Substance Use DisordersF-CaSTNCT05647863
F-CaST for Individuals With Substance Use Disorder
A study testing Functional Cognitive and Sensory Treatment (F-CaST) in people with Substance Use Disorders, run by Tel Aviv University at 1 site in Israel.
Trial summary
Examining the effectiveness of the F-CaST based on a controlled randomized trial in patients with SUD residing in a therapeutic community. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Functional Cognitive and Sensory Treatment (F-CaST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Nov 2022to 15 Dec 2023
- 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 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed by a psychiatrist and meeting the DSM-V diagnostic criteria for severe SUD
- Admitted to the therapeutic community (TC) for full-length SUD rehabilitation and with no more than 3 previous rehabilitation trials in this TC
- Abstained from drugs and alcohol for at least 14 days (verifying minimum withdrawal effects); and no more than 21 days of TC residency (to ensure familiarization with the facility)
- Without a significant cognitive deficit [the Montreal Cognitive Assessment (MoCA)≥19/30 points) and adequate language skills
Who cannot join
- Relapsing substance use in the TC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Rehabilitation Compliance and Treatment Duration by Treating Executive Function and Sensory Modulation Deficits in Individuals With Substance Use Disorder: A Randomized Control Trial
Examining the effectiveness of the F-CaST based on a controlled randomized trial in patients with SUD residing in a therapeutic community.
Read the detailed description
Background and Aims: Substance use disorder (SUD), an urgent public health concern, is a chronic relapsing brain disorder caused by psychoactive substances, characterized by cognitive, behavioral, and physiological symptoms, severely impacting every life domain. Repeated substance use leads to impairments in higher cognitive abilities, termed executive functions (EF), and leads to SUD chronicity. Furthermore, EF deficits are associated with difficulties in sensory processing, severely limiting daily functions and with reported high incidence in SUD. However, to date both are not addressed therapeutically. This translational study aims to enhance rehabilitation success in patients with SUD residing in a therapeutic community (TC) by employing sensory and EF strategies utilizing the Functional Cognitive and Sensory Treatment (F-CaST), an innovative personalized therapy.
Methods: A qualitative study will be nested in a single-blind, controlled randomized trial, comparing two groups: (i) Experimental group- F-CaST - in which therapy is individually tailored for successful task performance and where the focus is on strategies for improving sensory and EF deficits and (ii) Control group - Standard Care - the typical treatment given in the therapeutic community. Measurement will be conducted by assessors blind to group allocation at 4 time points: T1- pre-intervention; T2- post-intervention; T3- at a 1-month follow-up; and T4- at a 3-month follow-up.
Population: Forty-eight adults diagnosed with SUD, aged 18-45 years, with no significant cognitive deficits, and residing in a TC for SUD.
Tools: Both objective and subjective measures to evaluate TC performance will be applied. Additionally, interviews will be conducted to provide a deeper understanding of the perceived performance and difficulties.
Expected Results: F-CaST will lead to improved rehabilitation success and treatment duration, better compliance with TC requirements, and greater satisfaction, compared to control group.
- Conditions
- Substance Use Disorders
- Being tested
- Functional Cognitive and Sensory Treatment (F-CaST)
- Keywords
- Rehabilitation compliance, Executive functions, Sensory modulation dysfunction
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Cognitive and Sensory Treatment (F-CaST)Other
Also called Cognitive sensory occupational therapy
F-CaST, a client-centered care, is a functional cognitive sensory intervention focusing on improving Executive Function (EF) and sensory modulation impairments using a modification of the Functional and Cognitive Occupational Therapy Treatment.
| Study group | Role | What they receive |
|---|---|---|
| F-CaST | Experimental | The experimental group who will receive the Functional Cognitive and Sensory Treatment (F-CaST)- in which therapy is individually tailored for successful task performance and where the focus is on strategies for improving sensory and EF deficits. Receives: Other: Functional Cognitive and Sensory Treatment (F-CaST) |
| Standard Care | No intervention | Standard care at the therapeutic community for SUD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change The Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure for individuals to identify and prioritize everyday issues that restrict their participation in everyday living.
Participants will define three goals, and rate their current performance \& satisfaction for each goal using a 10-point scale. Higher scores indicate better outcomes.
