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

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

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.

Study Overview

• Status: Unknown
• Conditions: Depressive Disorder
• Intervention / Treatment: Behavioral: Group psychoeducation

• Study Type: Interventional
• Enrollment (Anticipated): 504
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Santa Margarida de Montbui, Barcelona, Spain, 08710
      • Centre d'Atenció Primària (CAP) Santa Margarida de Montbui

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; The intervention group will participate in psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from Primary Care, consisting of health education on chronic physical illness and depressive symptoms. Group psychoeducation.	Behavioral: Group psychoeducation; Educational group sessions for patients with depression and physical comorbidities in order to improve the degree of control of their illnesses
NO_INTERVENTION: Control Group; Usual clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in rate of remission of depression	Changes in the score of the BDI-II scale	At 12 months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in rate of remission of depression	Changes in the score of the BDI-II scale	At 3 months of follow-up
Changes in the control of DM2	Changes in HbA1c	At 12 months of follow-up
Changes in the control of COPD	Changes in FEV1	At 12 months of follow-up
Changes in the control of asthma	Changes in FEV1	At 12 months of follow-up
Changes in the control of Ischemic heart disease	Changes in LDL cholesterol	At 12 months of follow-up
Referrals to mental health	Number of visits to mental health centers	At 12 months of follow-up
Record of therapeutic compliance	Morisky-Green test	At 12 months of follow-up
Changes in the quality of life	Measured by the EuroQol scale (EQ-5D)	At 12 months of follow-up
Quantification of the use of services	Number of hospital admissions	At 12 months of follow-up
Satisfaction with the intervention	Survey at the end of the intervention	At 3 months of follow-up
Adherence to the intervention	Number of assisted sessions	At 3 months of follow-up
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
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

Collaborators and Investigators

• Sponsor: Jordi Gol i Gurina Foundation
• Collaborators: Carlos III Health Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 6, 2017
• Primary Completion (ANTICIPATED): June 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (ACTUAL): August 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder
• Other Study ID Numbers: PI16/01272

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No