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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

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 - ImPuls

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024152
Enrollment
375
Registered
2021-02-05
Start date
2021-02-22
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

F32.1 F32.2 F33.1 F33.2 F40.0 F41.0 F43.1 F51.0

Interventions

Group 1: 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 individua

Sponsors

Institut für Sportwissenschaft, Bildungs- und Gesundheitsforschung, Eberhard Karls-Universität Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
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)]

Secondary

MeasureTime frame
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 me

Countries

Germany

Contacts

Public ContactSebastian Wolf

Institut für Sportwissenschaft, Bildungs- und Gesundheitsforschung, Eberhard Karls-Universität Tübingen

sebastian.wolf@uni-tuebingen.de0049 7071 76136

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 14, 2026