Major Depressive DisorderNCT06229652
Stress Management in Depressive Disorder: Resilience Training vs. Yoga: Biological, Epigenetic, and Brain Correlates
A study testing RASMUS Resilience Training and Body-oriented Yoga in people with Major Depressive Disorder, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The aim of this clinical trial is to evaluate the effects of a Resilience and Stress Management Intervention Program (RASMUS) compared with yoga on stress perception, coping strategies, depressive symptoms, anxiety, resilience and quality of life in people diagnosed with major depressive disorder (MDD) in the short… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- RASMUS Resilience Training and Body-oriented Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2024to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of MDD,
- Outpatient care for at least 3 months,
- Ongoing psychopharmacological treatment,
- Age between 18 and 65 years,
- Knowledge of written and spoken German,
- MADRS score ≤ 34 (moderate severity of symptoms),
- Written informed consent.
Who cannot join
- Other Axis I psychiatric disorder (organic mental disorders, psychoactive substance use [excl. caffeine and nicotine abuse], schizophrenia, bipolar disorder, neurotic disorders [excl. anxiety disorders], eating disorders, acute suicidality)
- Severe somatic illnesses,
- Pregnancy/breastfeeding,
- Undertaking regular yoga practice (more than once per week) over the past 3 months,
- Current use of psychotherapy.
- Further exclusion criteria for the neuroimaging sub-study:
Show all 9Show fewer
- History of neurological trauma or trauma to the central nervous system,
- MRI contraindications (claustrophobia, metallic, electrical, magnetic or mechanically driven implants, tattoos on the head or neck or other clinically relevant contraindications)
- Positive drug urine test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University Innsbruck
Innsbruck, Tyrol, 6020
Fabienne Post, MD, +4351250482922, fabienne.post@i-med.ac.at
Nataliia Maronchuk, MSc, +4351250482544, nataliia.maronchuk@i-med.ac.at
About this study
Official title: The Impact of Stress Management Interventions on Stress Perception, Coping Strategies, and Residual Symptoms in Depression: a Randomized Controlled Trial Investigating Psychological, Biological, Epigenetic, and Brain Correlates
The aim of this clinical trial is to evaluate the effects of a Resilience and Stress Management Intervention Program (RASMUS) compared with yoga on stress perception, coping strategies, depressive symptoms, anxiety, resilience and quality of life in people diagnosed with major depressive disorder (MDD) in the short and long term.
In addition to psychological factors, biological parameters will be examined to define biomarkers involved in stress response. In the optional neuroimaging part, the effects of the planned interventions on the structure, metabolism and function of the brain will be investigated. The epigenetic part, which is also optional, will examine the effects of the planned interventions on the histone modifications.
Read the detailed description
The aim of this clinical trial is to evaluate the effects of a Resilience and Stress Management Intervention Program (RASMUS) compared with yoga on stress perception, coping strategies, depressive symptoms, anxiety, resilience and quality of life in people diagnosed with major depressive disorder (MDD) in the short and long term.
In addition to psychological factors, biological parameters will be examined to define biomarkers involved in stress response. In the optional neuroimaging part, the effects of the planned interventions on the structure, metabolism and function of the brain will be investigated. The epigenetic part, which is also optional, will examine the effects of the planned interventions on the histone modifications. A total of 80 participants per study arm are planned for both the MRI and epigenetic studies (20 per gender and per type of intervention).
150 outpatients diagnosed with MDD will be randomly assigned to one of two groups: an experimental group receiving RASMUS training, and a control group receiving body-oriented yoga. Both interventions will take place in a group setting of 10-12 participants once a week for one hour over a period of 10 weeks. RASMUS aims to build, reflect on and strengthen stress management strategies and resilience through mindfulness, self-compassion and self-care. Through body-oriented yoga, participants learn through physical exercises to better control and manage their perception of stress.
The planned duration of the clinical trial is 4 years. Individual participation in the study will last approximately 8 months and include 4 study visits. The first visit will take place after enrolment. The second and third visits will take place after the fifth and final intervention. The fourth visit will be six months later.
- Conditions
- Major Depressive Disorder
- Being tested
- RASMUS Resilience Training, Body-oriented Yoga
- Keywords
- Depression, Stress management, Coping, Resilience, Yoga
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RASMUS Resilience TrainingBehavioural
RASMUS stands for "Resilience through mindfulness, self-compassion and self-care" and is a German-language 10-week group resilience program with one training unit per week. The main content of the RASMUS is based on seven resilience factors, i.e. acceptance, optimism, taking responsibility, solution orientation, future orientation, role clarity, and network orientation including the aspects of mindfulness, self-compassion, and self-care.
