NCT03542396

Brief Summary

Moderate to vigorous physical activity can reduce symptoms of mental disorders like major depression, anxiety disorders, insomnia, and ADHD. However, in Germany there are no group therapeutical exercise programs for psychotherapy patients in an outpatient context. The current study aims to examine the effectiveness of a manualized exercise program, named ImPuls, which consists of a supervised and non-supervised endurance training in moderate to vigorous intensity and behaviour change techniques.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2020

Completed
Last Updated

November 20, 2020

Status Verified

December 1, 2019

Enrollment Period

2.7 years

First QC Date

April 25, 2018

Last Update Submit

November 19, 2020

Conditions

DepressionAnxiety DisordersPrimary InsomniaADHD

Keywords

Behaviour change techniquesAerobic exerciseMental disorders

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Symptom-Checklist-90®-Standard at Week 13 and one year after study completion

    The Symptom-Checklist-90®-Standard (SCL-90®-S, Franke, 2014) was used to identify participants' impairment of physical and mental symptoms. The SCL-90®-S is a self-report questionnaire which captures the subjectively perceived impairment of a person's physical and mental symptoms on various scales. For this study, the scales of Anxiety, Depression, Phobic anxiety, Uncertainty in social contact and compulsiveness were used. Symptoms are registered on a 5-point Likert-Scale ranging from 0 = "being no manifestation of symptoms" to 4 = "being a very strong manifestation of symptoms". Scores will be transformed into T-values with higher scores indicating increasing abnormality (A T-value ≥ 60 indicates clinical abnormality)

    Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)

Secondary Outcomes (15)

  • Change from Baseline in Pittsburgh Sleep Quality Index at Week 13 and one year after study completion

    Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)

  • Change from Baseline in Sleep Questionnaire B - Revised version at Week 13 and one year after study completion

    Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)

  • Change from Baseline Score in Global Assessment of Functioning-Scale at Week 13 and one year after study completion

    Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)

  • Change From Baseline in Perceived Stress Scale at Week 13 and one year after study completion

    Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)

  • Change from Baseline in Heart rate Variability at Week 13 and one year after study completion

    Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)

  • +10 more secondary outcomes

Study Arms (2)

ImPuls

EXPERIMENTAL

Participants receive an supervised exercise intervention and behaviour change techniques for 4 weeks and, after that, they are encouraged to engage in physical activity for 8 weeks independently. During this 8-week individual phase, patients have weekly phone contacts with a psychotherapist

Behavioral: ImPuls

Control

NO INTERVENTION

Participants do not receive any intervention. Participants receive treatment as usual, which means they are on a waiting list of an outpatient unit to receive individual psychotherapeutic treatment

Interventions

ImPulsBEHAVIORAL

Participants receive an supervised exercise intervention and behaviour change techniques for 4 weeks and, after that, they are encouraged to engage in physical activity for 8 weeks independently. During this 8-week individual phase, patients have weekly phone contacts with a psychotherapist

ImPuls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must have a primary DSM-5 diagnosis of depression (F32, F33, F34.1), anxiety disorder (F40- F44), ADHD (F90) or sleep disorders (F51)
  • Participants must be aged between 18 and 65 years
  • Have not changed their psychotropic drugs intake within the last two months
  • Must be physically healthy on the basis of a medical examination
  • Fluent in German
  • Must be waiting for psychotherapy (waiting list)

You may not qualify if:

  • Acute and remitted eating disorders (F50)
  • Antisocial personality disorder (F60.2) and borderline personality disorder (F60.3)
  • current alcohol or substance use disorder (dependence) (F10.2, F11.2, F12.2, F13.2, F14.2, F15.2, F16.2, F18.2, F19.2)
  • current somatic symptom disorder with predominant pain (45.1)
  • Lifetime Bipolar disorders (F31)
  • Acute suicidality
  • High fitness level (\> 1x moderate physical activity (endurance training for at least 30 minutes / week)
  • Having taken psychotropic drugs for less than two months
  • Start of psychotherapy or any psychotropic drugs during the program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tubingen, Faculty of Science, Clinical Psychology and Psychotherapy

Tübingen, Baden-Wurttemberg, 72070, Germany

Location

Related Publications (1)

  • Zeibig JM, Seiffer B, Sudeck G, Rosel I, Hautzinger M, Wolf S. Transdiagnostic efficacy of a group exercise intervention for outpatients with heterogenous psychiatric disorders: a randomized controlled trial. BMC Psychiatry. 2021 Jun 22;21(1):313. doi: 10.1186/s12888-021-03307-x.

    PMID: 34158000DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersSleep Initiation and Maintenance DisordersAttention Deficit Disorder with HyperactivityMental Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Study Officials

  • Sebastian Wolf, Dr.

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 31, 2018

Study Start

March 1, 2018

Primary Completion

November 9, 2020

Study Completion

November 9, 2020

Last Updated

November 20, 2020

Record last verified: 2019-12

Locations

DE(1)