Condition category
Mental and Behavioural Disorders
Date applied
21/06/2018
Date assigned
26/06/2018
Last edited
26/06/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 20 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 train 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?
1. Universität Potsdam (Germany)
2. Freie Universität Berlin (Germany)
3. BKK•VBU – Service Area Management (Germany)
4. Sport- und Gesundheitspark Berlin e.V.; Sports and Health Park / Centre for Sports Medicine (SGP) (Germany)
5. CONVEMA – Service Management GmbH (Germany)
6. BAHN BKK (Germany)
7. BMW BKK (Germany)
8. BKK GILDEMEISTER SEIDENSTICKER (Germany)

When is the study starting and how long is it expected to run for?
April 2018 to July 2021

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael A. Rapp

ORCID ID

http://orcid.org/0000-0001-5358-3674

Contact details

Social and Preventive Medicine
Department of Sports and Health Sciences
Universität Potsdam
Am Neuen Palais 10
Potsdam
D- 14469
Germany
+49 (0)331 977 4095
mrapp@uni-potsdam.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01NVF17050

Study information

Scientific title

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

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

Ethics Committee of University of Potsdam, 18/06/2018, No 17/2018

Study design

Two-arm cluster-randomized non-inferiority effectiveness trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet (in German)

Condition

Depressive disorder (ICD-10: F32.0, F32.1, F33.0, F33.1, F34.1) or adjustment disorder (F43.2)

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

Phase

Drug names

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 (MASS)
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 trial start date

01/04/2018

Overall trial end date

31/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

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.

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

01/07/2018

Recruitment end date

31/03/2020

Locations

Countries of recruitment

Germany

Trial participating centre

Social and Preventive Medicine, Department of Sports and Health Sciences
Universität Potsdam Am Neuen Palais 10
Potsdam
D- 14469
Germany

Trial participating centre

Clinical Psychology and Psychotherapy, Neurobiological mechanisms of therapeutic interventions
Freie Universität Berlin Habelschwerdter Allee 45
Berlin
D-14195
Germany

Trial participating centre

BKK·VBU – Service Area Management
Lindenstraße 67
Berlin
D-10969
Germany

Trial participating centre

Sport- und Gesundheitspark Berlin e.V.; Sports and Health Park / Centre for Sports Medicine (SGP)
Fritz-Lesch-Str. 29
Berlin
D-13053
Ghana

Trial participating centre

CONVEMA – Service Management GmbH
Karl-Marx-Allee 90A
Berlin
D-10243
Germany

Trial participating centre

BAHN BKK
Franklinstraße 54
Frankfurt am Main
D-60486
Germany

Trial participating centre

BMW BKK
Mengkofenerstraße 6
Dingolfing
D-84130
Germany

Trial participating centre

BKK GILDEMEISTER SEIDENSTICKER
Winterstraße 49
Bielefeld
D-33649
Germany

Sponsor information

Organisation

Social and Preventive Medicine, Universität Potsdam

Sponsor details

Am Neuen Palais 10
Potsdam
D-14460
Germany
+49 (0)331 977 4095
mrapp@uni-potsdam.de

Sponsor type

University/education

Website

https://www.uni-potsdam.de/soz-praev-med/index.html

Funders

Funder type

Government

Funder name

Innovationsausschuss des Gemeinsamen Bundesausschusses (G-BA) [Innovation Fund of the Joint Federal Committee]

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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).

Intention to publish date

01/04/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes