Social Media Addiction4-STEP-TPSNCT06498999
4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) Among Young Adults
A study testing 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) in people with Social Media Addiction, run by Government College University Faisalabad at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to develop a comprehensive Training Program intervention for social media addiction called the 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) and to learn if the 4-STEP-TPS will address and help manage the problems related to social media addiction. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Media Addiction
- What is being tested?
- 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2024to Nov 2024
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range: 18-30 years
- No physical, psychiatric, or psychological conditions
- Minimum score of 84 on the Social Networking Addiction Scale (SNAS)
- Minimum score of 60 on the Secure Flourish Index (SFI)
Who cannot join
- Age below 18 or above 30 years
- Presence of any physical, psychiatric, or psychological conditions
- Score below 84 on the Social Networking Addiction Scale (SNAS)
- Score below 60 on the Secure Flourish Index (SFI)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Government College University Faisalabad
Faisalābad, Punjab Province, 38000
Qasir Abbas, PhD, 923337683133, qasirabbas47@yahoo.com
About this study
Official title: Development and Validation of a 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) Among Young Adults: A Randomized Control Trial
The goal of this clinical trial is to develop a comprehensive Training Program intervention for social media addiction called the 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) and to learn if the 4-STEP-TPS will address and help manage the problems related to social media addiction. Other key objectives include the management of dysfunctional patterns, the promotion of positive patterns and healthy lifestyle, and the promotion of daily life activities and productivity.
Young Adult participants will take the 4-week 4-STEP-TPS Program with 1 weekly session in either individual or group settings or be placed on a waitlist control.
Read the detailed description
Participants In this research, a sample of N=400 young adults will be initially enrolled for eligibility screening assessment from all over Pakistan using purposive sampling techniques. The participants' age range will be 18-30 years having no physical/psychiatric/psychological conditions. N=90 participants after the eligibility assessment and screening will be allocated to experimental and waitlist treatment condition.
Expected Outcomes This study will provide valuable information to the mental health practitioners to treat and develop the guidelines and protocol for young adults with social media addiction. This 4-STEP-Training Program will provide understanding and insight to the participants about the problems related to social media addiction. Further, this training program will address the dysfunctional patterns associated with social media addiction, including FoMO and phubbing, as well as fatigue, insomnia, and psychological distress. Moreover, this training program will improve participants' productivity and flourishing while significantly reducing the level of social media addiction.
- Conditions
- Social Media Addiction
- Being tested
- 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS)
- Keywords
- Training Program, 4-STEP-Training Program for Social Media Addiction, Social Media Addiction, Social Networking, Flourishing, Dysfunctional Patterns, Fatigue Assessment Scale (FAS), Intervention
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-STEP-Training Program for Social Media Addiction (4-STEP-TPS)Behavioural
4 Modules with 1 Module being delivered in 1 weekly session of approximately 90 minutes. The details of each module/step is described as follows:
Step 1 (Module 1): S = Screening, Assessment and Psychoeducation: Involves screening and assessment of the problem, interpretation of the results, feedback and psychoeducation, identifying and breaking the resistance, motivation, and conceptualization.
Step 2 (Module 2): T = Treatment Conceptualization and Planning: Involves pattern identification, distortion identification, as well as pattern and distortions modifications.
Step 3 (Module 3): E = Effective Management Strategies: Involves management strategies to treat the earlier identified patterns as well as the implementation and confirmation of activities via a Pattern Schedule Chart.
Step 4 (Module 4): P = Prevention (Lapse-Relapse): Involves self-reflection and support building, monitoring and dependency check and slip plans and support additions
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Individual Setting | Experimental | 4-STEP-Training Program in 1-1 Setting Receives: Behavioral: 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) |
| Experimental Group: Group Setting | Experimental | 4-STEP-Training Program in Group Setting Receives: Behavioral: 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) |
| Control Group | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Networking Addiction Scale (SNAS)
The Social Networking Addiction Scale (SNAS) was developed to measure addiction of all forms of social networking across six-dimensions salience (items 1-4), mood modification (items 5-7), tolerance (items 8-10), withdrawal (items 11-14), conflict (item 15-17), and relapse (items 18-21) (Shahnawaz \& Rehman, 2020). The SNAS is a self-reported scale which entails 21-items scale rated on 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The score can range from 21 to 147. Any score above a total score of 84 signifies addiction. The scale has demonstrated good test-retest reliability of 0.88 and good validity as reported by Shahnawaz and Rehman (2020).
Measured: At screening, after 4 weeks, and reassessment up to 6 months
Secure Flourish Index (SFI)
The Secure Flourish Index (SFI) was developed to measure long-term flourishing across 6 domains happiness and life satisfaction (items 1-2), physical and mental health (items 3-4), meaning and purpose (items 5-6), character and virtue (items 7-8), close social relationships (items 9-10), and financial and material stability (items 11-12) (Weziak-Bialowolska et al., 2017). It is a self-report scale with 2 items for each of the 6 domains, totaling to 12 items rated on a scale of 0-10. Total scores range from 0 to 120 with higher scores indicating greater flourishing. It has an internal consistency of 0.85 and good construct validity (Weziak-Bialowolska et al., 2017).
Measured: At screening, after 4 weeks, and reassessment up to 6 months
Fear of Missing Out Scale (FoMOs)
The Fear of Missing out Scale (FoMOs) was developed to measure FoMO (Przybylski et al., 2013). It is a self-report questionnaire of 10-items rated on a 5-point Likert scale ranging from 1 (not at all true of me) to 5 (extremely true of me). The total scores of the scale range between 10 and 50, where higher scores indicate a higher level of fear of missing out. The scale has been shown to exhibit strong internal consistency of 0.87 to 0.90 and good validity (Przybylski et al., 2013).
Measured: At screening, after 4 weeks, and reassessment up to 6 months
Pubbing Scale (PS)
The Phubbing Scale was developed to measure the phubbing behaviors (Karadağ et al., 2015). The scale contains 10 items, rated from 1 (never) to 5 (always) in a 5-point Likert scale, the following 2 factors were found: (i) Factor 1 (1-5 items; α = .87) and (ii) Factor 2 (6-10 items; α = .85). The content of these factors can be summarized as follows:
(i) Communication disturbance: Higher scores indicate that participants often disturb their existing communications by dealing with their mobile phones in a face-to-face communication environment.
(ii) Phone obsession: Higher scores indicate that participants constantly need their mobile phone in environments lacking face-to-face communication.
Measured: At screening, after 4 weeks, and reassessment up to 6 months
Fatigue Assessment Scale (FAS)
The Fatigue Assessment Scale (FAS) was developed to evaluate the physical and mental symptoms of fatigue (Michielsen et al., 2003). It is a self-report measure with 10 items rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The scale has 2 subscales, with mental fatigue measured by the sum of items 3, 6, 7, 8, and 9 and physical fatigue measured by the sum of items 1, 2, 4, 5 and 10. Items 4 and 10 are reverse-scored. The total scores range from 10, indicating the lowest level of fatigue, to 50, indicating the highest level of fatigue. The scale has an internal consistency of 0.90 and good validity (Michielsen et al., 2003).
Measured: At screening, after 4 weeks, and reassessment up to 6 months
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) was developed as a screening measure for insomnia as well as an outcome measure in treatment research (Bastien et al., 2001). It is a self-report measure with 7 items rated on a 5-point Likert scale ranging from 0 to 4. The total scores range from 0 to 28, with higher scores indicating more acute insomnia symptoms. Although not validated, the developers suggest cutoff scores to be used for interpretation, with total scores of 0-7 indicating "no clinically significant insomnia," scores between 8-14 indicating "subthreshold insomnia," scores between 15-21 indicating "clinical insomnia (moderate severity)," and scores in the range 22-28 indicating "clinical insomnia (severe)." The scale has an internal consistency of 0.74 (Bastien et al., 2001).
Measured: At screening, after 4 weeks, and reassessment up to 6 months
Depression, Anxiety and Stress Scales (DASS)
The DASS-21 is the shortened version of the DASS-42 was designed to measure the symptoms of depression, anxiety, and stress (Lovibond \& Lovibond, 1995). It is a self-report measure with 21 items rated on a 4-point Likert scale ranging from 0 to 3. Each of the three DASS-21 scales depression (items 3, 5, 10, 13, 16, 17, 21), anxiety (items 2, 4, 7, 9, 15, 19, 20), and stress (items 1, 6, 8, 11, 12, 14, 18) contains 7 items. The scale has good internal consistency and construct validity in both clinical and non-clinical samples (Antony et al., 1998). Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score. After obtaining the final score for each depression, anxiety, and stress, the final score is compared to the recommended cut-off scores for severity levels (normal, moderate, severe).
