PsychosisNCT05042050
Attachment-focused iMAgery Therapy for PSychosis (A-iMAPS)
A study testing A-iMAPS in people with Psychosis and Psychosis-Related PTSD, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The relationships we have in childhood affect how we relate to others across our life, including how safe or secure we feel. If our caregivers do not meet our needs well enough in childhood, this can lead to an 'insecure attachment style'. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosis, Psychosis-Related PTSD
- What is being tested?
- A-iMAPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Apr 2022to 23 Nov 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Is currently receiving care under an NHS Community Mental Health Team, and meets ICD-10 or ICD-11 criteria for a schizophrenia-spectrum diagnosis (schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder or psychotic disorder not otherwise specified) indicated by case notes, or under the care of an Early Intervention in Psychosis Service
- Aged 16 or above
- Medication stable for ≥ one month, as indicated by their Care Coordinator
- Has capacity to give written, informed consent
- Proficient in English to complete study questionnaires
- A score of one or more on the four psychosis-related trauma items (items 15 to 18) on the Trauma and Life Events Checklist (Carr et al., 2018b)
Who cannot join
- Has an acquired brain injury
- Has a history of substance misuse that is judged to be the acute cause of the psychotic experiences
- Currently experiencing an acute episode requiring inpatient care
- Currently undertaking psychological therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attachment-focused iMAgery Therapy for PSychosis (A-iMAPS): a Case Series
The relationships we have in childhood affect how we relate to others across our life, including how safe or secure we feel. If our caregivers do not meet our needs well enough in childhood, this can lead to an 'insecure attachment style'. This means we may push others away or cling to them, but never feel fully safe or secure with them. This style is common in people who have mental health problems. This includes psychosis, when people have unusual experiences such as hearing voices others cannot hear. A lot of people with psychosis have difficult experiences with mental health services. This includes involuntary treatments, traumatic interactions and hospital stays, where they may think staff are trying to harm rather than help them. As a result they may not feel safe working with staff and they might re-experience the negative memories of these events. This is known as psychosis-related Post-Traumatic Stress Disorder (PR-PTSD) and can lead to ongoing problems.
Imagery is often defined as mental pictures but it includes imagining our senses (smell, touch, taste) too. It can be a useful therapy tool to help people to work with difficult memories and can help them to feel more safe and secure. Research shows that this is helpful for people with psychosis and people who have been through trauma. Hence, it may be helpful for people with PR-PTSD. The study aims to see if it is viable to do a 6-session therapy using imagery to target PR-PTSD memories. The study will use a case series design where up to 12 people with psychosis will be able to try the therapy. They will be asked to complete questionnaires to understand any potential benefits of the therapy. The findings could inform the research and allow for further development of therapies in this area.
Read the detailed description
Attachment theory underpins human interpersonal experience: it suggests that our early relationships, typically those with our primary caregivers in infancy, have a profound effect on how we learn to relate to the others across the lifespan. Attachment styles in adulthood, particularly insecure styles, have been associated with mental health problems, and it has been noted that improving attachment security can improve mental health.
In the last decade, there has been an increase in research around the role of attachment in psychosis, with an over-representation of insecure attachment patterns seen in individuals with such diagnoses (76% in psychosis compared to 38% in non-clinical samples). A number of studies have identified links with insecure attachment in several aspects of psychopathology, including voice-hearing, persecutory delusions, social functioning and negative symptoms, though the mechanisms between such remain poorly understood.
Attachment insecurity is significantly associated with paranoia and recent research has focused on reducing this using the concept of "felt security", which is defined as "a sense of interpersonal safety associated with secure, protective relationships". In childhood, this sense of safety and security constitutes a 'secure base' from which the child is able to explore. Priming felt security through imagery (i.e. undertaking an imagery exercise focused on secure attachment with another individual in the image) has been found to reduce paranoia in non-clinical adult samples. Moreover, 'felt security' imagery has been deemed effective in engendering a sense of security and reducing paranoia prior to rescripting trauma memories with an individual with psychosis.
Imagery interventions have been long established for use as part of therapy for individuals with psychosis, and have been recognised as a frontier in therapeutic intervention across disorders, including working with negative imagery (e.g., imagery rescripting) and positive imagery. A case series was completed and subsequently a protocol published for a six-session imagery intervention, iMAgery focused psychological therapy for persecutory delusions in PSychosis (iMAPS), targeting intrusive mental imagery and negative beliefs about self and others in psychosis with a combination of negative and positive imagery techniques, which indicated feasibility of combining various imagery techniques in a short intervention for psychosis.
Individuals with psychosis may not only experience intrusive images as a component of their psychotic symptomology, but also as a consequence of their psychosis itself. Psychosis-Related Post-Traumatic Stress Disorder (PR-PTSD) is an under-researched area but a recent review suggested that between 14% and 47% of individuals with psychosis may have PR-PTSD, with associated factors including symptomology of psychosis, treatment factors (involuntary admissions, traumatic inpatient events, restraint) and attachment style. However, there appears to be minimal published literature on this beyond first-episode psychosis. Anxiety in attachment relationships has been identified as positively correlated with psychosis-related and hospital-related PTSD symptoms.
The present study aims to add to the limited literature on PR-PTSD by evaluating the feasibility of a short six-session attachment-focused imagery intervention for psychosis, based upon the iMAPS protocol, which will be adapted to include 'felt security' imagery and the imagery rescripting will focus on psychosis-related trauma. It is anticipated that this would reduce PTSD symptomology. Moreover, by using attachment security primes in conjunction with rescripting, paranoia may also be reduced.
- Conditions
- Psychosis, Psychosis-Related PTSD
- Being tested
- A-iMAPS
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-iMAPSBehavioural
Imagery therapy targeting Psychosis-Related PTSD
| Study group | Role | What they receive |
|---|---|---|
| A-iMAPS Intervention | Experimental | Participants will receive six sessions of Attachment-focused iMAgery therapy for PSychosis. They will be randomised to different baseline lengths (two to five assessment sessions) Receives: Behavioral: A-iMAPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants approached and recruited to the intervention
Measured: Throughout recruitment phase of the study, an average of 24 weeks
Number of sessions attended
Calculated as a percentage
Measured: Throughout the study, attendance recorded for each intervention session, an average of 1 year
Number of participants who drop out of the intervention
Including the point at which they drop out
Measured: For the duration of the study, an average of 1 year
Number of Adverse Events and Serious Adverts Events recorded during the study
Measured: For the duration of the study, an average of 1 year
Secondary outcomes (6)
The suitability of outcome measures used, determined by the number completed
Calculated as a percentage, outcome measures completed weekly
Measured: For the duration of the study, an average of 1 year
Change from baseline in PTSD score
Measured by the PTSD checklist for DSM-5, scored 0 to 80, higher score suggesting worsening symptoms. Once a week from baseline to end of therapy assessment
Measured: For duration of intervention, up to 12 weeks
Change from baseline in paranoia score
Measured using the Revised Green Paranoid Thoughts Scale, scored 0 to 40, higher score suggests worsening symptomology. Once at initial baseline appointment and once at end of therapy assessment
Measured: For duration of intervention, up to 12 weeks
Change from baseline in core schemas
Measured using the Brief Core Schema Scale, scored 0 to 24 on four scales (positive-self, negative-self, positive-others, negative-others), higher score on positive scales suggests improvements, higher score on negative scales suggests worsening. Once at initial baseline appointment and once at end of therapy assessment
Measured: For duration of intervention, up to 12 weeks
Change from baseline in attachment style
Measured using the Revised Psychosis Attachment Measure to determine if style changes. Once at initial baseline appointment and once at end of therapy assessment
Measured: For duration of intervention, up to 12 weeks
Change from baseline in felt security
Measured using an adapted version of the Felt Security Scale, scored 6 to 36, higher score indicates higher levels of felt security. Weekly at each baseline assessment, twice in each therapy session (pre and post attachment prime), and one final at end of therapy assessment
Measured: For duration of intervention, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start27 Apr 2022
- Primary completion16 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proof of Concept Case Series Design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Pennine Care NHS Foundation Trust, Greater Manchester Mental Health NHS Foundation Trust
- Responsible party
- Principal investigator, Nicola Airey, University of Manchester
- Investigators
- Katherine Berry, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042050
- Sponsor's protocol ID
- NHS001888
- Status last verified
- Nov 2022
- First submitted
- 31 Aug 2021
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregated anonymised participant data
Publications
Mikulincer M, Shaver PR. An attachment perspective on psychopathology. World Psychiatry. 2012 Feb;11(1):11-5. doi: 10.1016/j.wpsyc.2012.01.003.