Measured: Change in The Canadian Occupational Performance Measure between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), to T3 (follow-up- one month later) and T4 (follow-up- three months later). Higher scores indicate better outcomes
Length of stay in Therapeutic Community
Length of stay (days) residing in Therapeutic Community. Longer time spent in the TC is better.
Measured: At T4 ( three months later after follow-up) or earlier (when they leave the TC)
Change in Performance in the Therapeutic Community
Participant performance in the Therapeutic Community will be based on the community counselor's evaluation. Better performance is better
Measured: Change in Performance in the Therapeutic Community between pre (T1-week 0) - to post (T2- post-intervention 8-9 weeks later) to T3 (follow-up- one month later) and T4 (follow-up- three months later).
Change in number of times coming late for scheduled appointments
Number of times coming late for scheduled appointments. Less times of coming late is better.
Measured: Change in number of times coming late for scheduled appointments between pre (T1-week 0) - to post (T2- post-intervention 8-9 weeks later) to T3 (follow-up- one month later) and T4 (follow-up- three months later).
Secondary outcomes (11)
Four Item Tablet Test (4ITT)
Performance test of executive functioning via a quick online shopping task using a tablet.
Scores will include shopping time \& mistakes - less time with less mistakes is better shopping performance.
Measured: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
Color Trails Test (CTT)
A pen and paper neuropsychological test used to measure cognitive flexibility and processing speed. The CTT includes two parts: (1) CTT part 1 requires to connect a series of 25 numbered circles that are scattered on a sheet of paper and (2) CTT part 2 requires to connect numbered circles from 1 to 25 in sequence alternating between two colors-pink and yellow (1-pink, 2-yellow, 3-pink, 4-yellow…). The time (seconds) to complete each part will be recorded. Completion time (up to 240 seconds) translated to standardized score by normative data correcting for age and years of education. The CTT is widely used in a variety of populations and was found as a valid and reliable measure with a variety of populations.
Less time (secs) indicates better executive function.
Measured: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
A 75-item questionnaire assessing EF in everyday environments. BRIEF-A is composed of nine clinical scales which form two indices: (i) the Behavioral Regulations Index (BRI), and (ii) the Metacognition Index (MI). The BRI and MI together produce an overall Global Executive Composite (GEC). Based on the past 30 days, items are graded on a 3-point scale: 'never' (1), 'sometimes' (2), or 'always' (3). The raw scores are converted to T-scores where a score of 65 or higher denotes a clinical deficit. Higher scores indicate worse outcomes.
Measured: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
Computerized cognitive assessment battery (CANTAB)
Two computerized tasks from the Cambridge Automatic Neuropsychological Test Battery (CANTAB) subtests will be used to assess multitasking and working memory.
The tasks will be administered using a touchscreen tablet:
The Multitasking Test (MTT) Spatial Working Memory (SWM)
Measured: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
The Self-Regulation Skills Interview
A semi-structured interview composed of six questions that assess a range of metacognitive skills essential for rehabilitation planning, monitoring an individual's progress, and evaluating the outcome of treatment interventions. The six questions are applied to a main area of difficulty experienced in everyday living as identified by the individual.
Measured: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
The Sensory Responsiveness Questionnaire-Intensity Scale
A 58-item questionnaire aimed at clinically classifying sensory modulation dysfunction in adults. Items represent typical daily life situations involving auditory, visual, gustatory, olfactory, vestibular and somatosensory sensations, excluding pain. Items are phrased either in a hedonic or aversive valence and are graded on a 5-point Likert scale: 'not at all' (1) to 'very much' (5). Two cut-off scores are provided.
Measured: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
The Pain Sensitivity Questionnaire
A 17 item questionnaire aimed to quantify everyday somatosensory pain sensitivity to imagined painful daily life situations. Participants rate the intensity of imagined pain on a 10-point scale: 'not painful at all' (0) to 'the worst pain imaginable' (10). The Pain Sensitivity Questionnaire provides a total score and two sub-scores.
Measured: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
The New General Self-Efficacy Scale
An 8-item measure that assesses how much people believe they can achieve their goals despite their difficulties. Each of the eight statements (e.g. "Even when things are tough, I can perform quite well") are rated using a 5-point rating scale: 'strongly disagree' (1) to 'strongly agree' (5); higher scores indicate higher self-efficacy.
