Psycho-Education Physical Exercise Effects: does treating subsyndromal depression improve depression- and diabetes-related outcomes?

ISRCTN	ISRCTN05673017
DOI	https://doi.org/10.1186/ISRCTN05673017
Protocol serial number	091410
Sponsor	European Foundation for the Study of Diabetes (EFSD) (Germany)
Funder	European Foundation for the Study of Diabetes (EFSD) (Germany)

Submission date: 27/07/2010
Registration date: 11/08/2010
Last edited: 09/09/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

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 (0)1 235 3935
Email	mirjana.pibernik@idb.hr

Study information

Primary study design	Interventional
Study design	Randomised controlled three-arm study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled comparison of psycho-education, physical exercise and treatment as usual in patients with diabetes and suffering from subsyndromal depression
Study acronym	PEPEE
Study objectives	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(s)	Ethics Committee of the Vuk Vrhovac University Clinic, 01/07/2010
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/09/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	59
Key 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)
Key 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)
Date of first enrolment	01/09/2010
Date of final enrolment	01/09/2013

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
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2015		Yes	No
Results article	results	15/07/2015		Yes	No
Protocol article	protocol	21/01/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes