Sports therapy for depression in the German health care system
| ISRCTN | ISRCTN28972230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28972230 |
| Secondary identifying numbers | 01NVF17050 |
- Submission date
- 21/06/2018
- Registration date
- 26/06/2018
- Last edited
- 13/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Both physical exercise and psychotherapy have been shown to have moderate to large effects for the treatment of depressive disorders. However, little is known about the effectiveness of sports therapy for depression in “real world” settings, e.g., implemented in a community healthcare setting. The aim of this study is to test the effectiveness of sports therapy as compared to short-term treatment-as-usual (TAU) psychotherapy in a sample of outpatients with depressive disorders including adjustment disorder in a community-based health care system in Germany.
Who can participate?
Patients aged 18 to 65 with depressive disorder or adjustment disorder
What does the study involve?
Participants are randomly allocated to 28 psychotherapists who are randomly allocated to the TAU psychotherapy or sports therapy condition. Control group psychotherapists provide short-term TAU psychotherapy only. Intervention psychotherapists provide a diagnostic assessment and offer monthly follow-up phone calls and psychological crisis interventions while patients undergo sports therapy over 4 months in groups of 4 to 12 people supervised by trained exercise professionals twice a week, yielding a total of 32 sessions of 60 min each. Sports therapy includes endurance exercise complemented by strength training, coordination and flexibility exercise. During sports therapy and TAU psychotherapy, mood, motivation, physical activity, emotion regulation, and cognition are assessed. Depression severity is measured at the start of the study and at the end of the sports therapy and at 2,-, 6-, and 12-months follow-up.
What are the possible benefits and risks of participating?
All possible participants receive an immediate appointment with a psychotherapist to figure out an individual optimal treatment strategy. If sports therapy is indicated, they can start immediately, or if another therapy is indicated or they are not eligible for the study they will receive psychotherapy care as usual. Sports therapy is free of charge for the participants (as is TAU psychotherapy). There is a small risk for sports injuries during the sports therapy comparable to the risks of leisure sports activities.
Where is the study run from?
Universität Potsdam (Germany)
When is the study starting and how long is it expected to run for?
April 2018 to March 2022
Who is funding the study?
Innovationsausschuss des Gemeinsamen Bundesausschusses (G-BA) [Innovation Fund of the Joint Federal Committee] (Germany)
Who is the main contact?
Prof. Michael Rapp
mrapp@uni-potsdam.de
Contact information
Scientific
Social and Preventive Medicine
Department of Sports and Health Sciences
Universität Potsdam
Am Neuen Palais 10
Potsdam
D- 14469
Germany
 ORCID ID |
0000-0001-5358-3674 |
|---|---|
| Phone | +49 (0)331 977 4095 |
| mrapp@uni-potsdam.de |
Study information
| Study design | Two-arm cluster-randomized non-inferiority effectiveness trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet (in German) |
| Scientific title | Sports therapy for depression in the German health care system: the STEP.De effectiveness trial |
| Study acronym | STEP.De |
| Study hypothesis | Compared to TAU psychotherapy, patients undergoing sports therapy will exhibit similar treatment effects in a community-based health care system over a period of 4 months. |
| Ethics approval(s) | Ethics Committee of University of Potsdam, 18/06/2018, No 17/2018 |
| Condition | 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) |
| Intervention | 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 be randomly assigned to 28 psychotherapists who are randomized to the TAU psychotherapy or sports therapy condition (cluster randomization at the psychotherapist level). Control group psychotherapists will provide TAU psychotherapy only. Intervention psychotherapists will provide a diagnostic assessment and offer monthly follow-up phone calls and psychological crisis interventions while patients undergo sports therapy over 4 months in groups of 4 to 12 people supervised by trained exercise professionals twice a week, yielding a total of 32 sessions of 60 min each. Sports therapy will include endurance exercise complemented by strength training, coordination and flexibility exercise. During sports therapy and TAU psychotherapy, electronic momentary assessment will be used for process analyses of mood, motivation, physical activity, emotion regulation, and cognition. _____ Previous intervention: Patients will be recruited via local community-based insurance carriers providing specialized treatment plans for psychotherapy in depression. Participants will be randomly assigned to 20 psychotherapists who are randomized to the TAU psychotherapy or sports therapy condition (cluster randomization at the psychotherapist level). Control group psychotherapists will provide TAU psychotherapy only. Intervention psychotherapists will provide a diagnostic assessment and offer monthly follow-up phone calls and psychological crisis interventions while patients undergo sports therapy over 4 months in groups of 4 to 12 people supervised by trained exercise professionals twice a week, yielding a total of 32 sessions of 60 min each. Sports therapy will include endurance exercise complemented by strength training, coordination and flexibility exercise. During sports therapy and TAU psychotherapy, electronic momentary assessment will be used for process analyses of mood, motivation, physical activity, emotion regulation, and cognition. |
| Intervention type | Behavioural |
| Primary outcome measure | Depression severity measured with the Beck Depression Inventory (BDI-II) at baseline and immediately after the sports intervention |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2018 |
| Overall study end date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 480 patients aged 18-65 years suffering from depressive disorder (recruited from three community-based health care systems in Berlin, Germany). The study is powered for cluster-adjusted regression analysis as a non-inferiority trial (= .05; 1-β = .95) based on an effect size of f = .3. Conventional repeated measures analysis of variance design with two measurement occasions yields a total sample size of 147 patients. Adjusting for 24 patients in 20 randomly assigned clusters (psychotherapists), and an intra-cluster correlation ICC of .08, using the design effect provided by Donner yields a total sample of 429 patients. Accounting for dropout, 480 patients will be recruited, each 240 in intervention and control group. |
| Total final enrolment | 393 |
| Participant 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. |
| Participant 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 |
| Recruitment start date | 17/08/2018 |
| Recruitment end date | 14/04/2021 |
Locations
Countries of recruitment
- Germany
Study participating centres
Am Neuen Palais 10
Potsdam
D- 14469
Germany
Habelschwerdter Allee 45
Berlin
D-14195
Germany
Berlin
D-10969
Germany
Berlin
D-13053
Germany
Berlin
D-10243
Germany
Frankfurt am Main
D-60486
Germany
Dingolfing
D-84130
Germany
Sponsor information
University/education
Am Neuen Palais 10
Potsdam
D-14460
Germany
| Phone | +49 (0)331 977 4095 |
|---|---|
| mrapp@uni-potsdam.de | |
| Website | https://www.uni-potsdam.de/soz-praev-med/index.html |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The trialists plan to submit a method paper concerning rationale, design and analysis plan in October 2018. Publication of primary trial analysis and results. Presentation of process analyses and secondary outcome variables at conferences and publication in peer-reviewed journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Dr Michael Rapp (mrapp@uni-potsdam.de). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/04/2020 | 17/04/2020 | Yes | No |
| Other publications | validation of the translated Work and Social Adjustment Scale (WSAS) | 21/06/2021 | 24/06/2021 | Yes | No |
Editorial Notes
13/09/2023: Total final enrolment added. The intention to publish date has been changed from 01/03/2023 to 01/03/2024.
11/08/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/07/2018 to 17/08/2018.
2. The recruitment end date has been changed from 31/03/2021 to 14/04/2021.
3. The intention to publish date has been changed from 01/11/2022 to 01/03/2023.
4. The condition has been changed from "Depressive disorder (ICD-10: F32.0, F32.1, F33.0, F33.1, F34.1) or adjustment disorder (F43.2)" to "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)".
5. The intervention has been changed.
6. The participant inclusion criteria have been changed.
7. The gender has been changed from 'Male' to 'Both'.
8. The Target number of participants has been changed from "480 patients aged 18-65 years suffering from depressive disorder (recruited from four community-based health care systems in Berlin, Germany). The study is powered for cluster-adjusted regression analysis as a non-inferiority trial (= .05; 1-β = .95) based on an effect size of f = .3. Conventional repeated measures analysis of variance design with two measurement occasions yields a total sample size of 147 patients. Adjusting for 24 patients in 20 randomly assigned clusters (psychotherapists), and an intra-cluster correlation ICC of .08, using the design effect provided by Donner yields a total sample of 429 patients. Accounting for dropout, 480 patients will be recruited, each 240 in intervention and control group." to "480 patients aged 18-65 years suffering from depressive disorder (recruited from three community-based health care systems in Berlin, Germany). The study is powered for cluster-adjusted regression analysis as a non-inferiority trial (= .05; 1-β = .95) based on an effect size of f = .3. Conventional repeated measures analysis of variance design with two measurement occasions yields a total sample size of 147 patients. Adjusting for 24 patients in 20 randomly assigned clusters (psychotherapists), and an intra-cluster correlation ICC of .08, using the design effect provided by Donner yields a total sample of 429 patients. Accounting for dropout, 480 patients will be recruited, each 240 in intervention and control group.".
9. BKK GILDEMEISTER SEIDENSTICKER has been removed from the trial participating centres.
10. The overall trial end date has been changed from 31/07/2021 to 31/03/2022.
11. The plain English summary has been updated accordingly.
24/06/2021: Publication reference added.
02/12/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2020 to 31/03/2021.
2. The overall end date was changed from 31/12/2021 to 31/07/2021.
17/04/2020: Publication reference added.
07/04/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2020 to 31/12/2020.
2. The overall end date was changed from 31/07/2021 to 31/12/2021.
3. The intention to publish date
4. The plain English summary was updated to reflect these changes.