Measured: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
Satisfaction with Life Scale
A self-report questionnaire measuring global life satisfaction. This scale examines the cognitive component of subjective well-being and consists of five statements that reflect the overall satisfaction of an individual's life. Responders are asked to rate the level of agreement with each statement on a scale ranging from 1 (total disagreement) to 7 (total agreement). Higher scores indicate better life satisfaction.
Measured: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
In-depth semi-structured interview
A semi-structured interview, comprising of 5 open-end questions aiming to understand how adults with SUD perceive their performance at the TC and the link between their performance to their executive functioning and sensory modulation disorder. The interview will comprise questions such as What, in your opinion, can explain your performance?
Each time point will be analyzed separately.
Measured: Pre (T1-week 0), T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) - 12 item version
Assesses activity limitations and participation restrictions in daily activities. The WHODAS 2.0 comprises six major life domains yielding the sub-scales: Cognition; Household (life activity); Mobility; Self-care; Social; and Participation in Society. Items are graded on a 5-point Likert scale: "none" (0) to "extreme" (4), where higher scores denote higher disability.
Measured: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start25 Nov 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with an experimental group and a control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tami Bar-Shalita, Tel Aviv University
- Investigators
- Naama Assayag, Dr., Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647863
- Sponsor's protocol ID
- 0001484-4
- Acronym
- F-CaST
- Status last verified
- Apr 2024
- First submitted
- 10 Aug 2022
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon personal request
Publications
Assayag N, Bar-Shalita T, Rand D. The Functional-Cognitive and Sensory Treatment (F-CaST) to improve rehabilitation outcomes of individuals with substance use disorder: a study protocol for a mixed-method randomized controlled trial. Addict Sci Clin Pract. 2024 Apr 9;19(1):28. doi: 10.1186/s13722-024-00449-7.
PubMed 38594737
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Rehabilitation Compliance and Treatment Duration by Treating Executive Function and Sensory Modulation Deficits in Individuals With Substance Use Disorder: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05647863
- Acronym / sponsor ID
- F-CaST / 0001484-4
- Conditions
- Substance Use Disorders
- Keywords
- Rehabilitation compliance, Executive functions, Sensory modulation dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 13 Dec 2022 (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.
Examining the effectiveness of the F-CaST based on a controlled randomized trial in patients with SUD residing in a therapeutic community.
Detailed description
Background and Aims: Substance use disorder (SUD), an urgent public health concern, is a chronic relapsing brain disorder caused by psychoactive substances, characterized by cognitive, behavioral, and physiological symptoms, severely impacting every life domain. Repeated substance use leads to impairments in higher cognitive abilities, termed executive functions (EF), and leads to SUD chronicity. Furthermore, EF deficits are associated with difficulties in sensory processing, severely limiting daily functions and with reported high incidence in SUD. However, to date both are not addressed therapeutically. This translational study aims to enhance rehabilitation success in patients with SUD residing in a therapeutic community (TC) by employing sensory and EF strategies utilizing the Functional Cognitive and Sensory Treatment (F-CaST), an innovative personalized therapy.
Methods: A qualitative study will be nested in a single-blind, controlled randomized trial, comparing two groups: (i) Experimental group- F-CaST - in which therapy is individually tailored for successful task performance and where the focus is on strategies for improving sensory and EF deficits and (ii) Control group - Standard Care - the typical treatment given in the therapeutic community. Measurement will be conducted by assessors blind to group allocation at 4 time points: T1- pre-intervention; T2- post-intervention; T3- at a 1-month follow-up; and T4- at a 3-month follow-up.
Population: Forty-eight adults diagnosed with SUD, aged 18-45 years, with no significant cognitive deficits, and residing in a TC for SUD.
Tools: Both objective and subjective measures to evaluate TC performance will be applied. Additionally, interviews will be conducted to provide a deeper understanding of the perceived performance and difficulties.
