Effects of psychoeducation on treatment outcomes in depressed diabetic patients

ISRCTN	ISRCTN58745372
DOI	https://doi.org/10.1186/ISRCTN58745372
Protocol serial number	045-0450961-0959
Sponsor	Ministry of Science, Education and Sports (Croatia)
Funder	Ministry of Science, Education and Sports (Croatia)

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

Contact information

Dr Mirjana Pibernik-Okanovic
Scientific

Vuk Vrhovac University Clinic
Zagreb
10000
Croatia

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effects of a psychoeducational course on treatment outcomes in mildly to moderately depressed diabetic patients
Study acronym	EPOT
Study objectives	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(s)	The study was approved by the Ethics Committee, Vuk Vrhovac Institute in 2006 (ref: No.03-188)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Depressive symptoms, measured by the Center for Epidemiologic Studies- Depression (CES-D) scale at 6- and 12- month follow-up.
Key secondary outcome measure(s)	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)
Completion date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	330
Key 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
Key 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
Date of first enrolment	01/09/2008
Date of final enrolment	01/09/2010

Locations

Countries of recruitment

Croatia

Study participating centre

Vuk Vrhovac University Clinic

Zagreb
10000
Croatia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes