AnxietySmart-CATNCT02259036
Using Smartphones to Enhance the Treatment of Childhood Anxiety
A study testing Ecological Momentary Treatment Enhancement in people with Anxiety, run by University of Pittsburgh at 1 site in United States.
Trial summary
The primary goal of this research study is to develop an interactive smartphone app that could be used to increase the effectiveness of talk therapy such as cognitive behavioral therapy (CBT) for child anxiety. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Ecological Momentary Treatment Enhancement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 31 May 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants will be 40 children of either sex ages 9 years, 0 months to 14 years, 11 months with DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and/or Social Phobia (SP) as identified by the Kiddie Schedule of Affective Disorders.
- The primary caregiver is defined as the person who has the most responsibility for taking care of the child. While this is typically the mother, it can be the father, an adoptive parent or other legal guardian. The primary caregiver must be a legal guardian of the child.
Who cannot join
- Requires current ongoing treatment with psychoactive medications other than stimulants.
- Acutely suicidal or at risk for harm to self or others.
- Neuromuscular or neurological disorder.
- Reading level below 80 on the Wide Range Achievement Test-4 (WRAT-4)
- Medical illnesses or medications taken for an illness as determined by study physicians that would affect study adherence, and subject's emotional state.
- Current comorbid diagnosis of: primary major depressive disorder (MDD) (subjects who have primary GAD with co-morbid MDD that is secondary in terms of course and functional impact are not excluded), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), conduct disorder, substance abuse or dependence, and ADHD combined type or predominantly hyperactive-impulsive type.
- Lifetime diagnosis of autism spectrum disorder, bipolar disorder, psychotic depression, schizophrenia, or schizoaffective disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh, Dept. of Psychology
Pittsburgh, Pennsylvania, 15213
About this study
The primary goal of this research study is to develop an interactive smartphone app that could be used to increase the effectiveness of talk therapy such as cognitive behavioral therapy (CBT) for child anxiety.
Read the detailed description
Boys and girls between the ages of 9-14 who have anxiety and a parent or caregiver are being asked to participate in this study. Interested participants who contact the study will be asked to undergo a brief phone pre-screen to determine initial eligibility.
After completing a phone pre-screen, potential participants for the Phase 2 trial will be invited to the lab to complete a clinical intake interview. Clinical information will be obtained from parent and child by a trained research staff member. The research staff member will have specific training to a high degree of reliability in conducting the diagnostic interviews relevant to this research study.
Participants that meet study criteria based on the clinical information obtained at the first study visit will be invited to begin a course of Cognitive Behavior Therapy (CBT), an empirically validated talk therapy commonly used to treat children with anxiety. Children will receive individual treatment using the Brief Coping Cat Manual. The Coping Cat program (Kendall 1994) is an empirically supported child-focused CBT treatment for children with anxiety disorders. Throughout the program, children are encouraged to practice techniques learned during therapy sessions through homework or "Show-That-I-Can" (STIC) tasks. Parents attend weekly check-ins and two parent-only sessions. STIC tasks will consist of specific SmartCAT modules in the smartphone app as assigned at the end of each session. Participants might be asked to interact with other children and adolescents or study staff as well as leave the therapy building. This is to allow participants to become more comfortable in situations that make them feel anxious by gradually exposing them to the specific situation. Parents are not treated as co-clients, but are considered consultants to the child's treatment and are asked to provide some collaboration and assistance in exposure planning and homework.
Treatment will be delivered by Masters-level therapists who will have completed training in CBT. They will attend a weekly supervision session with Dr. Silk, with consultation from Dr. Kendall on difficult cases via videoconference. All sessions will be videotaped.
SMARTPHONE PROTOCOL:
Prior to the first therapy session, the child and a parent will be trained how to use the SmartCAT app. Youth will be provided with an Android smartphone for the duration of the study. If the child already has an Android phone, the app will be installed on the participant's phone in order to decrease participant burden of carrying an additional phone.
Participants will be given a study-provided, pre-programmed smartphone on which they will enter their responses to a series of questions about moods and daily experiences using an app developed for this study. The child will receive an electronic notification message once per day and will be prompted through a series of questions about what he/she is doing, who he/she is with, how he/she is feeling, worries or stressful events, and how he/she coped with these events. It should take the child approximately 5 minutes each time to complete the questions. The child will only be prompted to answer these questions outside of school hours and on weekends. Participant data will be securely sent to study therapists via a clinician portal connected to the app to be reviewed weekly. The therapists may then integrate this information into treatment and provide customized feedback to the patient.
Parents will be asked to complete an online diary to keep track of what skills their child uses during the week. After completion of the initial screening visit, parents are asked to complete the Skills Use Diary daily for seven days. After this seven day period, they will be asked to complete a diary entry twice per week throughout 8 weeks of treatment, totaling 30 entries. At the end of treatment, subjects will again be asked to complete the diary daily for another seven days. Participants will receive links to the online diary and instructions for completion via email (see references and other attachments for the email script). Diaries should take no longer than 10 min per day to complete. The data will be encrypted and stored securely through the online survey system Qualtrics.
POST-TREATMENT and 2-MONTH FOLLOW-UP:
All clinical, skill acquisition, and skill utilization measures (including the parent 7 day diary) will be repeated at post-treatment (approximately 10 weeks) and 2 month follow-up We will use Qualtrics, a secure internet data collection system, for administering diaries and questionnaires.
- Conditions
- Anxiety
- Being tested
- Ecological Momentary Treatment Enhancement
- Keywords
- child anxiety, worries, fears, talk therapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Momentary Treatment EnhancementOther
Participants will be given a pre-programmed smartphone on which they will enter their responses to a series of questions about moods and daily experiences using an app developed for this study. The child will receive an electronic notification message once per day and will be prompted through a series of questions about what he/she is doing, who he/she is with, how he/she is feeling, worries or stressful events, and how he/she coped with these events. It should take the child approximately 5 minutes each time to complete the questions. Participant data will be sent to study therapists to be reviewed weekly. The therapist will integrate this information into treatment and provide customized feedback to the patient.
| Study group | Role | What they receive |
|---|---|---|
| SmartCAT Enhanced Treatment | Other | Cognitive Behavioral Therapy enhanced with an ecological momentary treatment enhancement smartphone app called SmartCAT. Receives: Other: Ecological Momentary Treatment Enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
PARS Treatment response
Anxiety severity will be rated by an IE on the Pediatric Anxiety Rating Scale (PARS) (RUPP Study Group, 2002). A total score was computed by summing six items assessing anxiety severity, frequency, distress, avoidance, and interference during the previous week. Treatment response will be defined as a 35% reduction in PARS from pre- to post-treatment.
Measured: 10 weeks
Secondary outcomes (1)
Absence of diagnosis on K-SADS
Recovery will be defined as an absence of DSM 5 diagnosis of Separation Anxiety, Social Anxiety, and Generalized Anxiety Disorder on the K-SADS interview.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startAug 2014
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jennifer Silk, University of Pittsburgh
- Investigators
- Jennifer S Silk, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259036
- Sponsor's protocol ID
- MH102666
- Other IDs
- 1R34MH102666-01A1
- Acronym
- Smart-CAT
- Status last verified
- Nov 2018
- First submitted
- 24 Sep 2014
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Achenbach, T. M. (1991). Manual for the Child Behavior Checklist/4-18 and 1991 Profile. Burlington: University of Vermont, Department of Psychiatry.
Angold, A., Costello, E. J., Messer, S. C., Pickles, A., Winder, F., & Silver, D. (1995). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. Interenational Journal of Methods in Psychiatric Research, 5, 237-249.
Birmaher, B., Khetarpal, S., Cully, M., Brent, D. A., & McKenzie, S. (2003). Screen for Child Anxiety Related Disorders (SCARED)--Parent form and child form (8 years and older). In L. VandeCreek (Ed.), Ellis Human Development Institute. (pp. 99-104). Sarasota, FL: Professional Resource Press/Professional Resource Exchange, Inc.
Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6. doi: 10.1097/00004583-199910000-00011.
PubMed 10517055Compas BE, Connor-Smith JK, Saltzman H, Thomsen AH, Wadsworth ME. Coping with stress during childhood and adolescence: problems, progress, and potential in theory and research. Psychol Bull. 2001 Jan;127(1):87-127.
PubMed 11271757Connor-Smith JK, Compas BE, Wadsworth ME, Thomsen AH, Saltzman H. Responses to stress in adolescence: measurement of coping and involuntary stress responses. J Consult Clin Psychol. 2000 Dec;68(6):976-92.
PubMed 11142550Constantino, J. N. (2002). The Social Responsiveness Scale, Los Angeles: Western Psychological Services.
Guy W (1976): The clinical global impression scale. The ECDEU Assessment Manual for Psychopharmacology-Revised Rockville, MD U.S. Department of Health, Education, and Welfare Public Health Service, Alcohol, Drug Abuse, Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research.
Harter, S. (1988). Manual for the Self-perception Profile for Adolescents Denver, CO: University of Denver.
Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8. doi: 10.1097/00004583-199707000-00021.
PubMed 9204677Kendall PC. Treating anxiety disorders in children: results of a randomized clinical trial. J Consult Clin Psychol. 1994 Feb;62(1):100-10. doi: 10.1037//0022-006x.62.1.100.
PubMed 8034812Langley AK, Bergman RL, McCracken J, Piacentini JC. Impairment in childhood anxiety disorders: preliminary examination of the child anxiety impact scale-parent version. J Child Adolesc Psychopharmacol. 2004 Spring;14(1):105-14. doi: 10.1089/104454604773840544.
PubMed 15142397Reynolds S, Wilson C, Austin J, Hooper L. Effects of psychotherapy for anxiety in children and adolescents: a meta-analytic review. Clin Psychol Rev. 2012 Jun;32(4):251-62. doi: 10.1016/j.cpr.2012.01.005. Epub 2012 Feb 13.
PubMed 22459788Pine DS, Cohen P, Gurley D, Brook J, Ma Y. The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders. Arch Gen Psychiatry. 1998 Jan;55(1):56-64. doi: 10.1001/archpsyc.55.1.56.
PubMed 9435761Ronan, K. R., Kendall, P. C., & Rowe, M. (1994). Negative affectivity in children: Development and validation of a self-statement questionnaire. Cognitive Therapy and Research, 18(6), 509-528.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Smartphones to Enhance the Treatment of Childhood Anxiety
- ClinicalTrials.gov ID
- NCT02259036
- Acronym / sponsor ID
- Smart-CAT / MH102666
- Conditions
- Anxiety
- Keywords
- child anxiety, worries, fears, talk therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2014
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 8 Oct 2014 (estimated)
- 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 primary goal of this research study is to develop an interactive smartphone app that could be used to increase the effectiveness of talk therapy such as cognitive behavioral therapy (CBT) for child anxiety.
Detailed description
Boys and girls between the ages of 9-14 who have anxiety and a parent or caregiver are being asked to participate in this study. Interested participants who contact the study will be asked to undergo a brief phone pre-screen to determine initial eligibility.
After completing a phone pre-screen, potential participants for the Phase 2 trial will be invited to the lab to complete a clinical intake interview. Clinical information will be obtained from parent and child by a trained research staff member. The research staff member will have specific training to a high degree of reliability in conducting the diagnostic interviews relevant to this research study.
Participants that meet study criteria based on the clinical information obtained at the first study visit will be invited to begin a course of Cognitive Behavior Therapy (CBT), an empirically validated talk therapy commonly used to treat children with anxiety. Children will receive individual treatment using the Brief Coping Cat Manual. The Coping Cat program (Kendall 1994) is an empirically supported child-focused CBT treatment for children with anxiety disorders. Throughout the program, children are encouraged to practice techniques learned during therapy sessions through homework or "Show-That-I-Can" (STIC) tasks. Parents attend weekly check-ins and two parent-only sessions. STIC tasks will consist of specific SmartCAT modules in the smartphone app as assigned at the end of each session. Participants might be asked to interact with other children and adolescents or study staff as well as leave the therapy building. This is to allow participants to become more comfortable in situations that make them feel anxious by gradually exposing them to the specific situation. Parents are not treated as co-clients, but are considered consultants to the child's treatment and are asked to provide some collaboration and assistance in exposure planning and homework.
Treatment will be delivered by Masters-level therapists who will have completed training in CBT. They will attend a weekly supervision session with Dr. Silk, with consultation from Dr. Kendall on difficult cases via videoconference. All sessions will be videotaped.
SMARTPHONE PROTOCOL:
Prior to the first therapy session, the child and a parent will be trained how to use the SmartCAT app. Youth will be provided with an Android smartphone for the duration of the study. If the child already has an Android phone, the app will be installed on the participant's phone in order to decrease participant burden of carrying an additional phone.
Participants will be given a study-provided, pre-programmed smartphone on which they will enter their responses to a series of questions about moods and daily experiences using an app developed for this study. The child will receive an electronic notification message once per day and will be prompted through a series of questions about what he/she is doing, who he/she is with, how he/she is feeling, worries or stressful events, and how he/she coped with these events. It should take the child approximately 5 minutes each time to complete the questions. The child will only be prompted to answer these questions outside of school hours and on weekends. Participant data will be securely sent to study therapists via a clinician portal connected to the app to be reviewed weekly. The therapists may then integrate this information into treatment and provide customized feedback to the patient.
Parents will be asked to complete an online diary to keep track of what skills their child uses during the week. After completion of the initial screening visit, parents are asked to complete the Skills Use Diary daily for seven days. After this seven day period, they will be asked to complete a diary entry twice per week throughout 8 weeks of treatment, totaling 30 entries. At the end of treatment, subjects will again be asked to complete the diary daily for another seven days. Participants will receive links to the online diary and instructions for completion via email (see references and other attachments for the email script). Diaries should take no longer than 10 min per day to complete. The data will be encrypted and stored securely through the online survey system Qualtrics.
POST-TREATMENT and 2-MONTH FOLLOW-UP:
All clinical, skill acquisition, and skill utilization measures (including the parent 7 day diary) will be repeated at post-treatment (approximately 10 weeks) and 2 month follow-up We will use Qualtrics, a secure internet data collection system, for administering diaries and questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmartCAT Enhanced Treatment | Other | Other: Ecological Momentary Treatment EnhancementCognitive Behavioral Therapy enhanced with an ecological momentary treatment enhancement smartphone app called SmartCAT. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participants will be 40 children of either sex ages 9 years, 0 months to 14 years, 11 months with DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and/or Social Phobia (SP) as identified by the Kiddie Schedule of Affective Disorders.
- The primary caregiver is defined as the person who has the most responsibility for taking care of the child. While this is typically the mother, it can be the father, an adoptive parent or other legal guardian. The primary caregiver must be a legal guardian of the child.
Key exclusion criteria (7 listed)
- Requires current ongoing treatment with psychoactive medications other than stimulants.
- Acutely suicidal or at risk for harm to self or others.
- Neuromuscular or neurological disorder.
- Reading level below 80 on the Wide Range Achievement Test-4 (WRAT-4)
- Medical illnesses or medications taken for an illness as determined by study physicians that would affect study adherence, and subject's emotional state.