RASMUS has been tested and certified according to the German Prevention Standard. The Central Prevention Test Center has awarded the seal of approval for the areas of exercise, nutrition, stress management/relaxation, and addictive substance consumption. Accordingly, this training program has been certified as a prevention course that is recognized by the German statutory health insurance companies. Furthermore, RASMUS can and is already offered as a (group) online course.
Body-oriented YogaOther
Body-oriented Yoga following the Ashtanga style will be held by certified yoga teacher parallel to the experimental one hour per week 10 times.
Each yoga session will start with the proper warming up of the whole body with some stretching exercises (20 min). The main part will last about 30 minutes and consist of dynamic and active yoga sequencing containing sun salutation with a mix of exercises. A relaxation phase with controlled breathing and meditation-elements will finish the class (10 min). Each exercise has different complexity levels of implementation and will be adapted to the performance abilities of each participant.
| Study group | Role | What they receive |
|---|---|---|
| RASMUS Resilience Training | Experimental | RASMUS is a systematic, behavior-oriented group training in which the following methods are used: mindfulness exercises, exercises in self-compassion/guided meditations, knowledge transfer by means of a teaching talk/lecture, working out the topics in individual and small group work, group exercises, group discussion and exchange, train coping strategies: somatic, cognitive, and emotional levels, independent reflection on what has been learned, homework, weekly protocols, transfer to everyday life, questionnaires on resilience factors, mindfulness, and self-compassion for self-control, linking the course topics with one another. Receives: Behavioral: RASMUS Resilience Training |
| Body-oriented Yoga | Active comparator | The body-oriented yoga classes following the Ashtanga style will run in parallel to the RAMUS resilience group (one-hour, once a week). The yoga instructor will support each participant in the form of verbal and hands-on assistance. Receives: Other: Body-oriented Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Change Scores on the Stress Processing Questionnaire (SVF-ak) among Study Completers
Stress perception and stress processing modes in the sense of state characteristics will be assessed with the Stress Processing Questionnaire (SVF-ak) (Janke \& Erdmann, 1997; Janke et al., 1985; Kühn, 1986). The SVF-ak retrospectively asks about the stress processing methods used during a previous stress phase/period. The short version of this instrument which will be used in this study consists of 42 questions for the assessment of the extent to which the 19 processing strategies of the SVF - supplemented by the subtest helplessness - were used in certain stressful situations. Subjects indicate on a 4-point scale ranging from 0 (in no case) to 3 (for sure/ with certainty), how often the thought formulated in the item "went through their mind in the previous situation".
Measured: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Total Change Scores on the Perceived Stress Scale (PSS-10) among Study Completers
The German version of the Perceived Stress Scale (PSS-10) by Klein et al. (2016) will be used to measure excessive demands and the perception of stress. Subjects indicate on a 5-point Likert scale ranging from null (never) to four (very often) the extent to which situations in their own lives were unpredictable, uncontrollable, and overwhelming in the past month.
Measured: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Secondary outcomes (6)
Total Change Scores on the State-Trait-Anxiety Inventory (STAI) among Study Completers
Assessment of present and long-lasting anxiety levels will be carried out with the State-Trait-Anxiety Inventory (STAI) (Spielberger et al., 1970, German version by Laux et al., 1981). This is a widely used 40-items multiple-choice questionnaire assessing two dimensions of anxiety: anxiety as a trait (STAI-T), and anxiety as a transient emotional state (STAI-S). The STAI comprises 20 anxiety-related items rated on a 4-point Likert-scale ranging from 1 (not at all) to 4 (totally). Total scores range from 20 to 80 with higher scores indicating higher anxiety. Both state and trait anxiety will be assessed at baseline. At the other time points (mid, post1, post2) only state anxiety will be assessed.
Measured: 0 weeks (baseline), week 5 (mid), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Total Change Scores on the Resilience Scale for Adults (RSA) among Study Completers
Resilience will be evaluated using the Resilience Scale for Adults (RSA; Friborg, 2003; German version by Kaiser et al., 2019). This scale consists of 33 items rated on a 7-point intensity response scale and is used to measure both intra- and interpersonal protective factors. These protective factors promote adaptation to adversity and are examined in the following areas: self-perception, future planning, social competence, structural style, family cohesion, and social resources. Mean scores within each subscale are calculated or the total score.
Measured: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Total Change Scores on the WHO Quality of Life - Brief Version (WHOQOL-BREF) among Study Completers
Subjectively perceived quality of life will be assessed with the WHO Quality of Life - Brief Version quality of life measure (WHOQOL-BREF; Skevington et al., 2004). This is a 26-item self-report questionnaire to assess quality of life over the past two weeks in four domains: physical, psychological, social, and environmental. The items are rated on a five-point Likert scale from 1 (absent) to 5 (severe). The total scale is used in this study with higher scores indicating better quality of life.
