Contact information
Type
Scientific
Primary contact
Dr Mirjana Pibernik-Okanovic
ORCID ID
Contact details
Vuk Vrhovac University Clinic
Zagreb
10000
Croatia
+385 1 2353 935
mirjana.pibernik@idb.hr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
045-0450961-0959
Study information
Scientific title
Effects of a psychoeducational course on treatment outcomes in mildly to moderately depressed diabetic patients
Acronym
EPOT
Study hypothesis
Screening depressive symptoms in diabetic patients attending their regular medical check-ups, and including those with severe depressive symptoms in a psychoeducational intervention accompanied by a structured follow-up will improve their awareness of the interaction between depression and diabetes, and provide them with necessary support to make an informed decision about self-help and depression treatment. It is also hypothesised that improving patients' activation and their personal competence will positively affect the course of depressive symptoms, diabetes-associated emotional problems, glycaemic control and perceived quality of life.
Ethics approval
The study was approved by the Ethics Committee, Vuk Vrhovac Institute in 2006 (ref: No.03-188)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Patient information can be found at: http://www.idb.hr/EPOT.pdf
Condition
Diabetes mellitus, depression
Intervention
The intervention comprises 3 interactive small group meetings (8-10 members), each lasting for 90 minutes. The included topics will be:
1. Symptoms of depression; interaction of depression and diabetes
2. Alleviating burden of depression through activities and problem solving
3. Associations between depression and cognitive processes - thoughts, beliefs and attitudes that induce and maintain depression
The first two meetings are held within one week of each other, and the third one after one month. Patients will be provided with a self-help manual for overcoming depressive disturbances, based on the "Coping with depression" course by P.M. Lewinshon (see below for reference). For this study purpose, the programme has been partially modified and adjusted to specific emotional problems related to diabetes. Besides general information (prevalence and cause of depression, interaction with diabetes, treatment modalities, prevention of relapse), exercises to recognise and modify cognitive patterns that contribute to depression maintenance are included.
A run-in period aimed at assessing patients' knowledge and diabetes self-care-related skills will precede the intervention.
The patients in the control group will be given feedback about the severity of their depressive symptoms and receive counselling about appropriate forms of treatment.
Ref: Lewinshon PM, Antonnucio DO, Steinmetz JL et al. The Coping with Depression Course: A Psychoeducational Intervention for Unipolar Depression. Castalia Press, Eugene, OR, 1984.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Depressive symptoms, measured by the Center for Epidemiologic Studies- Depression (CES-D) scale at 6- and 12- month follow-up.
Secondary outcome measures
The following will be assessed at 6- and 12-month follow-up:
1. Diabetes-related emotional problems, assessed by the Problem Areas in Diabetes (PAID) scale
2. Diabetes self-care, assessed by the Summary of Diabetes Self Care Activities (SDSCA) questionnaire
3. Long-term glycaemic control as determined by HbA1c
4. Perceived quality of life, assessed by the 12-item short form health survey (SF-12)
Overall trial start date
01/09/2008
Overall trial end date
01/09/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with diabetes mellitus
2. Both males and females, aged 18-65 years
3. Patients who have reported elevated depressive symptoms as assessed by the Patient Health Questionnaire-Depression (PHQ-9) and the Center for Epidemiologic Studies-Depression (CES-D) questionnaire
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
330
Participant exclusion criteria
1. Poor literacy
2. Drinking problems
3. Co-morbid organic psychiatric disorder
4. Diagnosis of psychosis
5. Severe visual impairment
6. Major depressive disorder
Recruitment start date
01/09/2008
Recruitment end date
01/09/2010
Locations
Countries of recruitment
Croatia
Trial participating centre
Vuk Vrhovac University Clinic
Zagreb
10000
Croatia
Sponsor information
Organisation
Ministry of Science, Education and Sports (Croatia)
Sponsor details
Donje Svetice 38
Zagreb
10000
Croatia
+385 (0)1 4569 000
ured@mzos.hr
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Science, Education and Sports (Croatia)
Alternative name(s)
Ministry of Science, Education and Sports, MZOS
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Croatia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19709404
Publication citations
-
Results
Pibernik-Okanovic M, Begic D, Ajdukovic D, Andrijasevic N, Metelko Z, Psychoeducation versus treatment as usual in diabetic patients with subthreshold depression: preliminary results of a randomized controlled trial., Trials, 2009, 10, 78, doi: 10.1186/1745-6215-10-78.