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
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Depression severity measured with the Beck Depression Inventory (BDI-II) at baseline and immediately after the sports intervention | — |
Secondary
| Measure | Time 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