- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03542396
Evaluation of a Group Therapeutic Exercise Program
ImPuls - a Group Therapeutic Exercise Intervention for the Outpatient Psychotherapeutic Context
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Baden-Württemberg
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Tuebingen, Baden-Württemberg, Germany, 72070
- University of Tubingen, Faculty of Science, Clinical Psychology and Psychotherapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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
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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
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NO_INTERVENTION: 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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Symptom-Checklist-90®-Standard at Week 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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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)
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Pittsburgh Sleep Quality Index at Week 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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The Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) retrospectively measures sleep quality over the last four weeks.
The components add up to a total score that can vary from 0 to 21, with a higher score indicating reduced sleep quality.
A cut-off value of five allows a division into "good" and "bad" sleepers.
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Change from Baseline in Sleep Questionnaire B - Revised version at Week 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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With the self-report questionnaire Sleep Questionnaire B - Revised version (Schlaffragebogen B, SF-B/R; Görtelmeyer, 2011), the sleep behavior and sleep experience of the past two weeks can be described and assessed quantitatively and qualitatively.
The questionnaire assesses the following 4 sleep indices: Difficulty to Fall Asleep and Difficulty to Sleep Through (1 = "no difficulties" to 4 = "severe and lasting difficulties"), Premature Awakening (1 = "no premature awakening" to 5 = "being severe and lasting premature awakening") and General Sleep Characterization (1 = "negative characterization" to 5 = "positive characterization").
The four scores (averages) range from 1 to 5 since the most scales follow this five-point format.
Higher scores of the first three indices indicate more sleep difficulties whereas higher scores of the last index (General Sleep Characterization) indicate a better characterization.
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Change from Baseline Score in Global Assessment of Functioning-Scale at Week 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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The Global Assessment of Functioning-Scale (GAF-Skala; American Psychiatric Association, 2000) is a scale which is used to record the general functional level on axis V of the DSM-IV.
On this scale, only the mental, social or professional functions are assessed.
The Global Assessment of Functioning-Skala is used to track the clinical progress of patients.
The rating is based on the therapist's evaluation.
The patient can be asked optionally if the therapist is not sure about the patient's general function.
Global functioning is registered on a scale of 1 to 100, with 1 being the lowest and 100 being the highest score of global functioning.
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Change From Baseline in Perceived Stress Scale at Week 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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The Perceived Stress Scale (PSS; Cohen, Kamarck, & Mermelstein, 1983) is the most widely used instrument to measure perceived stress.
The self-assessment scale consists out of 10 items and measures the degree to which a situation is appraised as stressful on a 5-point Likert-Scale ranging from 0 = "never" to 4 = "very often".
All items summed up build a total score indicating the level of perceived stress.
Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Change from Baseline in Heart rate Variability at Week 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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The heart rate variability (HRV) is an indicator for chronic stress and is measured by the ECG and activity sensor ekgMove (Movisens GmbH, Karlsruhe, Germany). HRV indices are the RMSSD (the square root of the squared mean of the sum of all differences of successive RR intervals) and the high frequency domain (HF; 0.15 - 0.4 Hz) measured by the ecg- and activity sensor ekgMove (Movisens GmbH, Karlsruhe, Deutschland). HRV indices are the RMSSD (the square root of the squared mean of the sum of all differences of successive RR intervals) and the high frequency domain (HF; 0.15 - 0.4 Hz) |
Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Change From Baseline in German version of the 36-Item Short Form Health Survey at Week 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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The 36-Item Short Form Health Survey (SF-36, Morfeld, Kirchberger, & Bullinger, 2011) is a self-report questionnaire which captures the quality of life of patients across eight dimensions of subjective health: Physical functioning, physical role function, physical pain, general health perception, vitality, social functioning, emotional role function and mental well-being.
With a single item, the current state of health is also inquired in comparison to last year.
For each variable item scores are coded, summed and transformed on to a scale from 0 (worst possible health state) to 100 (best possible health state).
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Change From Baseline in the Physical Activity, Exercise, and Sport Questionnaire at Week 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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The Physical Activity, Exercise, and Sport Questionnaire (Bewegungs- und Sportaktivitätfragebogen, BSA-F; Fuchs, Klaperski, Gerber, & Seelig, 2015) is a self-report questionnaire which measures physical activities in three areas: activity at work, leisure time activity and exercise activity.
Participants are asked to specify whether they are currently performing one or more physical activities regularly and to indicate the frequency (per week) and the duration in minutes (per session) for each activity.
Only activities that involve larger groups of skeletal muscles are considered to construct a Physical Activity Index (minutes of physical activity per week).
The higher the Physical Activity Index the more the person engages in exercise activities.
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Physical activity (objective)
Time Frame: week 9
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Differences of the physical activity level (moderate to vigorous intensity) using the accelerometer Move II ((Movisens GmbH, Karlsruhe, Germany).