Measured: At screening, after 4 weeks, and reassessment up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start15 May 2024
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Media AddictionStudies 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
- A randomized control trial design will be used in this study. It will be a three-arm study with the following groups: (1) an experimental group receiving the intervention in a group setting, (2) an experimental group receiving the intervention in an individual setting, and (3) a waitlist control group. In this research, a parallel group design will be used, with treatment given to all participants in a parallel manner. The allocation ratio and framework will be equivalence, meaning that each of the three groups will have an equal number of participants.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Government College University Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qasir Abbas, Government College University Faisalabad
- Investigators
- Qasir Abbas, PhD, Principal investigator, Assistant Professor - Clinical Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498999
- Sponsor's protocol ID
- GCUF
- Acronym
- 4-STEP-TPS
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 12 Jul 2024
- 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 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) Among Young Adults: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06498999
- Acronym / sponsor ID
- 4-STEP-TPS / GCUF
- Conditions
- Social Media Addiction
- Keywords
- Training Program, 4-STEP-Training Program for Social Media Addiction, Social Media Addiction, Social Networking, Flourishing, Dysfunctional Patterns, Fatigue Assessment Scale (FAS), Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Government College University FaisalabadUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 12 Jul 2024 (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 goal of this clinical trial is to develop a comprehensive Training Program intervention for social media addiction called the 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) and to learn if the 4-STEP-TPS will address and help manage the problems related to social media addiction. Other key objectives include the management of dysfunctional patterns, the promotion of positive patterns and healthy lifestyle, and the promotion of daily life activities and productivity.
Young Adult participants will take the 4-week 4-STEP-TPS Program with 1 weekly session in either individual or group settings or be placed on a waitlist control.
Detailed description
Participants In this research, a sample of N=400 young adults will be initially enrolled for eligibility screening assessment from all over Pakistan using purposive sampling techniques. The participants' age range will be 18-30 years having no physical/psychiatric/psychological conditions. N=90 participants after the eligibility assessment and screening will be allocated to experimental and waitlist treatment condition.
Expected Outcomes This study will provide valuable information to the mental health practitioners to treat and develop the guidelines and protocol for young adults with social media addiction. This 4-STEP-Training Program will provide understanding and insight to the participants about the problems related to social media addiction. Further, this training program will address the dysfunctional patterns associated with social media addiction, including FoMO and phubbing, as well as fatigue, insomnia, and psychological distress. Moreover, this training program will improve participants' productivity and flourishing while significantly reducing the level of social media addiction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized control trial design will be used in this study. It will be a three-arm study with the following groups: (1) an experimental group receiving the intervention in a group setting, (2) an experimental group receiving the intervention in an individual setting, and (3) a waitlist control group. In this research, a parallel group design will be used, with treatment given to all participants in a parallel manner. The allocation ratio and framework will be equivalence, meaning that each of the three groups will have an equal number of participants.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Individual Setting | Experimental | Behavioral: 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS)4-STEP-Training Program in 1-1 Setting |
| Experimental Group: Group Setting | Experimental | Behavioral: 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS)4-STEP-Training Program in Group Setting |
| Control Group | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range: 18-30 years
- No physical, psychiatric, or psychological conditions
- Minimum score of 84 on the Social Networking Addiction Scale (SNAS)
- Minimum score of 60 on the Secure Flourish Index (SFI)
Key exclusion criteria (4 listed)
- Age below 18 or above 30 years
- Presence of any physical, psychiatric, or psychological conditions
- Score below 84 on the Social Networking Addiction Scale (SNAS)
- Score below 60 on the Secure Flourish Index (SFI)
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 |
|---|---|---|
| 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS)4 Modules with 1 Module being delivered in 1 weekly session of approximately 90 minutes. The details of each module/step is described as follows: Step 1 (Module 1): S = Screening, Assessment and Psychoeducation: Involves screening and assessment of the problem, interpretation of the results, feedback and psychoeducation, identifying and breaking the resistance, motivation, and conceptualization. Step 2 (Module 2): T = Treatment Conceptualization and Planning: Involves pattern identification, distortion identification, as well as pattern and distortions modifications. Step 3 (Module 3): E = Effective Management Strategies: Involves management strategies to treat the earlier identified patterns as well as the implementation and confirmation of activities via a Pattern Schedule Chart. Step 4 (Module 4): P = Prevention (Lapse-Relapse): Involves self-reflection and support building, monitoring and dependency check and slip plans and support additions | Behavioural | Experimental Group: Group Setting, Experimental Group: Individual Setting |
Primary outcome
Social Networking Addiction Scale (SNAS)
Time frame: At screening, after 4 weeks, and reassessment up to 6 months
The Social Networking Addiction Scale (SNAS) was developed to measure addiction of all forms of social networking across six-dimensions salience (items 1-4), mood modification (items 5-7), tolerance (items 8-10), withdrawal (items 11-14), conflict (item 15-17), and relapse (items 18-21) (Shahnawaz \& Rehman, 2020). The SNAS is a self-reported scale which entails 21-items scale rated on 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The score can range from 21 to 147. Any score above a total score of 84 signifies addiction. The scale has demonstrated good test-retest reliability of 0.88 and good validity as reported by Shahnawaz and Rehman (2020).
