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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
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
- Changes in rate of remission of depression [ Time Frame: At 12 months of follow-up ]Changes in the score of the BDI-II scale
- 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
- Changes in the control of DM2 [ Time Frame: At 12 months of follow-up ]Changes in HbA1c
- Changes in the control of COPD [ Time Frame: At 12 months of follow-up ]Changes in FEV1
- Changes in the control of asthma [ Time Frame: At 12 months of follow-up ]Changes in FEV1
- Changes in the control of Ischemic heart disease [ Time Frame: At 12 months of follow-up ]Changes in LDL cholesterol
- Referrals to mental health [ Time Frame: At 12 months of follow-up ]Number of visits to mental health centers
- Record of therapeutic compliance [ Time Frame: At 12 months of follow-up ]Morisky-Green test
- Changes in the quality of life [ Time Frame: At 12 months of follow-up ]Measured by the EuroQol scale (EQ-5D)
- Quantification of the use of services [ Time Frame: At 12 months of follow-up ]Number of hospital admissions
- Satisfaction with the intervention [ Time Frame: At 3 months of follow-up ]Survey at the end of the intervention
- Adherence to the intervention [ Time Frame: At 3 months of follow-up ]Number of assisted sessions
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
|Contact: María Isabel Fernández-San Martín||0034 675 782 firstname.lastname@example.org|