HealthyNCT05802875
Building Resilience During the COVID-19 Pandemic: a Randomized Controlled Trial
A study testing RASMUS Resilience Training and Progressive Muscle Relaxation in people with Healthy and COVID-19, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
This clinical trial is to test the efficacy of a Resilience Training (RASMUS) compared to an active control condition (Progressive Muscle Relaxation, PMR) on resilience, psychological distress, and other clinical variables in a group of people out of the general population with clinically relevant psychological… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, COVID-19, Distress, Emotional
- What is being tested?
- RASMUS Resilience Training and Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2022to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- GSI-T score (Mini-SCL) ≥63,
- BRS score <3,
- fluent German speakers,
- written informed consent.
Who cannot join
- Any psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (verified by Mini International Neuropsychiatric Interview [M.I.N.I.] 7.0.2), a history of nicotine or caffeine dependence is acceptable,
- currently engaged in any form of regular psychological therapy offered by psychologists and/or psychiatrists,
- currently engaged in any form of (group) interventions from other disciplines (social work, pedagogy, coaching, alternative therapy etc.)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck, Tyrol, 6020
Alex Hofer, MD, +4351250423669, a.hofer@i-med.ac.at
Nataliia Maronchuk, MSc, +4351250482544, nataliia.maronchuk@i-med.ac.at
About this study
This clinical trial is to test the efficacy of a Resilience Training (RASMUS) compared to an active control condition (Progressive Muscle Relaxation, PMR) on resilience, psychological distress, and other clinical variables in a group of people out of the general population with clinically relevant psychological symptoms in the context of the COVID-19 pandemic. In addition, this randomized, controlled, parallel-group study will test the efficacy of RASMUS and PMR in relation to brain structure, function, and metabolite levels. In summary, the main study examines the efficacy of two potentially helpful interventions to improve mental health, whereas the imaging sub-study investigates the potential effects of these interventions on brain volumetry and cortical thickness, on metabolite levels in stress-related brain regions, on brain responses, as well as on functional brain connectivity and communication.
Read the detailed description
Theoretical framework: The world is experiencing the evolving situation associated with the outbreak of the Corona Virus Disease-2019 (COVID-19), and there is more of need than ever for stress management and self-care. Several studies pointed out, that the COVID-19 pandemic is associated with highly significant levels of psychological distress that in many cases would meet the threshold for clinical relevance. Mental resilience is critical not only to adapt but also to thrive in these unprecedented times. When stress adversity or trauma strike, resilient people still experience anger, grief and pain, but they are able to keep functioning - both physically and psychologically. Resilience is a dynamic process and can potentially be trained.
Objectives: To test the efficacy of a comprehensive training program aimed at increasing resilience (RASMUS) and an active control condition (PMR) in relation to brain structure, function, and metabolite levels.
Methods: 192 people from the general population in Austria who suffer from psychological distress in the context of the COVID-19 pandemic will be randomly assigned to one of two treatment conditions: RASMUS or PMR. The outcome measurements are performed at the beginning, after the intervention (short-term effect) and at the end of the 6-month follow-up (long-term effect). Study assessments will be conducted via telephone and/or video conferencing platforms, and online questionnaires. RASMUS and PMR will be offered as (group-) online courses via video conferencing platforms. In addition, 100 study participants will be recruited for the neuroimaging sub-study (25/ sex/ condition) and will undergo magnetic resonance imaging (MRI) to investigate brain energy metabolism, functional connectivity, and brain responses during functional MRI. MRI will be performed at baseline, after the intervention (short-term effect) and at the end of a 6-month follow-up (long-term effect).
Innovation: While the main study examines the efficacy of two potentially helpful interventions to improve mental health, the current sub-study investigates the potential effects of these interventions on brain volumetry and cortical thickness, on metabolite levels in stress-related brain regions, on brain responses, as well as on functional brain connectivity and communication.
- Conditions
- Healthy, COVID-19, Distress, Emotional
- Being tested
- RASMUS Resilience Training, Progressive Muscle Relaxation
- Keywords
- Resilience, MRI
- Medical subject headings
- COVID-19
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.
Progressive Muscle RelaxationBehavioural
Progressive Muscle Relaxation is a representative relaxation technique used in a wide scope of disorders. Developed by the American physician E.Jacobson in the late 1920s, it is based on the finding that anxiety states are usually accompanied by increased muscle tension, while in resting states the muscles are relaxed. By applying this technique, an individual learns how to relax several muscle groups in the body.
In the context of the current project, PMR is chosen as the active control condition because it is a broadly accepted and easy-to-implement relaxation exercise that can be offered as a (group) online course and does not include specific contents of RASMUS.
| 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 |
| Progressive Muscle Relaxation | Active comparator | As a relaxation method with scientifically proven effects, progressive muscle relaxation aims at the conscious, voluntary tension and relaxation of certain muscle groups, which can bring the body into a state of deep relaxation. The application is not only effective in patients with various diseases, but also in healthy people. Receives: Behavioral: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Change Scores on Resilience Scale for Adults (RSA) among Study Completers
RSA is a multifactorial resilience questionnaire, which measures key factors contributing to high resilience, namely family support and cohesion, external support systems, and dispositional attitudes and behaviors. The following areas are investigated: perception of self, planned future, social competence, structural style, family cohesion, and social resources. It consists of 33 items which are to answer on the 7-point response scale
Measured: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Secondary outcomes (11)
Total Change Scores on World Health Organization Quality of Life (WHOQOL BREF)
The WHOQOL BREF (short form) is a tool assessing the subjective quality of life. It is a self-assessment, 24-item instrument widely used in international trials and consists of 4 domains: physical, psychological, social, and environment.
Measured: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Affective Style Questionnaire (ASQ)
The ASQ is a 20-item scale measuring the three affective styles concealing, adjusting, and tolerating, on a 5-point Likert scale ranging from (1) = "not true of me at all" to (5) = "extremely true of me".
Measured: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Self-Compassion Scale (SCS-D)
The SCS-D short form is a questionnaire for assessment of self-compassion which comprises 12 items with six subscales: self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification. The questions are to be answered on a 5-point Likert scale from 1 = "very rarely" to 5 = "very often".
Measured: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Mindful Attention and Awareness Scale (MAAS)
The MAAS is used to record self-assessed dispositional mindfulness in following three characteristics: (1) intentional, (2) related to the present moment, and (3) non-judgmental. The questionnaire includes 15 self-related statements which should be answered on a 6-point Likert scale ranging from (1) = "almost always" to (6) = "almost never".
Measured: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Perceived Stress Scale (PSS-10)
With PSS-10 Scale respondents report the degree to which situations in one's life have been unpredictable, uncontrollable, and overloaded in the past month on a 5-point Likert scale ranging from (0) = "never" to (4) = "very often".
Measured: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Brief COPE Inventory (COPE)
Brief COPE Inventory is applied to assess subjects disposition for using adaptive and maladaptive coping strategies. The maladaptive coping strategies include: denial, substance use, behavioural disengagement, self-distraction, self-blame. The adaptive coping strategies in turn are: active coping, emotional support, expression of emotions, instrumental support, positive reinterpretation, planning, humor, and acceptance.
Measured: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Insomnia Severity Index (ISI)
The ISI is a brief self-report instrument measuring the subjects' perception of insomnia. The ISI comprises seven items assessing the severity of sleep-onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0 - 4 scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
Measured: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
The ASSIST is used to assess smoking, alcohol and drugs use
Measured: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Brief Symptom Checklist (BSCL)
The BSCL is the extended version of the Mini-SCL and records subjectively perceived impairment of a person through 53 physical and psychological symptoms. It offers a multi-dimensional evaluation with the possibility of repeated measurements. Psychological stress is measured using nine scales: aggressiveness / hostility, anxiety, depression, paranoid thinking, phobic fear, psychoticism, somatization, insecurity in social contact, compulsiveness and three global parameters: Global Severity Index (GSI), Positive Symptom Distress Index (PSDI) and the Positive Symptom Total (PST)
Measured: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Fatigue Assessment Scale (FAS)
The general fatigue questionnaire consists of 10 items in total, five reflecting mental fatigue and physical fatigue. A score of ≥22 is used as a threshold to determine the presence of relevant fatigue.
Measured: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Hospital Anxiety and Depression Scale (HADS)
The HADS consists of two subscales measuring symptoms of depression (7 items) and anxiety (7 items) on a four-point Likert-Scale
Measured: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Apr 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Hofer, Dr., Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802875
- Sponsor's protocol ID
- Building resilience
- Status last verified
- Feb 2023
- First submitted
- 21 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Resilience During the COVID-19 Pandemic: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05802875
- Acronym / sponsor ID
- Building resilience
- Conditions
- Healthy, COVID-19, Distress, Emotional
- Keywords
- Resilience, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 7 Apr 2023 (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.
This clinical trial is to test the efficacy of a Resilience Training (RASMUS) compared to an active control condition (Progressive Muscle Relaxation, PMR) on resilience, psychological distress, and other clinical variables in a group of people out of the general population with clinically relevant psychological symptoms in the context of the COVID-19 pandemic. In addition, this randomized, controlled, parallel-group study will test the efficacy of RASMUS and PMR in relation to brain structure, function, and metabolite levels. In summary, the main study examines the efficacy of two potentially helpful interventions to improve mental health, whereas the imaging sub-study investigates the potential effects of these interventions on brain volumetry and cortical thickness, on metabolite levels in stress-related brain regions, on brain responses, as well as on functional brain connectivity and communication.
