Contact information
Type
Scientific
Primary contact
Dr Mirjana Pibernik-Okanovic
ORCID ID
Contact details
Vuk Vrhovac University Clinic
Zagreb
10000
Croatia
+385 (0)1 235 3935
mirjana.pibernik@idb.hr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
091410
Study information
Scientific title
A randomised controlled comparison of psycho-education, physical exercise and treatment as usual in patients with diabetes and suffering from subsyndromal depression
Acronym
PEPEE
Study hypothesis
Early treatment of subsyndromal depression in patients with diabetes is expected to improve the patients' depressive symptoms and health status including indicators of metabolic control, subjectively perceived quality of life, diabetes-related distress and diabetes self-care.
Ethics approval
Ethics Committee of the Vuk Vrhovac University Clinic, 01/07/2010
Study design
Randomised controlled three-arm study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 diabetes/subsyndromal depression
Intervention
1. Psycho-educational intervention:
The intervention will comprise 6 interactive small-group meetings (4 - 6 members), each lasting for 60 - 90 minutes. The topics will include:
1.1. Symptoms of depression, interaction of depression and diabetes
1.2. Alleviating burden of depression through activities and problem solving
1.3. Associations between depression and cognitive processes - thoughts, beliefs and attitudes that induce and maintain depression, and developing a personal plan for managing problems in the future
The meetings will be held at weekly intervals. Patients will be provided with a self-help manual for overcoming depressive difficulties based on the "Coping with depression" course by P.M. Lewinsohn. The manual will be given to the participating patients prior to the first session in order to make them familiar with the course and to facilitate reflecting their own experiences. The manual's structure aims to stimulate introducing personal examples and making notes. The "Coping with depression" program is well-evaluated in both general population and medical patients. For the purpose of this study the program has been modified in two ways: it has been adjusted to address specific emotional problems related to diabetes, and also adapted for a shorter format of this intervention. Patients will also receive a workbook containing exercises to recognize depressive symptoms, become aware of daily activities patterns, acquire problem-solving techniques, and to recognize and modify cognitive patterns that contribute to maintenance of depression. The manual was tested for comprehensibility and clarity in a group of diabetic patients (N = 8) with different demographic and disease-related characteristics.
2. Physical activity intervention:
The intervention will comprise 6 small-group weekly sessions. The purpose of these sessions will be to educate patients about the interaction of physical activity, mood and diabetes and to increase their participation in a variety of physical activities with an emphasis on walking. The sessions will combine interactive lectures and exercise techniques (warm up-flexibility, strengthening and stretching exercises) that are considered suitable for the study participants. The educational topics will include:
2.1. Effects of exercise on mood
2.2. Short- and long-term effects of exercise on blood glucose and cardiovascular system
2.3. Strategies to develop and maintain a personal plan for regular exercise. The program has been developed by a professional trainer experienced in working with the diabetic population.
The sessions will be organised in a group format and led by a professional trainer. Exercise intensity will be measured by a cardiosport watch. The volume of physical activity will be monitored by a pedometer for one week preceding each point of measurement.
3. Depression screening followed by diabetes treatment as usual:
The patients screened for depression will be given an explanation of their result and informed about available treatment options. Follow-up data will be collected at the same points of measurement as in the treatment groups.
The total duration of the treatments (psycho-education; physical exercise) is six weeks. A one-year follow-up has been planned for all three arms of the trial.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Depressive symptoms, measured after the treatment (i.e. after six weeks for the "diabetes treatment as usual" group), and after six- and twelve-month follow-up periods.
Secondary outcome measures
1. Self-management of diabetes, measured at six weeks for the "diabetes treatment as usual" group, and after six- and twelve-month follow-up periods
2. Metabolic control, measured at six weeks for the "diabetes treatment as usual" group, and after six- and twelve-month follow-up periods
3. Diabetes-related distress, measured at six weeks for the "diabetes treatment as usual" group, and after six- and twelve-month follow-up periods
4. Health-related quality of life, measured at six weeks for the "diabetes treatment as usual" group, and after six- and twelve-month follow-up periods
5. Treatment satisfaction, measured after the treatment
Overall trial start date
01/09/2010
Overall trial end date
01/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Type 2 diabetes
2. Aged 18 - 60 years, either sex
3. Subsyndromal depression as determined by the screenings instruments (Patient Health Questionnaire-2 [PHQ-2], Center for Epidemiologic Studies Depression Scale [CES-D]) and the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)
4. Willing to participate (signing a written informed consent)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
59 participants per group
Participant exclusion criteria
1. Poor literacy
2. Mobility difficulties
3. Visual impairment
4. Drinking problems
5. Psychosis in personal medical history
6. Medical contraindications for physical exercise (heart attack or stroke in the past six months, chest pain, dizziness, fainting attacks, shortness of breath)
Recruitment start date
01/09/2010
Recruitment end date
01/09/2013
Locations
Countries of recruitment
Croatia
Trial participating centre
Vuk Vrhovac University Clinic
Zagreb
10000
Croatia
Sponsor information
Organisation
European Foundation for the Study of Diabetes (EFSD) (Germany)
Sponsor details
Rheindorfer Weg 3
Duesseldorf
40591
Germany
+49 (0)211 758469 0
Foundation@easd.org
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
European Foundation for the Study of Diabetes (EFSD) (Germany)
Alternative name(s)
EFSD
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Germany
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
Basic results (scientific)
Publication list
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21251307
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26174334
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26347775
Publication citations
-
Protocol
Pibernik-Okanović M, Ajduković D, Lovrenčić MV, Hermanns N, Does treatment of subsyndromal depression improve depression and diabetes related outcomes: protocol for a randomised controlled comparison of psycho-education, physical exercise and treatment as usual., Trials, 2011, 12, 17, doi: 10.1186/1745-6215-12-17.
-
Results
Pibernik-Okanović M, Hermanns N, Ajduković D, Kos J, Prašek M, Šekerija M, Lovrenčić MV, Does treatment of subsyndromal depression improve depression-related and diabetes-related outcomes? A randomised controlled comparison of psychoeducation, physical exercise and enhanced treatment as usual, Trials, 2015, 16, 1, 305, doi: 10.1186/s13063-015-0833-8.
-
Results
Vučić Lovrenčić M, Pibernik-Okanović M, Šekerija M, Prašek M, Ajduković D, Kos J, Hermanns N, Improvement in Depressive Symptoms Is Associated with Reduced Oxidative Damage and Inflammatory Response in Type 2 Diabetic Patients with Subsyndromal Depression: The Results of a Randomized Controlled Trial Comparing Psychoeducation, Physical Exercise, and Enhanced Treatment as Usual, Int J Endocrinol, 2015, 2015, 210406, doi: 10.1155/2015/210406.