Effects of psychoeducation on treatment outcomes in depressed diabetic patients

ISRCTN ISRCTN58745372
DOI https://doi.org/10.1186/ISRCTN58745372
Secondary identifying numbers 045-0450961-0959
Submission date
25/08/2008
Registration date
04/09/2008
Last edited
03/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Mirjana Pibernik-Okanovic
Scientific

Vuk Vrhovac University Clinic
Zagreb
10000
Croatia

+385 1 2353 935
mirjana.pibernik@idb.hr

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Patient information can be found at: http://www.idb.hr/EPOT.pdf
Scientific titleEffects of a psychoeducational course on treatment outcomes in mildly to moderately depressed diabetic patients
Study acronymEPOT
Study objectivesScreening 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(s)The study was approved by the Ethics Committee, Vuk Vrhovac Institute in 2006 (ref: No.03-188)
Health condition(s) or problem(s) studiedDiabetes mellitus, depression
InterventionThe 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 typeOther
Primary outcome measureDepressive symptoms, measured by the Center for Epidemiologic Studies- Depression (CES-D) scale at 6- and 12- month follow-up.
Secondary outcome measuresThe 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 study start date01/09/2008
Completion date01/09/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants330
Key inclusion criteria1. 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
Key exclusion criteria1. Poor literacy
2. Drinking problems
3. Co-morbid organic psychiatric disorder
4. Diagnosis of psychosis
5. Severe visual impairment
6. Major depressive disorder
Date of first enrolment01/09/2008
Date of final enrolment01/09/2010

Locations

Countries of recruitment

  • Croatia

Study participating centre

Vuk Vrhovac University Clinic
Zagreb
10000
Croatia

Sponsor information

Ministry of Science, Education and Sports (Croatia)
Government

Donje Svetice 38
Zagreb
10000
Croatia

+385 (0)1 4569 000
ured@mzos.hr
http://www.mzos.hr
ROR logo https://ror.org/0507etz14

Funders

Funder type

Government

Ministry of Science, Education and Sports (Croatia)
Government organisation / National government
Alternative name(s)
Ministry of Science, Education and Sports, MZOS
Location
Croatia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 26/08/2009 Yes No
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