Expected Results: F-CaST will lead to improved rehabilitation success and treatment duration, better compliance with TC requirements, and greater satisfaction, compared to control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with an experimental group and a control group
| Arm | Type | Receives |
|---|---|---|
| F-CaST | Experimental | Other: Functional Cognitive and Sensory Treatment (F-CaST)The experimental group who will receive the Functional Cognitive and Sensory Treatment (F-CaST)- in which therapy is individually tailored for successful task performance and where the focus is on strategies for improving sensory and EF deficits. |
| Standard Care | No intervention | –Standard care at the therapeutic community for SUD. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed by a psychiatrist and meeting the DSM-V diagnostic criteria for severe SUD
- Admitted to the therapeutic community (TC) for full-length SUD rehabilitation and with no more than 3 previous rehabilitation trials in this TC
- Abstained from drugs and alcohol for at least 14 days (verifying minimum withdrawal effects); and no more than 21 days of TC residency (to ensure familiarization with the facility)
- Without a significant cognitive deficit [the Montreal Cognitive Assessment (MoCA)≥19/30 points) and adequate language skills
Key exclusion criteria (1 listed)
- Relapsing substance use in the TC
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 |
|---|---|---|
| Functional Cognitive and Sensory Treatment (F-CaST)Also: Cognitive sensory occupational therapyF-CaST, a client-centered care, is a functional cognitive sensory intervention focusing on improving Executive Function (EF) and sensory modulation impairments using a modification of the Functional and Cognitive Occupational Therapy Treatment. | Other | F-CaST |
Primary outcome
Change The Canadian Occupational Performance Measure (COPM)
Time frame: Change in The Canadian Occupational Performance Measure between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), to T3 (follow-up- one month later) and T4 (follow-up- three months later). Higher scores indicate better outcomes
The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure for individuals to identify and prioritize everyday issues that restrict their participation in everyday living. Participants will define three goals, and rate their current performance \& satisfaction for each goal using a 10-point scale. Higher scores indicate better outcomes.
Length of stay in Therapeutic Community
Time frame: At T4 ( three months later after follow-up) or earlier (when they leave the TC)
Length of stay (days) residing in Therapeutic Community. Longer time spent in the TC is better.
Change in Performance in the Therapeutic Community
Time frame: Change in Performance in the Therapeutic Community between pre (T1-week 0) - to post (T2- post-intervention 8-9 weeks later) to T3 (follow-up- one month later) and T4 (follow-up- three months later).
Participant performance in the Therapeutic Community will be based on the community counselor's evaluation. Better performance is better
Change in number of times coming late for scheduled appointments
Time frame: Change in number of times coming late for scheduled appointments between pre (T1-week 0) - to post (T2- post-intervention 8-9 weeks later) to T3 (follow-up- one month later) and T4 (follow-up- three months later).
Number of times coming late for scheduled appointments. Less times of coming late is better.
11 secondary outcomes
Four Item Tablet Test (4ITT)
Time frame: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
Color Trails Test (CTT)
Time frame: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Time frame: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
Computerized cognitive assessment battery (CANTAB)
Time frame: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
The Self-Regulation Skills Interview
Time frame: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
The Sensory Responsiveness Questionnaire-Intensity Scale
Time frame: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
The Pain Sensitivity Questionnaire
Time frame: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
The New General Self-Efficacy Scale
Time frame: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
Satisfaction with Life Scale
Time frame: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)]
In-depth semi-structured interview
Time frame: Pre (T1-week 0), T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) - 12 item version
Time frame: Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)
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 11 Apr 2024.
- Derived from this study: PubMed 38594737Assayag N, Bar-Shalita T, Rand D. The Functional-Cognitive and Sensory Treatment (F-CaST) to improve rehabilitation outcomes of individuals with substance use disorder: a study protocol for a mixed-method randomized controlled trial. Addict Sci Clin Pract. 2024 Apr 9;19(1):28. doi: 10.1186/s13722-024-00449-7.
- Individual participant dataSharing planned: No. Data will be available upon personal request
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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.
Naama Assayag, Dr. principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Cognitive and Sensory Treatment (F-CaST) in people with Substance Use Disorders, run by Tel Aviv University at 1 site in Israel.
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 1 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 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Change The Canadian Occupational Performance Measure (COPM) (time frame: Change in The Canadian Occupational Performance Measure between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), to T3 (follow-up- one month later) and T4 (follow-up- three months later). Higher scores indicate better outcomes). 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 NCT05647863, which also lists 1 linked publication.
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 11 Apr 2024.