PubMed 22294997Carr SC, Hardy A, Fornells-Ambrojo M. Relationship between attachment style and symptom severity across the psychosis spectrum: A meta-analysis. Clin Psychol Rev. 2018 Feb;59:145-158. doi: 10.1016/j.cpr.2017.12.001. Epub 2017 Dec 6.
PubMed 29229220Lavin R, Bucci S, Varese F, Berry K. The relationship between insecure attachment and paranoia in psychosis: A systematic literature review. Br J Clin Psychol. 2020 Mar;59(1):39-65. doi: 10.1111/bjc.12231. Epub 2019 Aug 7.
PubMed 31390076Bullock G, Newman-Taylor K, Stopa L. The role of mental imagery in non-clinical paranoia. J Behav Ther Exp Psychiatry. 2016 Mar;50:264-8. doi: 10.1016/j.jbtep.2015.10.002. Epub 2015 Oct 8.
PubMed 26492591Pitfield C, Maguire T, Newman-Taylor K. Impact of attachment imagery on paranoia and mood: evidence from two single case studies. Behav Cogn Psychother. 2020 Sep;48(5):572-583. doi: 10.1017/S1352465820000351. Epub 2020 Jun 29.
PubMed 32594948Morrison AP. The use of imagery in cognitive therapy for psychosis: a case example. Memory. 2004 Jul;12(4):517-24. doi: 10.1080/09658210444000142.
PubMed 15487547Holmes EA, Mathews A, Dalgleish T, Mackintosh B. Positive interpretation training: effects of mental imagery versus verbal training on positive mood. Behav Ther. 2006 Sep;37(3):237-47. doi: 10.1016/j.beth.2006.02.002. Epub 2006 May 24.
PubMed 16942975Taylor CDJ, Bee PE, Kelly J, Emsley R, Haddock G. iMAgery focused psychological therapy for persecutory delusions in PSychosis (iMAPS): a multiple baseline experimental case series. Behav Cogn Psychother. 2020 Sep;48(5):530-545. doi: 10.1017/S1352465820000168. Epub 2020 Apr 8.
PubMed 32264985Buswell G, Haime Z, Lloyd-Evans B, Billings J. A systematic review of PTSD to the experience of psychosis: prevalence and associated factors. BMC Psychiatry. 2021 Jan 7;21(1):9. doi: 10.1186/s12888-020-02999-x.
PubMed 33413179
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attachment-focused iMAgery Therapy for PSychosis (A-iMAPS): a Case Series
- ClinicalTrials.gov ID
- NCT05042050
- Acronym / sponsor ID
- NHS001888
- Conditions
- Psychosis, Psychosis-Related PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Pennine Care NHS Foundation Trust, Greater Manchester Mental Health NHS Foundation Trust
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 13 Sep 2021 (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 relationships we have in childhood affect how we relate to others across our life, including how safe or secure we feel. If our caregivers do not meet our needs well enough in childhood, this can lead to an 'insecure attachment style'. This means we may push others away or cling to them, but never feel fully safe or secure with them. This style is common in people who have mental health problems. This includes psychosis, when people have unusual experiences such as hearing voices others cannot hear. A lot of people with psychosis have difficult experiences with mental health services. This includes involuntary treatments, traumatic interactions and hospital stays, where they may think staff are trying to harm rather than help them. As a result they may not feel safe working with staff and they might re-experience the negative memories of these events. This is known as psychosis-related Post-Traumatic Stress Disorder (PR-PTSD) and can lead to ongoing problems.
Imagery is often defined as mental pictures but it includes imagining our senses (smell, touch, taste) too. It can be a useful therapy tool to help people to work with difficult memories and can help them to feel more safe and secure. Research shows that this is helpful for people with psychosis and people who have been through trauma. Hence, it may be helpful for people with PR-PTSD. The study aims to see if it is viable to do a 6-session therapy using imagery to target PR-PTSD memories. The study will use a case series design where up to 12 people with psychosis will be able to try the therapy. They will be asked to complete questionnaires to understand any potential benefits of the therapy. The findings could inform the research and allow for further development of therapies in this area.