Detailed description
Theoretical framework: The world is experiencing the evolving situation associated with the outbreak of the Corona Virus Disease-2019 (COVID-19), and there is more of need than ever for stress management and self-care. Several studies pointed out, that the COVID-19 pandemic is associated with highly significant levels of psychological distress that in many cases would meet the threshold for clinical relevance. Mental resilience is critical not only to adapt but also to thrive in these unprecedented times. When stress adversity or trauma strike, resilient people still experience anger, grief and pain, but they are able to keep functioning - both physically and psychologically. Resilience is a dynamic process and can potentially be trained.
Objectives: To test the efficacy of a comprehensive training program aimed at increasing resilience (RASMUS) and an active control condition (PMR) in relation to brain structure, function, and metabolite levels.
Methods: 192 people from the general population in Austria who suffer from psychological distress in the context of the COVID-19 pandemic will be randomly assigned to one of two treatment conditions: RASMUS or PMR. The outcome measurements are performed at the beginning, after the intervention (short-term effect) and at the end of the 6-month follow-up (long-term effect). Study assessments will be conducted via telephone and/or video conferencing platforms, and online questionnaires. RASMUS and PMR will be offered as (group-) online courses via video conferencing platforms. In addition, 100 study participants will be recruited for the neuroimaging sub-study (25/ sex/ condition) and will undergo magnetic resonance imaging (MRI) to investigate brain energy metabolism, functional connectivity, and brain responses during functional MRI. MRI will be performed at baseline, after the intervention (short-term effect) and at the end of a 6-month follow-up (long-term effect).
Innovation: While the main study examines the efficacy of two potentially helpful interventions to improve mental health, the current sub-study investigates the potential effects of these interventions on brain volumetry and cortical thickness, on metabolite levels in stress-related brain regions, on brain responses, as well as on functional brain connectivity and communication.
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. |
| Progressive Muscle Relaxation | Active comparator | Behavioral: Progressive Muscle RelaxationAs a relaxation method with scientifically proven effects, progressive muscle relaxation aims at the conscious, voluntary tension and relaxation of certain muscle groups, which can bring the body into a state of deep relaxation. The application is not only effective in patients with various diseases, but also in healthy people. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- GSI-T score (Mini-SCL) ≥63,
- BRS score <3,
- fluent German speakers,
- written informed consent.
Key exclusion criteria (3 listed)
- Any psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (verified by Mini International Neuropsychiatric Interview [M.I.N.I.] 7.0.2), a history of nicotine or caffeine dependence is acceptable,
- currently engaged in any form of regular psychological therapy offered by psychologists and/or psychiatrists,
- currently engaged in any form of (group) interventions from other disciplines (social work, pedagogy, coaching, alternative therapy etc.)
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 |
| Progressive Muscle RelaxationProgressive Muscle Relaxation is a representative relaxation technique used in a wide scope of disorders. Developed by the American physician E.Jacobson in the late 1920s, it is based on the finding that anxiety states are usually accompanied by increased muscle tension, while in resting states the muscles are relaxed. By applying this technique, an individual learns how to relax several muscle groups in the body. In the context of the current project, PMR is chosen as the active control condition because it is a broadly accepted and easy-to-implement relaxation exercise that can be offered as a (group) online course and does not include specific contents of RASMUS. | Behavioural | Progressive Muscle Relaxation |
Primary outcome
Total Change Scores on Resilience Scale for Adults (RSA) among Study Completers
Time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
RSA is a multifactorial resilience questionnaire, which measures key factors contributing to high resilience, namely family support and cohesion, external support systems, and dispositional attitudes and behaviors. The following areas are investigated: perception of self, planned future, social competence, structural style, family cohesion, and social resources. It consists of 33 items which are to answer on the 7-point response scale
11 secondary outcomes
Total Change Scores on World Health Organization Quality of Life (WHOQOL BREF)
Time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Affective Style Questionnaire (ASQ)
Time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Self-Compassion Scale (SCS-D)
Time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Mindful Attention and Awareness Scale (MAAS)
Time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Perceived Stress Scale (PSS-10)
Time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Brief COPE Inventory (COPE)
Time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Insomnia Severity Index (ISI)
Time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Brief Symptom Checklist (BSCL)
Time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Fatigue Assessment Scale (FAS)
Time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Total Change Scores on Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Project WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alex Hofer, Dr. principal investigator
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 Progressive Muscle Relaxation in people with Healthy and COVID-19, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex Hofer, Dr. (+4351250423669, a.hofer@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 Resilience Scale for Adults (RSA) among Study Completers (time frame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)). 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 7 Apr 2023.