Valmana G, Masa-Font R, Casajuana-Closas M, Fernandez Linares EM, Cols-Sagarra C, Gonzalez Tejon S, Foguet-Boreu Q, Martin Lopez LM. Effectiveness of a psychoeducation group intervention conducted by primary healthcare nurses in patients with depression and physical comorbidity: study protocol for a randomized, controlled trial. BMC Health Serv Res. 2019 Jun 26;19(1):427. doi: 10.1186/s12913-019-4198-7.