Detailed description
Attachment theory underpins human interpersonal experience: it suggests that our early relationships, typically those with our primary caregivers in infancy, have a profound effect on how we learn to relate to the others across the lifespan. Attachment styles in adulthood, particularly insecure styles, have been associated with mental health problems, and it has been noted that improving attachment security can improve mental health.
In the last decade, there has been an increase in research around the role of attachment in psychosis, with an over-representation of insecure attachment patterns seen in individuals with such diagnoses (76% in psychosis compared to 38% in non-clinical samples). A number of studies have identified links with insecure attachment in several aspects of psychopathology, including voice-hearing, persecutory delusions, social functioning and negative symptoms, though the mechanisms between such remain poorly understood.
Attachment insecurity is significantly associated with paranoia and recent research has focused on reducing this using the concept of "felt security", which is defined as "a sense of interpersonal safety associated with secure, protective relationships". In childhood, this sense of safety and security constitutes a 'secure base' from which the child is able to explore. Priming felt security through imagery (i.e. undertaking an imagery exercise focused on secure attachment with another individual in the image) has been found to reduce paranoia in non-clinical adult samples. Moreover, 'felt security' imagery has been deemed effective in engendering a sense of security and reducing paranoia prior to rescripting trauma memories with an individual with psychosis.
Imagery interventions have been long established for use as part of therapy for individuals with psychosis, and have been recognised as a frontier in therapeutic intervention across disorders, including working with negative imagery (e.g., imagery rescripting) and positive imagery. A case series was completed and subsequently a protocol published for a six-session imagery intervention, iMAgery focused psychological therapy for persecutory delusions in PSychosis (iMAPS), targeting intrusive mental imagery and negative beliefs about self and others in psychosis with a combination of negative and positive imagery techniques, which indicated feasibility of combining various imagery techniques in a short intervention for psychosis.
Individuals with psychosis may not only experience intrusive images as a component of their psychotic symptomology, but also as a consequence of their psychosis itself. Psychosis-Related Post-Traumatic Stress Disorder (PR-PTSD) is an under-researched area but a recent review suggested that between 14% and 47% of individuals with psychosis may have PR-PTSD, with associated factors including symptomology of psychosis, treatment factors (involuntary admissions, traumatic inpatient events, restraint) and attachment style. However, there appears to be minimal published literature on this beyond first-episode psychosis. Anxiety in attachment relationships has been identified as positively correlated with psychosis-related and hospital-related PTSD symptoms.
The present study aims to add to the limited literature on PR-PTSD by evaluating the feasibility of a short six-session attachment-focused imagery intervention for psychosis, based upon the iMAPS protocol, which will be adapted to include 'felt security' imagery and the imagery rescripting will focus on psychosis-related trauma. It is anticipated that this would reduce PTSD symptomology. Moreover, by using attachment security primes in conjunction with rescripting, paranoia may also be reduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof of Concept Case Series Design
| Arm | Type | Receives |
|---|---|---|
| A-iMAPS Intervention | Experimental | Behavioral: A-iMAPSParticipants will receive six sessions of Attachment-focused iMAgery therapy for PSychosis. They will be randomised to different baseline lengths (two to five assessment sessions) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Is currently receiving care under an NHS Community Mental Health Team, and meets ICD-10 or ICD-11 criteria for a schizophrenia-spectrum diagnosis (schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder or psychotic disorder not otherwise specified) indicated by case notes, or under the care of an Early Intervention in Psychosis Service
- Aged 16 or above
- Medication stable for ≥ one month, as indicated by their Care Coordinator
- Has capacity to give written, informed consent
- Proficient in English to complete study questionnaires
Key exclusion criteria (4 listed)
- Has an acquired brain injury
- Has a history of substance misuse that is judged to be the acute cause of the psychotic experiences
- Currently experiencing an acute episode requiring inpatient care
- Currently undertaking psychological therapy
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 |
|---|---|---|
| A-iMAPSImagery therapy targeting Psychosis-Related PTSD | Behavioural | A-iMAPS Intervention |
Primary outcome
Number of participants approached and recruited to the intervention
Time frame: Throughout recruitment phase of the study, an average of 24 weeks
Number of sessions attended
Time frame: Throughout the study, attendance recorded for each intervention session, an average of 1 year
Calculated as a percentage
Number of participants who drop out of the intervention
Time frame: For the duration of the study, an average of 1 year
Including the point at which they drop out
Number of Adverse Events and Serious Adverts Events recorded during the study
Time frame: For the duration of the study, an average of 1 year
6 secondary outcomes
The suitability of outcome measures used, determined by the number completed
Time frame: For the duration of the study, an average of 1 year
Change from baseline in PTSD score
Time frame: For duration of intervention, up to 12 weeks
Change from baseline in paranoia score
Time frame: For duration of intervention, up to 12 weeks
Change from baseline in core schemas
Time frame: For duration of intervention, up to 12 weeks
Change from baseline in attachment style
Time frame: For duration of intervention, up to 12 weeks
Change from baseline in felt security
Time frame: For duration of intervention, up to 12 weeks
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 28 Nov 2022.
