Clinical trial NCT03542396: Evaluation of a Group Therapeutic Exercise Program
Official title: ImPuls - a Group Therapeutic Exercise Intervention for the Outpatient Psychotherapeutic Context
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety Disorders
Primary Insomnia
ADHD
Keywords: Behaviour change techniques
Aerobic exercise
Mental disorders
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The current study aims to examine the efficacy (i.e., symptom reduction, increase of heart rate variability, improvement of sleep quality, increase of intrinsic motivation to engage in physical activity, increase of the level of physical activity) of a three-months manualized group exercise program, named ImPuls. The program contains supervised and non-supervised endurance training combined with behaviour change techniques. The manual was designed for patients with major depression, anxiety disorders, insomnia, and ADHD who are waiting for psychotherapeutic treatment. It is assumed that the program will improve the psychopathological symptoms of the different mental disorders. Heart rate variability, level of exercise, sleep quality, motivation and symptoms are measured by objective measures (physiological measurements, accelerometers) and subjective measures (structured interviews and questionnaires). In a randomized controlled trial, ImPuls will be evaluated (n = 38 intervention group vs. n = 37 control group). For four weeks, small group sessions of three to four people take place three times a week, combining endurance exercise (i.e., running) and behaviour change techniques, supervised by two therapists. The training is based on the actual evidence for effective therapeutic effects on psychopathological symptoms, individually adapted to each patient's fitness level (60-80% of the maximal heart rate) and lasts 30 minutes. In the following eight weeks, participants are encouraged to engage in physical activity independently for two to three times a week. It is assumed that the program will reduce symptoms of the different mental disorders as well as increase the heart rate variability, improve sleep quality, intrinsic motivation to engage in physical activity, and the engagement in physical activity. Safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in Symptom-Checklist-90®-Standard at Week 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
Secondary outcomes:
measure: Change from Baseline in Pittsburgh Sleep Quality Index at Week 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Change from Baseline in Sleep Questionnaire B - Revised version at Week 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Change from Baseline Score in Global Assessment of Functioning-Scale at Week 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Change From Baseline in Perceived Stress Scale at Week 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Change from Baseline in Heart rate Variability at Week 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Change From Baseline in German version of the 36-Item Short Form Health Survey at Week 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Change From Baseline in the Physical Activity, Exercise, and Sport Questionnaire at Week 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Physical activity (objective)
timeFrame: week 9
measure: Change From Baseline in Self Concordance of Sport- and Exercise-related Goals Scale at Week 5 and 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Change From Baseline in self-efficacy at Week 5 and 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Change From Baseline in strength of goal intention at Week 5 and 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Change From Baseline in implementation intentions at Week 5 and 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Change From Baseline in Volitional Intention Shielding at Week 5 and 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Change From Baseline in Physical Activity-related Health Competence Questionnaire at Week 13 and one year after study completion
timeFrame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
measure: Change from Baseline in the The Homburg's ADHS Scales for adults at Week 13
timeFrame: Baseline (week 0) and posttreatment assessment (week 13)
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University of Tubingen, Faculty of Science, Clinical Psychology and Psychotherapy
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Tuebingen
name: Sebastian Wolf, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.