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 |
|---|---|---|
| Ecological Momentary Treatment EnhancementParticipants will be given a pre-programmed smartphone on which they will enter their responses to a series of questions about moods and daily experiences using an app developed for this study. The child will receive an electronic notification message once per day and will be prompted through a series of questions about what he/she is doing, who he/she is with, how he/she is feeling, worries or stressful events, and how he/she coped with these events. It should take the child approximately 5 minutes each time to complete the questions. Participant data will be sent to study therapists to be reviewed weekly. The therapist will integrate this information into treatment and provide customized feedback to the patient. | Other | SmartCAT Enhanced Treatment |
Primary outcome
PARS Treatment response
Time frame: 10 weeks
Anxiety severity will be rated by an IE on the Pediatric Anxiety Rating Scale (PARS) (RUPP Study Group, 2002). A total score was computed by summing six items assessing anxiety severity, frequency, distress, avoidance, and interference during the previous week. Treatment response will be defined as a 35% reduction in PARS from pre- to post-treatment.
1 secondary outcome
Absence of diagnosis on K-SADS
Time frame: 10 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 16 Nov 2018.
- BackgroundAchenbach, T. M. (1991). Manual for the Child Behavior Checklist/4-18 and 1991 Profile. Burlington: University of Vermont, Department of Psychiatry.
- BackgroundAngold, A., Costello, E. J., Messer, S. C., Pickles, A., Winder, F., & Silver, D. (1995). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. Interenational Journal of Methods in Psychiatric Research, 5, 237-249.
- BackgroundBirmaher, B., Khetarpal, S., Cully, M., Brent, D. A., & McKenzie, S. (2003). Screen for Child Anxiety Related Disorders (SCARED)--Parent form and child form (8 years and older). In L. VandeCreek (Ed.), Ellis Human Development Institute. (pp. 99-104). Sarasota, FL: Professional Resource Press/Professional Resource Exchange, Inc.
- Background: PubMed 10517055Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6. doi: 10.1097/00004583-199910000-00011.
- Background: PubMed 11271757Compas BE, Connor-Smith JK, Saltzman H, Thomsen AH, Wadsworth ME. Coping with stress during childhood and adolescence: problems, progress, and potential in theory and research. Psychol Bull. 2001 Jan;127(1):87-127.
- Background: PubMed 11142550Connor-Smith JK, Compas BE, Wadsworth ME, Thomsen AH, Saltzman H. Responses to stress in adolescence: measurement of coping and involuntary stress responses. J Consult Clin Psychol. 2000 Dec;68(6):976-92.
- BackgroundConstantino, J. N. (2002). The Social Responsiveness Scale, Los Angeles: Western Psychological Services.
- BackgroundGuy W (1976): The clinical global impression scale. The ECDEU Assessment Manual for Psychopharmacology-Revised Rockville, MD U.S. Department of Health, Education, and Welfare Public Health Service, Alcohol, Drug Abuse, Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research.
- BackgroundHarter, S. (1988). Manual for the Self-perception Profile for Adolescents Denver, CO: University of Denver.
- Background: PubMed 9204677Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8. doi: 10.1097/00004583-199707000-00021.
- Background: PubMed 8034812Kendall PC. Treating anxiety disorders in children: results of a randomized clinical trial. J Consult Clin Psychol. 1994 Feb;62(1):100-10. doi: 10.1037//0022-006x.62.1.100.
- Background: PubMed 15142397Langley AK, Bergman RL, McCracken J, Piacentini JC. Impairment in childhood anxiety disorders: preliminary examination of the child anxiety impact scale-parent version. J Child Adolesc Psychopharmacol. 2004 Spring;14(1):105-14. doi: 10.1089/104454604773840544.
- 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.
Jennifer S Silk, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological Momentary Treatment Enhancement in people with Anxiety, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 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 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PARS Treatment response (time frame: 10 weeks). 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 NCT02259036, which also lists 22 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 16 Nov 2018.