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

Primary Purpose

Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Group psychoeducation
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

Usual clinical care

Outcomes

Primary Outcome Measures

Changes in rate of remission of depression
Changes in the score of the BDI-II scale

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2017
Last Updated
May 29, 2019
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Carlos III Health Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03243799
Brief Title
Effectiveness of a Psychoeducational Group Intervention in Patients With Depression and Physical Comorbidity
Acronym
PsiCoDep
Official Title
Effectiveness of a Psychoeducational Group Intervention Conducted by Primary Health Care Nurses in Patients With Depression and Physical Comorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Carlos III Health Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
504 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Usual clinical care
Intervention Type
Behavioral
Intervention Name(s)
Group psychoeducation
Intervention Description
Educational group sessions for patients with depression and physical comorbidities in order to improve the degree of control of their illnesses
Primary Outcome Measure Information:
Title
Changes in rate of remission of depression
Description
Changes in the score of the BDI-II scale
Time Frame
At 12 months of follow-up
Secondary Outcome Measure Information:
Title
Changes in rate of remission of depression
Description
Changes in the score of the BDI-II scale
Time Frame
At 3 months of follow-up
Title
Changes in the control of DM2
Description
Changes in HbA1c
Time Frame
At 12 months of follow-up
Title
Changes in the control of COPD
Description
Changes in FEV1
Time Frame
At 12 months of follow-up
Title
Changes in the control of asthma
Description
Changes in FEV1
Time Frame
At 12 months of follow-up
Title
Changes in the control of Ischemic heart disease
Description
Changes in LDL cholesterol
Time Frame
At 12 months of follow-up
Title
Referrals to mental health
Description
Number of visits to mental health centers
Time Frame
At 12 months of follow-up
Title
Record of therapeutic compliance
Description
Morisky-Green test
Time Frame
At 12 months of follow-up
Title
Changes in the quality of life
Description
Measured by the EuroQol scale (EQ-5D)
Time Frame
At 12 months of follow-up
Title
Quantification of the use of services
Description
Number of hospital admissions
Time Frame
At 12 months of follow-up
Title
Satisfaction with the intervention
Description
Survey at the end of the intervention
Time Frame
At 3 months of follow-up
Title
Adherence to the intervention
Description
Number of assisted sessions
Time Frame
At 3 months of follow-up
Title
Qualitative changes of the state of mind at the end of the intervention
Description
better, equal or worse
Time Frame
At 3 and 12 months of follow-up
Title
Qualitative changes of the state of health at the end of the intervention
Description
better, equal or worse
Time Frame
At 3 and 12 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre d'Atenció Primària (CAP) Santa Margarida de Montbui
City
Santa Margarida de Montbui
State/Province
Barcelona
ZIP/Postal Code
08710
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31242892
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.
Results Reference
derived

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

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