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week 9
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Change From Baseline in Self Concordance of Sport- and Exercise-related Goals Scale at Week 5 and 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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The Self Concordance of Sport- and Exercise-related Goals Scale (SKK-Scale, Seelig & Fuchs, 2006) is a self-report questionnaire which measures how strongly the athletic goal intention matches the person's personal interests and values.
Four subscales with three items each indicate the intrinsic, identified, introjected and extrinsic motivation of being physically active.
Response format is a 4-point-Likert-scale ranging from 1 = "not true" to 4 = "true".
A general index for self-concordance of sport- and exercise-related goals (SKK index) will be formed by summing up the identified and intrinsic means scores and subtracting the introjected and extrinsic mean scores.
The lowest possible index value is -10 and the highest is +10.
A high positive value indicates a strong self-concordance.
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Change From Baseline in self-efficacy at Week 5 and 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Three different scopes of exercise-related self-efficacy are assessed (vgl.
Göhner, Seelig, & Fuchs, 2009).
Each scope is measured by one item on a 6-point Likert-scale ranging from 0 = "I don't feel capable at all" to 5 = "I feel 100 per cent capable".
The scores of each item will be combined into one mean value with higher scores indicating a stronger self-efficacy.
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Change From Baseline in strength of goal intention at Week 5 and 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Strength of goal intention is assessed with one item (vgl.
Göhner et al., 2009).
Response format is a 6-point Likert-scale ranging from 0 = "I don't have this intention at all" to 5 = "I do have a strong intention".
A higher score indicates a stronger goal intention.
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Change From Baseline in implementation intentions at Week 5 and 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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The self-report scale implementation intentions (vgl.
Göhner et al., 2009) measures whether the person know which physical activity they plan to perform in the following time.
A second activity can be named.
If the answer is "yes", the person is asked to note the named activity or activities.
Subsequently, participants are asked if they would already know the location and time they would perform it as well as how they would get there, how often and with whom they would perform this activity.
Positive answers will be summed up to build a score for implementation intentions (including naming the activity and planning details).
A higher score indicates stronger implementation intentions.
The score can range from 0 to 12.
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Change From Baseline in Volitional Intention Shielding at Week 5 and 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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The index Volitional Intention Shielding (VIS-index, vgl.
Göhner et al., 2009) consists of the subscales "Perceived Barriers" and "Counter Strategies".
The subscale Perceived Barriers measures how strongly barriers keep the person from exercising.
On a list with 19 possible barriers, the participant can indicate how strongly these barriers (on a 4-point Likert-scale ranging from 1 = "not at all" to 4 = "very much") keep him from exercising.
The mean of the 19 scores build the subscale Perceived Barriers.
The subscale Counter Strategies indicates possible ways to overcome those barriers.
A list presents 15 possible counter strategies.
Response format is dichotomous with 1 = "Yes, I use this strategy" and 0 = "No, I don't use this strategy".
The subscale Counter Strategies is the mean of the 15 scores.
The quotient of the two subscales builds the VIS-index (range 0-1).
The higher the VIS-index, the more successful is the intention shielding.
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Change From Baseline in Physical Activity-related Health Competence Questionnaire at Week 13 and one year after study completion
Time Frame: Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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The Physical Activity-related Health Competence Questionnaire (Sudeck & Pfeifer, 2016) is a self-report questionnaire which certain aspects of physical activity-related health competence on a Likert scale from 1 = "strongly disagree" to 4 = "strongly agree".
Sub-competencies are 1) movement Competence (6 items), 2) Control Competence (3 items), and 3) Physical-activity-specific self-regulation competence (4 items).
All items will be summed, and the total score indicates the level of physical activity-related health competence.
Individual scores can range from 13 to 52 with higher scores indicating higher physical activity-related health competence.
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Baseline (week 0), posttreatment assessment (week 13), and follow-up assessment (one year after posttreatment assessment)
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Change from Baseline in the The Homburg's ADHS Scales for adults at Week 13
Time Frame: Baseline (week 0) and posttreatment assessment (week 13)
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The Homburg's ADHS Scales for adults (Homburger ADHS-Skalen für Erwachsene, HASE; Rösler, Retz-Junginger, Retz, & Stieglitz, 2007) serves for the diagnosis of ADHD in adulthood.The instrument consists of four separate procedures. For the current study, two of them were used: (1) The Wender Utah Rating Scale - German version (WURS-K) is used for retrospective diagnosis of childhood ADHD symptoms. (2) The ADHD self-assessment scale (ADHD-SB) includes the 18 diagnostic criteria of DSM-IV and of the ICD-10 research version. The individual characteristics can be scaled from 0 to 3 with higher scores indicating a higher symptom severity. |
Baseline (week 0) and posttreatment assessment (week 13)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sebastian Wolf, Dr., University Hospital Tuebingen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ImPuls_2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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