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

A randomised controlled comparison of psycho-education, physical exercise and treatment as usual in patients with diabetes and suffering from subsyndromal depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN05673017
Enrollment
59
Registered
2010-08-11
Start date
2010-09-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes/subsyndromal depression Nutritional, Metabolic, Endocrine Type 2 diabetes

Interventions

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 depr

Sponsors

European Foundation for the Study of Diabetes (EFSD) (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Croatia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026