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

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ClinicalTrials.gov Identifier: NCT03243799
Recruitment Status : Not yet recruiting
First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

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, 6 and 12 months.


Condition or disease Intervention/treatment Phase
Depressive Disorder Behavioral: Group psychoeducation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Psychoeducational Group Intervention Conducted by Primary Health Care Nurses in Patients With Depression and Physical Comorbidity
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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



Primary Outcome Measures :
  1. Changes in rate of remission of depression [ Time Frame: At 12 months of follow-up ]
    Changes in the score of the BDI-II scale


Secondary Outcome Measures :
  1. Changes in rate of remission of depression [ Time Frame: At 3 and 6 months of follow-up ]
    Changes in the score of the BDI-II scale

  2. Changes in the control of DM2 [ Time Frame: At 12 months of follow-up ]
    Changes in HbA1c

  3. Changes in the control of COPD [ Time Frame: At 12 months of follow-up ]
    Changes in FEV1

  4. Changes in the control of asthma [ Time Frame: At 12 months of follow-up ]
    Changes in FEV1

  5. Changes in the control of Ischemic heart disease [ Time Frame: At 12 months of follow-up ]
    Changes in LDL cholesterol

  6. Referrals to mental health [ Time Frame: At 12 months of follow-up ]
    Number of visits to mental health centers

  7. Record of therapeutic compliance [ Time Frame: At 12 months of follow-up ]
    Morisky-Green test

  8. Changes in the quality of life [ Time Frame: At 12 months of follow-up ]
    Measured by the EuroQol scale (EQ-5D)

  9. Quantification of the use of services [ Time Frame: At 12 months of follow-up ]
    Number of hospital admissions

  10. Satisfaction with the intervention [ Time Frame: At 3 months of follow-up ]
    Survey at the end of the intervention

  11. Adherence to the intervention [ Time Frame: At 3 months of follow-up ]
    Number of assisted sessions



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 11 on the BDI-II scale and confirmation of major depression according to DSM-IV criteria by the psychiatric interview "Mini international neuropsychiatric interview" (MINI).
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243799


Contacts
Contact: María Isabel Fernández-San Martín 0034 675 782 689 mifsanmartin.bcn.ics@gencat.cat

Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Carlos III Health Institute

Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03243799     History of Changes
Other Study ID Numbers: PI16/01272
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders