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

NCT03243799 | Unknown

• 1 other identifier: PI16/01272
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Changes in rate of remission of depression

  Changes in the score of the BDI-II scale

  At 12 months of follow-up

Secondary Outcomes (13)

• Changes in rate of remission of depression

  At 3 months of follow-up

• Changes in the control of DM2

  At 12 months of follow-up

• Changes in the control of COPD

  At 12 months of follow-up

• Changes in the control of asthma

  At 12 months of follow-up

• Changes in the control of Ischemic heart disease

  At 12 months of follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Usual clinical care

Interventions

Group psychoeducation BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Carlos III Health Institute: collaborator

Study Sites (1)

Centre d'Atenció Primària (CAP) Santa Margarida de Montbui

Santa Margarida de Montbui, Barcelona, 08710, Spain

Location

Related Publications (1)

• 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.

  PMID: 31242892 DERIVED

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 9, 2017
• Study Start: November 6, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 31, 2019

Record last verified: 2019-05

Locations

ES (1)