Evaluation of a Group Therapeutic Exercise Program

NCT ID: NCT03542396

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-11-09

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.

Conditions

Depression; Anxiety Disorders; Primary Insomnia; ADHD

Keywords

Behaviour change techniques; Aerobic exercise; Mental disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ImPuls

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

Group Type: EXPERIMENTAL

ImPuls

Intervention Type: BEHAVIORAL

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ImPuls

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastian Wolf, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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

Tübingen, Baden-Wurttemberg, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 34158000 (View on PubMed)

Other Identifiers

ImPuls_2018

Identifier Type: -

Identifier Source: org_study_id