Measured: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Total Change Scores on the Beck Depression Inventory-II (BDI-II) among Study Completers
The primary outcome - severity of depressive symptoms will be evaluated by means of the Beck Depression Inventory-II (BDI-II) (Beck et al., 1996; German translation by Kühner et al., 2007). The BDI-II is a 21-item self-report questionnaire to assess the severity of depression in the past two weeks. Each question has a set of four possible responses, ranging in intensity and resulting in a maximum total score of 63. Higher total scores indicate more severe depressive symptoms. BDI scores between 0 and 13 indicate absent to minimal depressive symptoms, from 14 to 19 mild symptoms, from 20 to 28 moderate symptoms, and from 29 to 63 severe depressive symptoms.
Measured: 0 weeks (baseline), week 5 (mid), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Total Change Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) among Study Completers
The severity of (residual) depressive symptoms will be evaluated using the MADRS. This observer-rated interview consists of 10 items (apparent sadness, reported sadness, internal tension, decreased sleep, decreased appetite, difficulty concentrating, fatigue, inability to feel, as well as pessimistic and suicidal thoughts), with each item scoring from 0 to 6. The total score ranges from 0 to 60 with higher scores reflecting a higher severity of symptoms. MADRS score ranging from 0 to 6 indicates absent to minimal depressive symptoms, from 7 to 19 mild depression, from 20 to 34 moderate depression, score of 35 and greater indicates severe symptoms and score of 60 indicates very severe depression.
Measured: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Alcohol/ tobacco consumption
Alcohol/ tobacco consumption will be assessed using the Tobacco and Alcohol Questionnaire (Sánchez-Gutiérrez et al., 2023)
Measured: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- University of Innsbruck, Austria
- Responsible party
- Sponsor
- Investigators
- Alex Hofer, Dr., Study director, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229652
- Sponsor's protocol ID
- Coping with Stress in MDD
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Stress Management Interventions on Stress Perception, Coping Strategies, and Residual Symptoms in Depression: a Randomized Controlled Trial Investigating Psychological, Biological, Epigenetic, and Brain Correlates
- ClinicalTrials.gov ID
- NCT06229652
- Acronym / sponsor ID
- Coping with Stress in MDD
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Stress management, Coping, Resilience, Yoga
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- University of Innsbruck, Austria
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial is to evaluate the effects of a Resilience and Stress Management Intervention Program (RASMUS) compared with yoga on stress perception, coping strategies, depressive symptoms, anxiety, resilience and quality of life in people diagnosed with major depressive disorder (MDD) in the short and long term.
In addition to psychological factors, biological parameters will be examined to define biomarkers involved in stress response. In the optional neuroimaging part, the effects of the planned interventions on the structure, metabolism and function of the brain will be investigated. The epigenetic part, which is also optional, will examine the effects of the planned interventions on the histone modifications.
Detailed description
The aim of this clinical trial is to evaluate the effects of a Resilience and Stress Management Intervention Program (RASMUS) compared with yoga on stress perception, coping strategies, depressive symptoms, anxiety, resilience and quality of life in people diagnosed with major depressive disorder (MDD) in the short and long term.
In addition to psychological factors, biological parameters will be examined to define biomarkers involved in stress response. In the optional neuroimaging part, the effects of the planned interventions on the structure, metabolism and function of the brain will be investigated. The epigenetic part, which is also optional, will examine the effects of the planned interventions on the histone modifications. A total of 80 participants per study arm are planned for both the MRI and epigenetic studies (20 per gender and per type of intervention).
150 outpatients diagnosed with MDD will be randomly assigned to one of two groups: an experimental group receiving RASMUS training, and a control group receiving body-oriented yoga. Both interventions will take place in a group setting of 10-12 participants once a week for one hour over a period of 10 weeks. RASMUS aims to build, reflect on and strengthen stress management strategies and resilience through mindfulness, self-compassion and self-care. Through body-oriented yoga, participants learn through physical exercises to better control and manage their perception of stress.
The planned duration of the clinical trial is 4 years. Individual participation in the study will last approximately 8 months and include 4 study visits. The first visit will take place after enrolment. The second and third visits will take place after the fifth and final intervention. The fourth visit will be six months later.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RASMUS Resilience Training | Experimental | Behavioral: RASMUS Resilience TrainingRASMUS is a systematic, behavior-oriented group training in which the following methods are used: mindfulness exercises, exercises in self-compassion/guided meditations, knowledge transfer by means of a teaching talk/lecture, working out the topics in individual and small group work, group exercises, group discussion and exchange, train coping strategies: somatic, cognitive, and emotional levels, independent reflection on what has been learned, homework, weekly protocols, transfer to everyday life, questionnaires on resilience factors, mindfulness, and self-compassion for self-control, linking the course topics with one another. |
| Body-oriented Yoga | Active comparator | Other: Body-oriented YogaThe body-oriented yoga classes following the Ashtanga style will run in parallel to the RAMUS resilience group (one-hour, once a week). The yoga instructor will support each participant in the form of verbal and hands-on assistance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of MDD,
- Outpatient care for at least 3 months,
- Ongoing psychopharmacological treatment,
- Age between 18 and 65 years,
- Knowledge of written and spoken German,
Key exclusion criteria (9 listed)
- Other Axis I psychiatric disorder (organic mental disorders, psychoactive substance use [excl. caffeine and nicotine abuse], schizophrenia, bipolar disorder, neurotic disorders [excl. anxiety disorders], eating disorders, acute suicidality)
- Severe somatic illnesses,
- Pregnancy/breastfeeding,
- Undertaking regular yoga practice (more than once per week) over the past 3 months,
- Current use of psychotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RASMUS Resilience TrainingRASMUS stands for "Resilience through mindfulness, self-compassion and self-care" and is a German-language 10-week group resilience program with one training unit per week. The main content of the RASMUS is based on seven resilience factors, i.e. acceptance, optimism, taking responsibility, solution orientation, future orientation, role clarity, and network orientation including the aspects of mindfulness, self-compassion, and self-care. RASMUS has been tested and certified according to the German Prevention Standard. The Central Prevention Test Center has awarded the seal of approval for the areas of exercise, nutrition, stress management/relaxation, and addictive substance consumption. Accordingly, this training program has been certified as a prevention course that is recognized by the German statutory health insurance companies. Furthermore, RASMUS can and is already offered as a (group) online course. | Behavioural | RASMUS Resilience Training |
| Body-oriented YogaBody-oriented Yoga following the Ashtanga style will be held by certified yoga teacher parallel to the experimental one hour per week 10 times. Each yoga session will start with the proper warming up of the whole body with some stretching exercises (20 min). The main part will last about 30 minutes and consist of dynamic and active yoga sequencing containing sun salutation with a mix of exercises. A relaxation phase with controlled breathing and meditation-elements will finish the class (10 min). Each exercise has different complexity levels of implementation and will be adapted to the performance abilities of each participant. | Other | Body-oriented Yoga |
Primary outcome
Total Change Scores on the Stress Processing Questionnaire (SVF-ak) among Study Completers
Time frame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Stress perception and stress processing modes in the sense of state characteristics will be assessed with the Stress Processing Questionnaire (SVF-ak) (Janke \& Erdmann, 1997; Janke et al., 1985; Kühn, 1986). The SVF-ak retrospectively asks about the stress processing methods used during a previous stress phase/period. The short version of this instrument which will be used in this study consists of 42 questions for the assessment of the extent to which the 19 processing strategies of the SVF - supplemented by the subtest helplessness - were used in certain stressful situations. Subjects indicate on a 4-point scale ranging from 0 (in no case) to 3 (for sure/ with certainty), how often the thought formulated in the item "went through their mind in the previous situation".
Total Change Scores on the Perceived Stress Scale (PSS-10) among Study Completers
Time frame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
The German version of the Perceived Stress Scale (PSS-10) by Klein et al. (2016) will be used to measure excessive demands and the perception of stress. Subjects indicate on a 5-point Likert scale ranging from null (never) to four (very often) the extent to which situations in their own lives were unpredictable, uncontrollable, and overwhelming in the past month.
6 secondary outcomes
Total Change Scores on the State-Trait-Anxiety Inventory (STAI) among Study Completers
Time frame: 0 weeks (baseline), week 5 (mid), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Total Change Scores on the Resilience Scale for Adults (RSA) among Study Completers
Time frame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Total Change Scores on the WHO Quality of Life - Brief Version (WHOQOL-BREF) among Study Completers
Time frame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Total Change Scores on the Beck Depression Inventory-II (BDI-II) among Study Completers
Time frame: 0 weeks (baseline), week 5 (mid), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Total Change Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) among Study Completers
Time frame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Alcohol/ tobacco consumption
Time frame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alex Hofer, Dr. study director
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RASMUS Resilience Training and Body-oriented Yoga in people with Major Depressive Disorder, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabienne Post, Dr. (+4351250482922, fabienne.post@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Change Scores on the Stress Processing Questionnaire (SVF-ak) among Study Completers (time frame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.