Condition category
Mental and Behavioural Disorders
Date applied
25/08/2008
Date assigned
04/09/2008
Last edited
03/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.idb.hr

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

http://www.mzos.hr

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

  1. 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.

Additional files

Editorial Notes