SchizophreniaNCT05712928
eMove - Dance/Movement Therapy Study
A study testing Dance/movement therapy (eMove) in people with Schizophrenia and Schizoaffective Disorder, run by Drexel University at 1 site in United States.
Trial summary
Schizophrenia is a chronic and severe mental disorder affecting 20 million people throughout the world and is the fourth leading cause of disability in the developed world. Currently, restrictions due to the COVID-19 pandemic, cause greater social withdrawal, reduced access to social support, lack of motivation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Dance/movement therapy (eMove)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Schizophrenia or schizoaffective disorder diagnosis,
- Able to speak and write English,
- Able to attend sessions via Zoom (including internet connection and a device with camera).
Who cannot join
- An organic brain disease or substance abuse as the primary diagnosis,
- A diagnosis of dementia or cognitive impairment that would interfere with competence to consent to participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Telehealth Dance/Movement Therapy on People With Chronic Schizophrenia
Schizophrenia is a chronic and severe mental disorder affecting 20 million people throughout the world and is the fourth leading cause of disability in the developed world. Currently, restrictions due to the COVID-19 pandemic, cause greater social withdrawal, reduced access to social support, lack of motivation, under-activity and loneliness for patients with schizophrenia. Given the prevalence of under-activity, interventions such as dance/movement therapy that use movement and dance to support intellectual, emotional, and motor functions of the body, can optimize the functioning of individuals with schizophrenia. There have been urgent calls for research on telehealth interventions to address the mental health needs caused by COVID-19 pandemic. To address this call, this study will test the feasibility and acceptability of a novel, 10-week dance/movement therapy protocol to promote activation in chronic schizophrenia designed for telehealth delivery. This study will be the first to examine the feasibility and preliminary effects of telehealth dance/movement therapy to promote activation in chronic schizophrenia. This study can contribute towards the development of telehealth interventions for treatment and rehabilitation of individuals with chronic schizophrenia.
Read the detailed description
Schizophrenia is a chronic and severe mental disorder affecting 20 million people throughout the world and is the fourth leading cause of disability in the developed world. Anhedonia, apathy, social withdrawal, and under-activity are common negative symptoms that have a detrimental impact on patients' overall quality of life. Activation, defined as physical, psychological and social engagement in everyday activities, is one of the most important psychosocial predictors of functional outcomes in people with schizophrenia. Psychosocial interventions designed to decrease negative symptoms and improve activation are considered crucial in the treatment of schizophrenia. Movement/body based interventions are one type of psychosocial interventions that are recommended. Given the prevalence of under-activity, interventions such as dance/movement therapy that focuses on movement behavior, emotional expression and social support, can optimize the functioning of individuals with schizophrenia. In addition, as many people with schizophrenia are treated on an outpatient basis and rarely require hospitalization, COVID-19 restrictions cause greater social withdrawal, reduced access to social support, lack of motivation, under-activity, and loneliness. Dance/movement therapy as a therapeutic holistic approach has unique potential to promote activity engagement in individuals with schizophrenia. Preliminary evidence suggests that dance/movement therapy enhances psychosocial functioning and reduces severity of negative symptoms of schizophrenia however to date no study has examined a telehealth delivery of dance/movement therapy to promote activation in this population. Therefore, the overarching goals of this feasibility study are (1) to evaluate the feasibility, acceptability and credibility of a telehealth dance/movement therapy treatment procedures and research protocol; (2) to assess and improve methodological procedures for conducting a randomized controlled trial (RCT) test of telehealth dance/movement therapy protocol; and (3) to determine preliminary effects of telehealth dance/movement therapy to promote activation in chronic schizophrenia. This feasibility study uses a single-group convergent mixed methods design in which quantitative (survey data) and qualitative (semi-structured exit interviews) data are collected concurrently and analyzed independently; the results are then compared and contrasted. The quantitative strand of the study will be a one-group pre/post-test design. For the qualitative strand, we will conduct semi-structured exit interviews post-intervention. The qualitative data will help to (1) obtain participant feedback on the intervention and its telehealth delivery, and (2) enhance our understanding of the impact of the intervention on activation in chronic schizophrenia.
This is the first study to examine the feasibility and preliminary effects of telehealth dance/movement therapy to promote activation in chronic schizophrenia. The findings from this study will provide (1) important methodological and protocol data and substantive pilot data necessary for the next phase of this line of research (a fully powered RCT to evaluate efficacy of treatment); and (2) will contribute towards the development of telehealth interventions for treatment and rehabilitation of individuals with chronic schizophrenia.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Dance/movement therapy (eMove)
- Keywords
- Dance/movement therapy, Creative arts therapies, Telehealth dance/movement therapy, Non-pharmacological intervention, Online intervention, Psychosocial functioning
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance/movement therapy (eMove)Behavioural
Ten weekly 60-minute individual dance/movement therapy telehealth sessions (eMove) delivered by a board-certified dance/movement therapist. eMove treatment protocol integrates movement techniques, creative embodiment, the non-verbal aspects of self-awareness and interpersonal communication in treatment. eMove sessions focus on helping the participant to increase physical activity level, increasing participants' energy levels and motivation to stay active and better cope with everyday activities, improving overall functioning; reducing severity of negative symptoms of schizophrenia; and providing participants with a sense of connection and social support by connecting with a therapist. In addition, sessions are individualized to the participant's presenting needs.
| Study group | Role | What they receive |
|---|---|---|
| Dance/movement therapy | Experimental | Ten weekly 60-minute individual dance/movement therapy telehealth sessions (eMove). Receives: Behavioral: Dance/movement therapy (eMove) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
Proportion of participants enrolled relative to total trial referrals
Measured: Baseline
Consent rates
Proportion of participants consented relative to total trial referrals
Measured: Baseline
Attrition rates
Proportion of participants who dropped-out/withdrawn relative to total enrolled including reason for drop-out/withdrawal
Measured: 12 weeks following receipt of treatment
Treatment compliance
Number of participants who completed 10 eMove sessions
Measured: 12 weeks following receipt of treatment
Treatment acceptance
Exit interview based on an interview protocol developed by the researcher
Measured: 12 weeks
Measurement completion
Proportion of participants who complete questionnaires
Measured: 12 weeks following receipt of treatment
Measurement burden
Ease to understand, quantity of questions, and fatigued experienced while completing the outcome assessments will be assessed during exit interview
Measured: Through study completion, a maximum of 12 weeks
Treatment Fidelity
Treatment fidelity questionnaire developed by the researcher; (range: 1 to 25 items; A total score of 80% and higher reflects adequate treatment fidelity).
Measured: Through study completion, a maximum of 12 weeks
Negative Symptoms (Self-report)
Measured by Self-evaluation of Negative Symptoms (SNS), a self-assessment of 20 items, allowing patients to evaluate themselves on the five dimensions of negative symptoms: social withdrawal, emotional range, alogia, avolition, and anhedonia. Each item is scored as either 2 (strongly agree), 1 (somewhat agree), or 0 (strongly disagree). The total score is the sum of the 20 items, ranging from 0 (no negative symptoms) to 40 (severe negative symptoms).
Measured: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Negative Symptoms (Clinical assessment)
Measured by Brief Negative Symptom Scale (BNSS) is a 13-item instrument, organized into 6 subscales, that asses negative symptoms (anhedonia, distress, asociality, avolition, blunted affect, and alogia). Items are scored on a 0 to 6 scale, with 0 indicating the symptom is absent and 6 indicating the symptom is severe. Items are summed for a total score that ranges between 0 and 78. The BNSS is administered as a semi-structured interview.
Measured: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Functional impairment (Self-report)
Measured by Sheehan Disability Scale (SDS), a 3 items self-report questionnaire assessing the extent that symptoms have caused the functional impairment in three inter-related domains; work/school, social and family life. The 3 items are measured on a 10 point visual analog scale. A single score of 5 or greater on any of the three scales are associated with significant functional impairment. The 3 items can also be summed into a single dimensional measure of global functional impairment that rages from 0 (unimpaired) to 30 (highly impaired).
Measured: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Health and disability (Self-report)
Measured by World Health Organization - Disability Assessment Schedule (WHODAS) 2.0 a 36-item self-report questionnaire assessing health and disability across six domains: cognition, mobility, self-care, getting along, life activities and participation. The 36 items are rated on a five-point Likert scale. The total score ranges from 0 to 100, higher scores representing greater disability.
Measured: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Movement assessment (Clinical assessment)
Measured by Movement Psychodiagnostic Inventory's (MPI) Action Inventory for Movement Session, an 15-item inventory measuring participation, self-related actions, eye contact, orientation, movement changes, types of interaction, torso/limb configurations while moving. (range: 0-2; higher scores reflect less action (higher severity in movement))
Measured: Through study completion, a maximum of 12 weeks
Secondary outcomes (5)
Patient Perception of Change (Self-report)
Measured by Patient's Global Impression of Change (PGIC) scale, a single item self-report scale (range: 1 (No change) to 7 (a great deal better)).
Measured: post-treatment, week 12 time point
Psychosocial Illness Impact (Self-report)
Measured by PROMIS® Psychosocial Illness Impact - Negative - Scale, a 5-point (from 1= Not at all to 5= Very much) rating scale is used in each of the 8 items; higher results mean more severe illness impact on functioning.
Measured: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Affect (Self-report)
Measured by PROMIS® Positive Affect Scale, A 5-point (from 1= Not at all to 5= Very much) rating scale is used in each of the 7 items; higher results mean better positive affect.
Measured: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Clinical Global Impression - Severity of Illness (Clinical assessment)
Measured by Clinical Global Impression (Severity of Illness [CGI-S]) is a single item 7-point scale measure of severity of illness. Range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).
Measured: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Clinical Global Impression - Global Improvement (Clinical assessment)
Measured by Clinical Global Impression (Measured by Global Improvement [CGI-I]) is a single item 7-point scale measure of global improvement. Range of responses from 1 (very much improved) through to 7 (very much worse).
Measured: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start29 Jun 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joke Bradt, PhD, Principal investigator, Drexel UniversityKarolina Bryl, PhD, Principal investigator, Drexel Unviersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712928
- Sponsor's protocol ID
- 2104008484
- Status last verified
- Jan 2023
- First submitted
- 14 Mar 2022
- Last updated
- 6 Feb 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 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Telehealth Dance/Movement Therapy on People With Chronic Schizophrenia
- ClinicalTrials.gov ID
- NCT05712928
- Acronym / sponsor ID
- 2104008484
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Dance/movement therapy, Creative arts therapies, Telehealth dance/movement therapy, Non-pharmacological intervention, Online intervention, Psychosocial functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Feb 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.
Schizophrenia is a chronic and severe mental disorder affecting 20 million people throughout the world and is the fourth leading cause of disability in the developed world. Currently, restrictions due to the COVID-19 pandemic, cause greater social withdrawal, reduced access to social support, lack of motivation, under-activity and loneliness for patients with schizophrenia. Given the prevalence of under-activity, interventions such as dance/movement therapy that use movement and dance to support intellectual, emotional, and motor functions of the body, can optimize the functioning of individuals with schizophrenia. There have been urgent calls for research on telehealth interventions to address the mental health needs caused by COVID-19 pandemic. To address this call, this study will test the feasibility and acceptability of a novel, 10-week dance/movement therapy protocol to promote activation in chronic schizophrenia designed for telehealth delivery. This study will be the first to examine the feasibility and preliminary effects of telehealth dance/movement therapy to promote activation in chronic schizophrenia. This study can contribute towards the development of telehealth interventions for treatment and rehabilitation of individuals with chronic schizophrenia.
Detailed description
Schizophrenia is a chronic and severe mental disorder affecting 20 million people throughout the world and is the fourth leading cause of disability in the developed world. Anhedonia, apathy, social withdrawal, and under-activity are common negative symptoms that have a detrimental impact on patients' overall quality of life. Activation, defined as physical, psychological and social engagement in everyday activities, is one of the most important psychosocial predictors of functional outcomes in people with schizophrenia. Psychosocial interventions designed to decrease negative symptoms and improve activation are considered crucial in the treatment of schizophrenia. Movement/body based interventions are one type of psychosocial interventions that are recommended. Given the prevalence of under-activity, interventions such as dance/movement therapy that focuses on movement behavior, emotional expression and social support, can optimize the functioning of individuals with schizophrenia. In addition, as many people with schizophrenia are treated on an outpatient basis and rarely require hospitalization, COVID-19 restrictions cause greater social withdrawal, reduced access to social support, lack of motivation, under-activity, and loneliness. Dance/movement therapy as a therapeutic holistic approach has unique potential to promote activity engagement in individuals with schizophrenia. Preliminary evidence suggests that dance/movement therapy enhances psychosocial functioning and reduces severity of negative symptoms of schizophrenia however to date no study has examined a telehealth delivery of dance/movement therapy to promote activation in this population. Therefore, the overarching goals of this feasibility study are (1) to evaluate the feasibility, acceptability and credibility of a telehealth dance/movement therapy treatment procedures and research protocol; (2) to assess and improve methodological procedures for conducting a randomized controlled trial (RCT) test of telehealth dance/movement therapy protocol; and (3) to determine preliminary effects of telehealth dance/movement therapy to promote activation in chronic schizophrenia. This feasibility study uses a single-group convergent mixed methods design in which quantitative (survey data) and qualitative (semi-structured exit interviews) data are collected concurrently and analyzed independently; the results are then compared and contrasted. The quantitative strand of the study will be a one-group pre/post-test design. For the qualitative strand, we will conduct semi-structured exit interviews post-intervention. The qualitative data will help to (1) obtain participant feedback on the intervention and its telehealth delivery, and (2) enhance our understanding of the impact of the intervention on activation in chronic schizophrenia.
This is the first study to examine the feasibility and preliminary effects of telehealth dance/movement therapy to promote activation in chronic schizophrenia. The findings from this study will provide (1) important methodological and protocol data and substantive pilot data necessary for the next phase of this line of research (a fully powered RCT to evaluate efficacy of treatment); and (2) will contribute towards the development of telehealth interventions for treatment and rehabilitation of individuals with chronic schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dance/movement therapy | Experimental | Behavioral: Dance/movement therapy (eMove)Ten weekly 60-minute individual dance/movement therapy telehealth sessions (eMove). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older,
- Schizophrenia or schizoaffective disorder diagnosis,
- Able to speak and write English,
- Able to attend sessions via Zoom (including internet connection and a device with camera).
Key exclusion criteria (2 listed)
- An organic brain disease or substance abuse as the primary diagnosis,
- A diagnosis of dementia or cognitive impairment that would interfere with competence to consent to participation.
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 |
|---|---|---|
| Dance/movement therapy (eMove)Ten weekly 60-minute individual dance/movement therapy telehealth sessions (eMove) delivered by a board-certified dance/movement therapist. eMove treatment protocol integrates movement techniques, creative embodiment, the non-verbal aspects of self-awareness and interpersonal communication in treatment. eMove sessions focus on helping the participant to increase physical activity level, increasing participants' energy levels and motivation to stay active and better cope with everyday activities, improving overall functioning; reducing severity of negative symptoms of schizophrenia; and providing participants with a sense of connection and social support by connecting with a therapist. In addition, sessions are individualized to the participant's presenting needs. | Behavioural | Dance/movement therapy |
Primary outcome
Recruitment rates
Time frame: Baseline
Proportion of participants enrolled relative to total trial referrals
Consent rates
Time frame: Baseline
Proportion of participants consented relative to total trial referrals
Attrition rates
Time frame: 12 weeks following receipt of treatment
Proportion of participants who dropped-out/withdrawn relative to total enrolled including reason for drop-out/withdrawal
Treatment compliance
Time frame: 12 weeks following receipt of treatment
Number of participants who completed 10 eMove sessions
Treatment acceptance
Time frame: 12 weeks
Exit interview based on an interview protocol developed by the researcher
Measurement completion
Time frame: 12 weeks following receipt of treatment
Proportion of participants who complete questionnaires
Measurement burden
Time frame: Through study completion, a maximum of 12 weeks
Ease to understand, quantity of questions, and fatigued experienced while completing the outcome assessments will be assessed during exit interview
Treatment Fidelity
Time frame: Through study completion, a maximum of 12 weeks
Treatment fidelity questionnaire developed by the researcher; (range: 1 to 25 items; A total score of 80% and higher reflects adequate treatment fidelity).
Negative Symptoms (Self-report)
Time frame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Measured by Self-evaluation of Negative Symptoms (SNS), a self-assessment of 20 items, allowing patients to evaluate themselves on the five dimensions of negative symptoms: social withdrawal, emotional range, alogia, avolition, and anhedonia. Each item is scored as either 2 (strongly agree), 1 (somewhat agree), or 0 (strongly disagree). The total score is the sum of the 20 items, ranging from 0 (no negative symptoms) to 40 (severe negative symptoms).
Negative Symptoms (Clinical assessment)
Time frame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Measured by Brief Negative Symptom Scale (BNSS) is a 13-item instrument, organized into 6 subscales, that asses negative symptoms (anhedonia, distress, asociality, avolition, blunted affect, and alogia). Items are scored on a 0 to 6 scale, with 0 indicating the symptom is absent and 6 indicating the symptom is severe. Items are summed for a total score that ranges between 0 and 78. The BNSS is administered as a semi-structured interview.
Functional impairment (Self-report)
Time frame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Measured by Sheehan Disability Scale (SDS), a 3 items self-report questionnaire assessing the extent that symptoms have caused the functional impairment in three inter-related domains; work/school, social and family life. The 3 items are measured on a 10 point visual analog scale. A single score of 5 or greater on any of the three scales are associated with significant functional impairment. The 3 items can also be summed into a single dimensional measure of global functional impairment that rages from 0 (unimpaired) to 30 (highly impaired).
Health and disability (Self-report)
Time frame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Measured by World Health Organization - Disability Assessment Schedule (WHODAS) 2.0 a 36-item self-report questionnaire assessing health and disability across six domains: cognition, mobility, self-care, getting along, life activities and participation. The 36 items are rated on a five-point Likert scale. The total score ranges from 0 to 100, higher scores representing greater disability.
Movement assessment (Clinical assessment)
Time frame: Through study completion, a maximum of 12 weeks
Measured by Movement Psychodiagnostic Inventory's (MPI) Action Inventory for Movement Session, an 15-item inventory measuring participation, self-related actions, eye contact, orientation, movement changes, types of interaction, torso/limb configurations while moving. (range: 0-2; higher scores reflect less action (higher severity in movement))
5 secondary outcomes
Patient Perception of Change (Self-report)
Time frame: post-treatment, week 12 time point
Psychosocial Illness Impact (Self-report)
Time frame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Affect (Self-report)
Time frame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Clinical Global Impression - Severity of Illness (Clinical assessment)
Time frame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Clinical Global Impression - Global Improvement (Clinical assessment)
Time frame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- 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.
Joke Bradt, PhD principal investigator
Drexel University
Karolina Bryl, PhD principal investigator
Drexel Unviersity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance/movement therapy (eMove) in people with Schizophrenia and Schizoaffective Disorder, run by Drexel University at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 6 Feb 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (time frame: Baseline). The study lists 13 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 6 Feb 2023.