Trial document




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  DRKS00024152

Trial Description

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Title

Efficacy and Cost Effectiveness of the Implementation of a Supervised,
Transdiagnostic Group-based Exercise Intervention Named ImPuls for Patients
With Major Depression, Panic Disorder, Agoraphobia, Post-traumatic Stress Disorder and
Nonorganic Insomnia Within a Naturalistic Outpatient Setting in Germany: a
Pragmatic RCT

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Trial Acronym

ImPuls

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URL of the Trial

https://innovationsfonds.g-ba.de/projekte/neue-versorgungsformen/impuls-starke-psyche-durch-motivation-und-bewegung.371

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Brief Summary in Lay Language

In Germany, 28 percent of the population is affected by a mental illness each year. The most common disorders include anxiety disorders, unipolar depression and sleep disorders. Expenditure on treatment in Germany amounted to more than 44 billion euros in 2015. In addition, there are further economic effects and productivity losses due to inability to work.

Endurance-oriented physical activity is a (cost-)effective form of therapy for mental illness. However, sports and exercise therapy concepts have not yet been systematically established in outpatient care.

The new form of care, named ImPuls, is designed to combine endurance-oriented sports activities with behavioral exercise therapy. Patients are referred to a study center by their family physician or psychotherapist and participate in ImPuls in groups of six - with supervision by exercise therapists. To support the transfer of physical activity into everyday life, patients are followed up by regular telephone contacts and an ImPuls app after the group sessions.

In ten study centers, 600 patients are being examined in a randomized controlled trial to determine what effect ImPuls has on psychological symptoms compared to standard care. At regular intervals, severity of the symptoms, costs of care and the exercise behavior of the participants are recorded. Questionnaires, routine data form healthcare providers and activity sensors are used for this purpose. In addition to analyzing the effectiveness and cost-effectiveness, the process of implementing ImPuls will also be evaluated. The project will be funded for three and a half years with approximately 3 million euros in total.

If successful, ImPuls could be implemented nationwide, extended to other indications (schizophrenia, ADHD, generalized anxiety) and integrated into education and (advanced) training structures.

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Brief Summary in Scientific Language

Exercise reduces symptoms in patients of various psychiatric disorders. The goal of the research project, is to evaluate the efficacy and cost effectiveness of a transdiagnostic group-based exercise intervention, named ImPuls, for
patients diagnosed with major depressive disorder, panic disorder, PTSD or nonorganic insomnia. ImPuls is intended to be an additional treatment within standard outpatient care in Germany.
The hypotheses are as follows:
1. Participants in the intervention group who receive ImPuls in addition to standard care demonstrate lower global symptom severity
at post-treatment assessment compared to a control group that receives only standard care.
2. Participants of the intervention group cause significantly less costs in the public health system compared to the control group at post-treatment assessment.
3a. The intervention leads to an increase in exercise
3b. Increase in exercise is associated with a reduction in global symptom severity
4. Significantly lower disorder-specific symptoms (depression, panic, PTSD and insomnia) wil be reported at post-treatment assessment by the intervention group compared to the control group.

ImPuls will be provided in ten regional study centers in Baden-Württemberg, a state in South-Western Germany, by exercise therapists. To carry out the ImPuls intervention, exercise therapists are required to have an academic or comparable basic qualification as physical activity and exercise professionals with a training period of at least 3 years and a specific additional therapeutic qualification DVGS e.V. with 5 ECTS overall.
Patients will be recruited mainly from outpatient clinics and practices and diagnosed by trained psychologists. Six eligible patients will be randomly allocated (block randomization) to either the intervention or control group. The group-allocation sequence is concealed from the research team responsible for data collection and management until the planned unblinding.
Outcome data will be assessed pre treatment, after six months (post-1) and after
twelve months (post-2).

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Individual participant data that underlie the results reported in this article after deidentification will be published: text, tables, figures and appendices.
Documents that will be further shared: Study protocol, statistical analysis plan, analytic code, aggregated individual study data. Routine/administrative data from health insurances will not be mage available.

Anyone who whiches to access the data has access to the data.

Study protocol and statistical analysis plan will be published iseparately (before completion of recruitment).

Analytic code and aggregated individual study data will be made available at an online repository (for example the repository psycharchives). This
Data will be made available immediately after publication (or within the review process).

Participants give informed consent to publish their data after deidentification.

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Organizational Data

  •   DRKS00024152
  •   2021/02/05
  •   [---]*
  •   yes
  •   Approved
  •   888/2020B01, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
  •   F33.2 -  Recurrent depressive disorder, current episode severe without psychotic symptoms
  •   F40.0 -  Agoraphobia
  •   F41.0 -  Panic disorder [episodic paroxysmal anxiety]
  •   F43.1 -  Post-traumatic stress disorder
  •   F51.0 -  Nonorganic insomnia
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Interventions/Observational Groups

  •   Experimental group: ImPuls

    Behavioral: ImPuls in addition to standard care.

    A transdiagnostic group-based exercise intervention with a duration of six months. It aims to integrate individualized exercise behavior into life routines. Exercise is intended to be performed with a weekly frequency of 2-3 times, a duration of at least 30 minutes and at least with moderate instensity of > 64 % HRmax. To carry out the ImPuls intervention, exercise therapists are required to have an academic or comparable basic qualification as physical activity and exercise professionals with a training period of at least 3 years and a specific additional therapeutic qualification DVGS e.V. with 5 ECTS overall. The first four weeks of the program are mainly supervised. Patients take part in group sessions of two hours that combine outdoor running with patient education, aiming to prepare for the intended exercise and to integrate behaviour change techniques (BCTs) to promote sustained exercise behavior. In weeks 5 to 24, patients engage in individualized mainly non-supervised exercise 2-3 times a week, which is accompanied by a smartphone app and regular phone calls with the exercise therapist. Patients further receive standard care.
  •   Active Comparator: Standard Care.

    Patients recieve the usual psychiatric treatment for outpatient care in Germany which can be psychotherapy or medication, a combination of both, (partial) inpatient treatment or receiving no treatment due to waiting times or refusal of any standard treatment.

    Other Names: Treatment as Usual (TAU)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Brief Symptom Inventory (BSI-18)
The BSI-18 is an 18-item short form of the Brief Symptom Inventory (BSI; Franke, 2000). It is intended as a screen for psychiatric disorders and psychological distress and consists of three 6-item subscales: somatization, depression, and anxiety. The Global Severity Index (GSI) will be calculated to determine transdiagnostic symptom severity.

[Time Frame: Pre-treatment, after 6 months (Post-1), after 12 months (Post-2)]

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Secondary Outcome

Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989):
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score produce one global score, that represents different aspects of subjective sleep quality (e.g. insomnia symptoms, total sleep duration, sleep latency...).
[Time Frame: Pre-treatment, after 6 months (Post-1), after 12 months (Post-2)].

Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001):
The PHQ-9 is a 9-item depression module from the full PHQ, which is a questionnaire assessing 8 different diagnoses. As a severity measure, the PHQ-9 score can range from 0 to 27.
[Time Frame: Pre-treatment, after 6 months (Post-1), after 12 months (Post-2)].

Generalized Anxiety Disorder Scale -7 (GAD-7; Spitzer et al., 2007):
THE GAD-7 consists of seven items (four-point Likert scale) that capture symptom severity of general anxiety symptoms and from which a total score (0-21) is formed.
[Time frame: Pre-assessment, after 6 months (Post-1), after 12 months (Post-2)].

Posttraumatic Stress Disorder Checklist (PCL-5; Krüger-Gottschalk et al., 2017):
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. A total symptom severity score (range - 0-80) can be obtained by summing up the scores for each of the 20 items.
[Time Frame: Pre-treatment, after 6 months (Post-1), after 12 months (Post-2)].

Insomnia Severity Index, German version (ISI):
The ISI forms a total score ranging from 0 to 28 from seven self-report items (five-point Likert scale) that capture the type, severity, and impact of insomnia.
[Time frame: Pre-assessment, after 6 months (Post-1), after 12 months (Post-2)].

Bewegungs- und Sportaktivität Fragebogen (BSA; Fuchs et al., 2015): [Physical Activity and Exercise Questionnaire]
The BSA is a self-report questionnaire in German to measure the amount of exercise. Participants specify type, duration, and frequency of exercise in the last four weeks. The Exercise Activity Index indicates the average minutes of exercise per week.
[Time Frame: Pre-treatment, after 6 months (Post-1), after 12 months (Post-2)].

Objective physical activity assessment, measured by physical activity sensors:
The sensors measure the physical activity of a person (in minutes/week) based on the acquisition of acceleration in three dimensions and atmospheric air pressure. Moreover the sensor also records the rotation rate and the ambient temperature. It measures Step Counts, Activity Classes, and Energy Expenditure
[Time Frame: The sensor will be carried 7 days each at pre-treatment, after 6 months (Post-1), after 12 months (Post-2)]

EQ-5D-5L (Greiner et al., 2008)
The EQ-5D-5L questionnaire is a measure for assessing health-related quality of life (HRQOL). The EQ-5D-5L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The respondent's self-rated health status is recorded as a single index value, with higher scores for higher HRQOL.
[Time Frame: Pre-treatment, after 6 months (Post-1), after 12 months (Post-2)]

Healthcare costs:
Healthcare costs due to outpatient and inpatient treatments, outpatient medication and days of incapacity to work are assessed. Therefore routine/administratve data from the two involved health insurances is analyzed. In addition, cost parameters resulting from the intervention and implementation are considered.
[Time frame: six months before pre-assessment to 12 months after pre-assessment (post-2)].

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
  • other 
  • University Medical Center 
  • other 
  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2021/02/22
  •   375
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Patients with one of the following ICD-10 diagnoses will be included in the study: F32.1, F32.2, F33.1, F33.2, F40.0, F41.0, F43.1; F51.0. The program is aimed at patients aged 18 to 65 years.

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Exclusion Criteria

Exercising of at least twice a week for at least 30 minutes, continuously over a period of 6 weeks within the last 3 months before study diagnosis, sports-medical contraindication (medical consultation) and acute mental illness: Schizophrenia (ICD-10 F20), Bipolar disorder (ICD-10 F31), mental and behavioral disorders due to psychotropic substances (ICD-10 F10.0, F10.2-F10.9; F11.0, F11.2-F11.9; F12. 0, F12.2-F12.9; F13.0, F13.2-F13.9; F14.0, F14.2-F14.9; F15.0, F15.2-F15.9; F16.0, F16.2-F16.9; F17.2-F17.9; F18.0, F18.2-F18.9; F19.0, F19.2-F19.9) or eating disorders (ICD-10 F50).

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Addresses

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    • Institut für Sportwissenschaft, Bildungs- und Gesundheitsforschung, Eberhard Karls-Universität Tübingen
    • Mr.  Dr.  Sebastian  Wolf 
    • Gartenstraße 19
    • 72074  Tübingen
    • Germany
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    • Klinische Psychologie und Psychotherapie, Ludwig-Maximilians Universität München
    • Mr.  Prof. Dr.  Thomas  Ehring 
    • Leopoldstr. 13
    • 80802  München
    • Germany
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    • Gesundheitsökonomie, Technische Universität München
    • Ms.  Prof. Dr.  Leonie  Sundmacher 
    • Georg-Brauchle-Ring 60/62
    • 80992  München
    • Germany
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    • Institut für Sportwissenschaft, Bildungs- und Gesundheitsforschung, Eberhard Karls-Universität Tübingen
    • Mr.  Prof. Dr.  Gorden  Sudeck 
    • Wächterstraße 67
    • 72074  Tübingen
    • Germany
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    • Institut für Medizinische Psychologie, Universitätsklinikum Tübingen
    • Mr.  Dr.  Ander  Ramos Murguialday 
    • Schleichstraße 5
    • 72076  Tübingen
    • Germany
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    • Deutscher Verband für Gesundheitssport und Sporttherapie e. V.
    • Ms.  Angelika  Baldus 
    • Vogelsanger Weg 48
    • 50354  Hürth-Efferen
    • Germany
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    • AOK Baden-Württemberg
    • Presselstraße 19
    • 70191  Stuttgart
    • Germany
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    •   0049 800 2652965
    •   [---]*
    •   info at bw.aok.de
    •   [---]*
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    • Techniker Krankenkasse
    • Bramfelder Straße 140
    • 22305  Hamburg
    • Germany
    end of 1:1-Block address other
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    •   0049 800 285 85 85
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    •   service at tk.de
    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Institut für Sportwissenschaft, Bildungs- und Gesundheitsforschung, Eberhard Karls-Universität Tübingen
    • Mr.  Dr.  Sebastian  Wolf 
    • Gartenstraße 19
    • 72074  Tübingen
    • Germany
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  • start of 1:1-Block address public-contact
    • Institut für Sportwissenschaft, Bildungs- und Gesundheitsforschung, Eberhard Karls-Universität Tübingen
    • Mr.  Dr.  Sebastian  Wolf 
    • Gartenstraße 19
    • 72074  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss[German Innovation Fund of the Federal Joint Committee]
    • Gutenbergstraße 13
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.