Psychotic DisordersSocialNCT03217955
Cognitive Behavioural Therapy- Social Functioning In Adolescence With Recent Onset Schizophrenia
A study testing CBT-SA and Standard Treatment in people with Psychotic Disorders, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
Rationale: There is growing consensus that targeting negative symptoms such as social withdrawal is essential to be able to preserve social participation, thereby reducing the high yearly costs of schizophrenia. Aaron T. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- CBT-SA and Standard Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2014to 1 Mar 2017
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- recent onset schizophrenia or related disorder (start antipsychotic medication <2 yr);
- Social withdrawal (> 3 moderate severity on the PANSS N4; Passive/apathic social withdrawal; range 0-7);
- Aged 18-35 years;
- Fluent in Dutch
- IQ>70;
- Able and willing to give informed consent
Who cannot join
- Younger than eighteen years of age;
- No mastery of the Dutch language;
- Negative symptoms as a consequence of positive symptoms (e.g. withdrawal due to paranoid delusions). Positive symptoms as such are not an exclusion criterion; only when they are considered to be the primary cause of the negative symptoms, in which case CBT focused on positive symptoms or another type of intervention for positive symptoms is called for.
About this study
Rationale: There is growing consensus that targeting negative symptoms such as social withdrawal is essential to be able to preserve social participation, thereby reducing the high yearly costs of schizophrenia. Aaron T. Beck, founder of Cognitive Behavioural Therapy (CBT), and colleagues have developed and investigated a new CBT approach, in which they target inactivity in a chronic schizophrenia population with severe negative symptoms The therapy is based on accumulating evidence that dysfunctional beliefs in conjunction with neurocognitive impairments can impede social functioning. These results suggest that CBT can be highly successful in establishing clinically meaningful improvements. However, the therapy has not yet been investigated in a recent-onset population.
Objective: To evaluate the applicability and (cost-) effectiveness of a shortened, partly group based, Cognitive Behavioural Therapy focussing on social activation (CBTsa) in patients with recent onset schizophrenia.
Read more
Hypotheses: 1) the investigators hypothesized that CBT focused on social activation (CBTsa) in a recent-onset population will result in a substantial reduction in severity of negative symptoms, in particular social withdrawal.
- The investigators expected that CBTsa would lead to an improvement in terms of Quality of Life and overall functioning.
- The investigators expected this intervention to result in a reduction in need for care and QALY gain as a consequence of improvement in symptoms and social functioning.
Study design: Single blind randomized controlled trial with 6 month-follow up. Study population: Patients between 18 and 35 years old with negative symptoms of at least moderate severity, and who have been recently (< 2yrs) diagnosed with schizophrenia.
Intervention (if applicable): Individual and group-based CBT intervention targeting social withdrawal.
Main study parameters/endpoints: Change in negative symptoms, Social functioning, and quality of life, Productivity losses.
Read the detailed description
There is growing consensus that targeting negative symptoms such as social withdrawal is essential to be able to preserve social participation; thereby reducing the high yearly costs of schizophrenia.
Aaron T. Beck, founder of Cognitive Behavioural Therapy (CBT), and colleagues have developed and investigated a new CBT approach, in which they target inactivity in a chronic schizophrenia population with severe negative symptoms; a subgroup that has always believed to be highly treatment resistant. The therapy is based on accumulating evidence that dysfunctional beliefs in conjunction with neurocognitive impairments can impede functioning. Its primary focus is to help patients overcome isolation and inactivity, thereby improve quality of life, rather than primarily focussing on the reduction of psychotic symptoms. Grant, Beck and colleagues found that patients treated with CBT not only showed more improvement in global functioning than patients in the Standard Treatment condition, they also showed a greater reduction in avolition/apathy and psychotic symptoms. These results suggest that CBT can be highly successful in establishing clinically meaningful improvements.
Thus far, this intervention had only been investigated in patients with chronic schizophrenia although there is increasing evidence that social withdrawal is also prominent in the early phase of the illness. Moreover, there is growing consensus that early intervention is more effective in improving illness course than intervention at a later stage of the illness.
In the present study the investigators aimed to examine whether a relatively short, partly group based CBT targeting negative symptoms in recent-onset schizophrenia patients results in reduced social withdrawal, need for care and improvement in quality of life and in overall functioning compared to treatment as usual.
Primary Objective:
The primary aim of this project was to examine a shortened (+/- 20 sessions) and partly group-based version of the new and promising CBT approach tested in a chronic population (from now: 'Cognitive Behavioural Therapy - Social Activation' (CBTsa)), for its applicability and effectiveness in a recent-onset population. The CBTsa has been adjusted to the specific needs of the young recent-onset cohort.
Secondary Objective(s):
A secondary aim was explore the cost-effectiveness of this new intervention (i.e. the balance between costs and health outcomes for CBTsa compared with treatment as usual(ST).
Hypotheses:
- CBT focused on social activation (CBTsa) will result in a substantial reduction in severity of negative symptoms, and in particular social withdrawal
- The intervention will result in a reduction in need for care and QALY gain as a consequence of improvement in symptoms and social functioning.
- CBTsa will lead to an improvement in terms of Quality of Life and overall functioning and symptomatology.
Study Design The present study entails a single-blind two-level RCT directed at patients with recent onset schizophrenia. Participants will be randomly assigned to intervention condition (Cognitive Behavioral Therapy- Social Activation (CBTsa) plus Standard Treatment (ST)), or to the control condition (ST alone). Patients will be stratified by sex, as females with recent onset schizophrenia have a better prognosis and may respond differentially to CBTsa. A baseline test battery will be employed to examine causes of social withdrawal and interaction with treatment outcome. Follow-up assessments (repetition test battery) will take place directly after the intervention period and 6 months post-treatment.
Study population/ datasources Study sample: patients hospitalized or attending day-treatment or receiving outpatient care at one of the participating centers. To maximize engagement, group therapy will be incorporated in the day program. Individual therapy sessions will be delivered flexibly (time, location). All participants are embedded within a low-threshold intensive outreaching care system (aligned with our academic department).
- Conditions
- Psychotic Disorders
- Being tested
- CBT-SA, Standard Treatment
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-SABehavioural
Info has been included in arm description
Standard TreatmentBehavioural
Info has been included in arm description
| Study group | Role | What they receive |
|---|---|---|
| CBT-SA | Experimental | 1. Group sessions for 4 weeks, two sessions per week, 60 minutes per session, two trainers (a CBT therapist and a CBT assistant); eight participants, and;
2. Individual sessions (crystallizing learned skills, focus on individual needs) during 6-8 weeks, one session per week, 45 minutes per session Receives: Behavioral: CBT-SA; Behavioral: Standard Treatment |
| Standard Treatment | Active comparator | Participants in both study conditions will receive ST. Participants are hospitalized or attending day-treatment at the Department of Early Psychosis, Amsterdam, the psychosis department of the ABC team, Utrecht, Parnassia Den Haag and collaborating (local community) mental health centers. Receives: Behavioral: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of social engagement
Level of social engagement as measured by experiences sampling method
Measured: 3 months (at study completion)
Negative symptoms
Negative symptoms as measured with PANSS
Measured: 3 months (at study completion)
Negative symptoms
Negative symptoms as measured with BNSS
Measured: 3 months (at study completion)
Secondary outcomes (7)
Quality of Life
Assessed with the AQoL
Measured: 3 months (at study completion)
Global functioning
Assessed with the GAF
Measured: 3 months (at study completion)
Productivity losses
Effects on ability to perform paid and unpaid work
Measured: 3 months (at study completion)
Positive and General Symptomatology
As assessed with the PANSS
Measured: 3 months (at study completion)
Depression
Depression as assessed with the Calgary Depression Scale for Schizophrenia
Measured: 3 months (at study completion)
Inhibition/ Activation
Behavioural Inhibition/ Behavioural Activation Scales (BISBAS)
Measured: 3 months (at study completion)
Need for care
Camberwell Assessment of Need
Measured: 3 months (at study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start6 May 2014
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study entails a single-blind two-level RCT directed at patients with recent onset schizophrenia. Participants are randomly assigned to intervention condition (Cognitive Behavioral Therapy- Social Activation (CBTsa) plus Standard Treatment (ST)), or to the control condition (ST alone). A baseline test battery is employed to examine causes of social withdrawal and interaction with treatment outcome. Follow-up assessments (repetition test battery) will take place directly after the intervention period and 6 months post-treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Arkin, Vroege Psychose ABC - Utrecht, Centrum Eerste Psychose, Utrecht, Netherlands, GGZ inGeest
- Responsible party
- Principal investigator, Lieuwe de Haan, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Lieuwe de Haan, Ph.D., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217955
- Sponsor's protocol ID
- NL46776.018.13
- Acronym
- Social
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Staring AB, Ter Huurne MA, van der Gaag M. Cognitive Behavioral Therapy for negative symptoms (CBT-n) in psychotic disorders: a pilot study. J Behav Ther Exp Psychiatry. 2013 Sep;44(3):300-6. doi: 10.1016/j.jbtep.2013.01.004. Epub 2013 Feb 1.
PubMed 23454550Grant PM, Huh GA, Perivoliotis D, Stolar NM, Beck AT. Randomized trial to evaluate the efficacy of cognitive therapy for low-functioning patients with schizophrenia. Arch Gen Psychiatry. 2012 Feb;69(2):121-7. doi: 10.1001/archgenpsychiatry.2011.129. Epub 2011 Oct 3.
PubMed 21969420Verma S, Subramaniam M, Abdin E, Poon LY, Chong SA. Symptomatic and functional remission in patients with first-episode psychosis. Acta Psychiatr Scand. 2012 Oct;126(4):282-9. doi: 10.1111/j.1600-0447.2012.01883.x. Epub 2012 May 23.
PubMed 22616617Wijnen BFM, Pos K, Velthorst E, Schirmbeck F, Chan HY, de Haan L, van der Gaag M, Evers SMAA, Smit F. Economic evaluation of brief cognitive behavioural therapy for social activation in recent-onset psychosis. PLoS One. 2018 Nov 12;13(11):e0206236. doi: 10.1371/journal.pone.0206236. eCollection 2018.
PubMed 30419038
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy- Social Functioning In Adolescence With Recent Onset Schizophrenia
- ClinicalTrials.gov ID
- NCT03217955
- Acronym / sponsor ID
- Social / NL46776.018.13
- Conditions
- Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Arkin, Vroege Psychose ABC - Utrecht, Centrum Eerste Psychose, Utrecht, Netherlands, GGZ inGeest
- Study start
- 6 May 2014 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 14 Jul 2017 (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.
Rationale: There is growing consensus that targeting negative symptoms such as social withdrawal is essential to be able to preserve social participation, thereby reducing the high yearly costs of schizophrenia. Aaron T. Beck, founder of Cognitive Behavioural Therapy (CBT), and colleagues have developed and investigated a new CBT approach, in which they target inactivity in a chronic schizophrenia population with severe negative symptoms The therapy is based on accumulating evidence that dysfunctional beliefs in conjunction with neurocognitive impairments can impede social functioning. These results suggest that CBT can be highly successful in establishing clinically meaningful improvements. However, the therapy has not yet been investigated in a recent-onset population.
Objective: To evaluate the applicability and (cost-) effectiveness of a shortened, partly group based, Cognitive Behavioural Therapy focussing on social activation (CBTsa) in patients with recent onset schizophrenia.
Hypotheses: 1) the investigators hypothesized that CBT focused on social activation (CBTsa) in a recent-onset population will result in a substantial reduction in severity of negative symptoms, in particular social withdrawal.
- The investigators expected that CBTsa would lead to an improvement in terms of Quality of Life and overall functioning.
- The investigators expected this intervention to result in a reduction in need for care and QALY gain as a consequence of improvement in symptoms and social functioning.
Study design: Single blind randomized controlled trial with 6 month-follow up. Study population: Patients between 18 and 35 years old with negative symptoms of at least moderate severity, and who have been recently (< 2yrs) diagnosed with schizophrenia.
Intervention (if applicable): Individual and group-based CBT intervention targeting social withdrawal.
Main study parameters/endpoints: Change in negative symptoms, Social functioning, and quality of life, Productivity losses.
Detailed description
There is growing consensus that targeting negative symptoms such as social withdrawal is essential to be able to preserve social participation; thereby reducing the high yearly costs of schizophrenia.
Aaron T. Beck, founder of Cognitive Behavioural Therapy (CBT), and colleagues have developed and investigated a new CBT approach, in which they target inactivity in a chronic schizophrenia population with severe negative symptoms; a subgroup that has always believed to be highly treatment resistant. The therapy is based on accumulating evidence that dysfunctional beliefs in conjunction with neurocognitive impairments can impede functioning. Its primary focus is to help patients overcome isolation and inactivity, thereby improve quality of life, rather than primarily focussing on the reduction of psychotic symptoms. Grant, Beck and colleagues found that patients treated with CBT not only showed more improvement in global functioning than patients in the Standard Treatment condition, they also showed a greater reduction in avolition/apathy and psychotic symptoms. These results suggest that CBT can be highly successful in establishing clinically meaningful improvements.
Thus far, this intervention had only been investigated in patients with chronic schizophrenia although there is increasing evidence that social withdrawal is also prominent in the early phase of the illness. Moreover, there is growing consensus that early intervention is more effective in improving illness course than intervention at a later stage of the illness.
In the present study the investigators aimed to examine whether a relatively short, partly group based CBT targeting negative symptoms in recent-onset schizophrenia patients results in reduced social withdrawal, need for care and improvement in quality of life and in overall functioning compared to treatment as usual.
Primary Objective:
The primary aim of this project was to examine a shortened (+/- 20 sessions) and partly group-based version of the new and promising CBT approach tested in a chronic population (from now: 'Cognitive Behavioural Therapy - Social Activation' (CBTsa)), for its applicability and effectiveness in a recent-onset population. The CBTsa has been adjusted to the specific needs of the young recent-onset cohort.
Secondary Objective(s):
A secondary aim was explore the cost-effectiveness of this new intervention (i.e. the balance between costs and health outcomes for CBTsa compared with treatment as usual(ST).
Hypotheses:
- CBT focused on social activation (CBTsa) will result in a substantial reduction in severity of negative symptoms, and in particular social withdrawal
- The intervention will result in a reduction in need for care and QALY gain as a consequence of improvement in symptoms and social functioning.
- CBTsa will lead to an improvement in terms of Quality of Life and overall functioning and symptomatology.
Study Design The present study entails a single-blind two-level RCT directed at patients with recent onset schizophrenia. Participants will be randomly assigned to intervention condition (Cognitive Behavioral Therapy- Social Activation (CBTsa) plus Standard Treatment (ST)), or to the control condition (ST alone). Patients will be stratified by sex, as females with recent onset schizophrenia have a better prognosis and may respond differentially to CBTsa. A baseline test battery will be employed to examine causes of social withdrawal and interaction with treatment outcome. Follow-up assessments (repetition test battery) will take place directly after the intervention period and 6 months post-treatment.
Study population/ datasources Study sample: patients hospitalized or attending day-treatment or receiving outpatient care at one of the participating centers. To maximize engagement, group therapy will be incorporated in the day program. Individual therapy sessions will be delivered flexibly (time, location). All participants are embedded within a low-threshold intensive outreaching care system (aligned with our academic department).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study entails a single-blind two-level RCT directed at patients with recent onset schizophrenia. Participants are randomly assigned to intervention condition (Cognitive Behavioral Therapy- Social Activation (CBTsa) plus Standard Treatment (ST)), or to the control condition (ST alone). A baseline test battery is employed to examine causes of social withdrawal and interaction with treatment outcome. Follow-up assessments (repetition test battery) will take place directly after the intervention period and 6 months post-treatment.
| Arm | Type | Receives |
|---|---|---|
| CBT-SA | Experimental | Behavioral: CBT-SA, Behavioral: Standard Treatment1. Group sessions for 4 weeks, two sessions per week, 60 minutes per session, two trainers (a CBT therapist and a CBT assistant); eight participants, and; 2. Individual sessions (crystallizing learned skills, focus on individual needs) during 6-8 weeks, one session per week, 45 minutes per session |
| Standard Treatment | Active comparator | Behavioral: Standard TreatmentParticipants in both study conditions will receive ST. Participants are hospitalized or attending day-treatment at the Department of Early Psychosis, Amsterdam, the psychosis department of the ABC team, Utrecht, Parnassia Den Haag and collaborating (local community) mental health centers. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- recent onset schizophrenia or related disorder (start antipsychotic medication <2 yr);
- Social withdrawal (> 3 moderate severity on the PANSS N4; Passive/apathic social withdrawal; range 0-7);
- Aged 18-35 years;
- Fluent in Dutch
- IQ>70;
Key exclusion criteria (3 listed)
- Younger than eighteen years of age;
- No mastery of the Dutch language;
- Negative symptoms as a consequence of positive symptoms (e.g. withdrawal due to paranoid delusions). Positive symptoms as such are not an exclusion criterion; only when they are considered to be the primary cause of the negative symptoms, in which case CBT focused on positive symptoms or another type of intervention for positive symptoms is called for.
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 |
|---|---|---|
| CBT-SAInfo has been included in arm description | Behavioural | CBT-SA |
| Standard TreatmentInfo has been included in arm description | Behavioural | CBT-SA, Standard Treatment |
Primary outcome
Level of social engagement
Time frame: 3 months (at study completion)
Level of social engagement as measured by experiences sampling method
Negative symptoms
Time frame: 3 months (at study completion)
Negative symptoms as measured with PANSS
Negative symptoms
Time frame: 3 months (at study completion)
Negative symptoms as measured with BNSS
7 secondary outcomes
Quality of Life
Time frame: 3 months (at study completion)
Global functioning
Time frame: 3 months (at study completion)
Productivity losses
Time frame: 3 months (at study completion)
Positive and General Symptomatology
Time frame: 3 months (at study completion)
Depression
Time frame: 3 months (at study completion)
Inhibition/ Activation
Time frame: 3 months (at study completion)
Need for care
Time frame: 3 months (at study completion)
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 14 Jul 2017.
- Background: PubMed 23454550Staring AB, Ter Huurne MA, van der Gaag M. Cognitive Behavioral Therapy for negative symptoms (CBT-n) in psychotic disorders: a pilot study. J Behav Ther Exp Psychiatry. 2013 Sep;44(3):300-6. doi: 10.1016/j.jbtep.2013.01.004. Epub 2013 Feb 1.
- Background: PubMed 21969420Grant PM, Huh GA, Perivoliotis D, Stolar NM, Beck AT. Randomized trial to evaluate the efficacy of cognitive therapy for low-functioning patients with schizophrenia. Arch Gen Psychiatry. 2012 Feb;69(2):121-7. doi: 10.1001/archgenpsychiatry.2011.129. Epub 2011 Oct 3.
- Background: PubMed 22616617Verma S, Subramaniam M, Abdin E, Poon LY, Chong SA. Symptomatic and functional remission in patients with first-episode psychosis. Acta Psychiatr Scand. 2012 Oct;126(4):282-9. doi: 10.1111/j.1600-0447.2012.01883.x. Epub 2012 May 23.
- Derived from this study: PubMed 30419038Wijnen BFM, Pos K, Velthorst E, Schirmbeck F, Chan HY, de Haan L, van der Gaag M, Evers SMAA, Smit F. Economic evaluation of brief cognitive behavioural therapy for social activation in recent-onset psychosis. PLoS One. 2018 Nov 12;13(11):e0206236. doi: 10.1371/journal.pone.0206236. eCollection 2018.
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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.
Lieuwe de Haan, Ph.D. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Questions about this trial
What is this clinical trial studying?
A study testing CBT-SA and Standard Treatment in people with Psychotic Disorders, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
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 6 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: finished, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Level of social engagement (time frame: 3 months (at study completion)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03217955, which also lists 4 linked publications.
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 14 Jul 2017.