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Sports therapy for depression in the German health care system

Sports therapy for depression in the German health care system: the STEP.De effectiveness trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28972230
Enrollment
480
Registered
2018-06-26
Start date
2018-08-17
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Depressive disorder (ICD-10: F32.0, F32.1, F33.0, F33.1, F34.1) or adjustment disorder (F43.2, F48.0, F43.8, F43.9, F41.2) Mental and Behavioural Disorders

Interventions

Current intervention as of 11/08/2022: Patients will be recruited via local community-based insurance carriers providing specialized treatment plans for psychotherapy in depression. Participants will

Sponsors

Social and Preventive Medicine, Universität Potsdam
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 11/08/2022: 1. Male and female patients aged between 18 and 65 years 2. Suffering from any of the following disorders as evinced by chart documentation and validated in confirmatory structured interviews (Structural Clinical Interview I for DSM - IV (SCID - I); Axis 1: psychological disorders, depression section): 2.1. Mild or moderate depressive episode (F 32.0, F 32.1) 2.2. Recurrent depressive disorder, current episode mild or moderate (F 33.0, F 33.1) 2.3. Dysthymia (F34.1) 2.4. Adjustment disorder (F43.2) 2.5. Neurasthenia F48.0 2.6. Other reactions to severe stress F43.8 2.7. Reaction to severe stress, unspecified F43.9 2.8. Mixed anxiety and depressive disorder F41.2 3. Ability to engage in regular physical exercise according to the adjusted Physical Readiness Questionnaire (Par-Q) 4. Basic skills in handling personal computer and/ or tablet as well as internet access _____ Previous inclusion criteria: Both male and female patients aged between 18 and 65 years suffering from any of the following disorders as evinced by chart documentation and validated in confirmatory structured interviews (Structural Clinical Interview I for DSM - IV (SCID - I); Axis 1: psychological disorders, depression section): 1. Mild or moderate depressive episode (F 32.0, F 32.1) 2. Recurrent depressive disorder, current episode mild or moderate (F 33.0, F 33.1) 3. Dysthymia (F34.1) 4. Adjustment disorder (F43.2) Ability to engage in regular physical exercise according to the adjusted Physical Readiness Questionnaire (Par-Q). Basic skills in handling personal computer and/ or tablet as well as internet access.

Exclusion criteria

Exclusion criteria: 1. Ongoing outpatient psychotherapy 2. Physical disability 3. Legal guardianship 4. Active substance dependence or severe use disorder 5. Other serious mental or neurological illness 6. Presence of long-term medication with benzodiazepines or opiates (several weeks) 7. High-dose (> .7 DDD) pharmacotherapy with tricyclics or neuroleptics

Design outcomes

Primary

MeasureTime frame
Depression severity measured with the Beck Depression Inventory (BDI-II) at baseline and immediately after the sports intervention

Secondary

MeasureTime frame
All ratings will be performed by raters partially blinded for the interventional character of the study at baseline, after two and four months, and two, six, and twelve months after the sports intervention: 1. Hamilton Rating Scale for Depression (HAM-D) 2. Work ability (WHO Disability Assessment Schedule 2.0, WHODAS 2.0; Work and Social Adjustment Scale, WSAS) 3. Physical activity (IPAQ) 4. Psychopathological symptoms (modified VDS90-R) 5. Self-efficacy (GSE-6) 6. Psychological need frustration and satisfaction (BPNSFS) 7. Quality of life (SF-12, EQ-5D) 8. Health care climate (HCCQ) 9. Sports motivation (BRQ-12) 10. Mindfulness (Mindful Attention Awareness Scale [MAAS]) 11. Telemetric physical activity recordings 12. Depression severity as assessed by the BDI at all timepoints will be used for secondary analyses to explore sustainability of treatment effects 13. Health insurance data will be used for health economic analysis using a difference-in-difference approach

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026