- Background: PubMed 22294997Mikulincer M, Shaver PR. An attachment perspective on psychopathology. World Psychiatry. 2012 Feb;11(1):11-5. doi: 10.1016/j.wpsyc.2012.01.003.
- Background: PubMed 29229220Carr SC, Hardy A, Fornells-Ambrojo M. Relationship between attachment style and symptom severity across the psychosis spectrum: A meta-analysis. Clin Psychol Rev. 2018 Feb;59:145-158. doi: 10.1016/j.cpr.2017.12.001. Epub 2017 Dec 6.
- Background: PubMed 31390076Lavin R, Bucci S, Varese F, Berry K. The relationship between insecure attachment and paranoia in psychosis: A systematic literature review. Br J Clin Psychol. 2020 Mar;59(1):39-65. doi: 10.1111/bjc.12231. Epub 2019 Aug 7.
- Background: PubMed 26492591Bullock G, Newman-Taylor K, Stopa L. The role of mental imagery in non-clinical paranoia. J Behav Ther Exp Psychiatry. 2016 Mar;50:264-8. doi: 10.1016/j.jbtep.2015.10.002. Epub 2015 Oct 8.
- Background: PubMed 32594948Pitfield C, Maguire T, Newman-Taylor K. Impact of attachment imagery on paranoia and mood: evidence from two single case studies. Behav Cogn Psychother. 2020 Sep;48(5):572-583. doi: 10.1017/S1352465820000351. Epub 2020 Jun 29.
- Background: PubMed 15487547Morrison AP. The use of imagery in cognitive therapy for psychosis: a case example. Memory. 2004 Jul;12(4):517-24. doi: 10.1080/09658210444000142.
- Background: PubMed 16942975Holmes EA, Mathews A, Dalgleish T, Mackintosh B. Positive interpretation training: effects of mental imagery versus verbal training on positive mood. Behav Ther. 2006 Sep;37(3):237-47. doi: 10.1016/j.beth.2006.02.002. Epub 2006 May 24.
- Background: PubMed 32264985Taylor CDJ, Bee PE, Kelly J, Emsley R, Haddock G. iMAgery focused psychological therapy for persecutory delusions in PSychosis (iMAPS): a multiple baseline experimental case series. Behav Cogn Psychother. 2020 Sep;48(5):530-545. doi: 10.1017/S1352465820000168. Epub 2020 Apr 8.
- Background: PubMed 33413179Buswell G, Haime Z, Lloyd-Evans B, Billings J. A systematic review of PTSD to the experience of psychosis: prevalence and associated factors. BMC Psychiatry. 2021 Jan 7;21(1):9. doi: 10.1186/s12888-020-02999-x.
- Individual participant dataSharing planned: No. Aggregated anonymised participant data
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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.
Katherine Berry, PhD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-iMAPS in people with Psychosis and Psychosis-Related PTSD, run by University of Manchester at 1 site in United Kingdom.
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 4 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 28 Nov 2022. 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 Kingdom. 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?
Number of participants approached and recruited to the intervention (time frame: Throughout recruitment phase of the study, an average of 24 weeks). The study lists 4 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 NCT05042050, which also lists 9 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 28 Nov 2022.