Secure Flourish Index (SFI)
Time frame: At screening, after 4 weeks, and reassessment up to 6 months
The Secure Flourish Index (SFI) was developed to measure long-term flourishing across 6 domains happiness and life satisfaction (items 1-2), physical and mental health (items 3-4), meaning and purpose (items 5-6), character and virtue (items 7-8), close social relationships (items 9-10), and financial and material stability (items 11-12) (Weziak-Bialowolska et al., 2017). It is a self-report scale with 2 items for each of the 6 domains, totaling to 12 items rated on a scale of 0-10. Total scores range from 0 to 120 with higher scores indicating greater flourishing. It has an internal consistency of 0.85 and good construct validity (Weziak-Bialowolska et al., 2017).
Fear of Missing Out Scale (FoMOs)
Time frame: At screening, after 4 weeks, and reassessment up to 6 months
The Fear of Missing out Scale (FoMOs) was developed to measure FoMO (Przybylski et al., 2013). It is a self-report questionnaire of 10-items rated on a 5-point Likert scale ranging from 1 (not at all true of me) to 5 (extremely true of me). The total scores of the scale range between 10 and 50, where higher scores indicate a higher level of fear of missing out. The scale has been shown to exhibit strong internal consistency of 0.87 to 0.90 and good validity (Przybylski et al., 2013).
Pubbing Scale (PS)
Time frame: At screening, after 4 weeks, and reassessment up to 6 months
The Phubbing Scale was developed to measure the phubbing behaviors (Karadağ et al., 2015). The scale contains 10 items, rated from 1 (never) to 5 (always) in a 5-point Likert scale, the following 2 factors were found: (i) Factor 1 (1-5 items; α = .87) and (ii) Factor 2 (6-10 items; α = .85). The content of these factors can be summarized as follows: (i) Communication disturbance: Higher scores indicate that participants often disturb their existing communications by dealing with their mobile phones in a face-to-face communication environment. (ii) Phone obsession: Higher scores indicate that participants constantly need their mobile phone in environments lacking face-to-face communication.
Fatigue Assessment Scale (FAS)
Time frame: At screening, after 4 weeks, and reassessment up to 6 months
The Fatigue Assessment Scale (FAS) was developed to evaluate the physical and mental symptoms of fatigue (Michielsen et al., 2003). It is a self-report measure with 10 items rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The scale has 2 subscales, with mental fatigue measured by the sum of items 3, 6, 7, 8, and 9 and physical fatigue measured by the sum of items 1, 2, 4, 5 and 10. Items 4 and 10 are reverse-scored. The total scores range from 10, indicating the lowest level of fatigue, to 50, indicating the highest level of fatigue. The scale has an internal consistency of 0.90 and good validity (Michielsen et al., 2003).
Insomnia Severity Index (ISI)
Time frame: At screening, after 4 weeks, and reassessment up to 6 months
The Insomnia Severity Index (ISI) was developed as a screening measure for insomnia as well as an outcome measure in treatment research (Bastien et al., 2001). It is a self-report measure with 7 items rated on a 5-point Likert scale ranging from 0 to 4. The total scores range from 0 to 28, with higher scores indicating more acute insomnia symptoms. Although not validated, the developers suggest cutoff scores to be used for interpretation, with total scores of 0-7 indicating "no clinically significant insomnia," scores between 8-14 indicating "subthreshold insomnia," scores between 15-21 indicating "clinical insomnia (moderate severity)," and scores in the range 22-28 indicating "clinical insomnia (severe)." The scale has an internal consistency of 0.74 (Bastien et al., 2001).
Depression, Anxiety and Stress Scales (DASS)
Time frame: At screening, after 4 weeks, and reassessment up to 6 months
The DASS-21 is the shortened version of the DASS-42 was designed to measure the symptoms of depression, anxiety, and stress (Lovibond \& Lovibond, 1995). It is a self-report measure with 21 items rated on a 4-point Likert scale ranging from 0 to 3. Each of the three DASS-21 scales depression (items 3, 5, 10, 13, 16, 17, 21), anxiety (items 2, 4, 7, 9, 15, 19, 20), and stress (items 1, 6, 8, 11, 12, 14, 18) contains 7 items. The scale has good internal consistency and construct validity in both clinical and non-clinical samples (Antony et al., 1998). Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score. After obtaining the final score for each depression, anxiety, and stress, the final score is compared to the recommended cut-off scores for severity levels (normal, moderate, severe).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- 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.
Qasir Abbas, PhD principal investigator
Assistant Professor - Clinical Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) in people with Social Media Addiction, run by Government College University Faisalabad at 1 site in Pakistan.
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 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: status not confirmed, as of the sponsor's last update on 12 Jul 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 Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qasir Abbas, PhD (923337683133, qasirabbas47@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Networking Addiction Scale (SNAS) (time frame: At screening, after 4 weeks, and reassessment up to 6 months). The study lists 7 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 12 Jul 2024.