Chronic DiseaseNCT05468788
Theatre in Adolescents With Chronic Medical Conditions (CMCs)
A study testing Intervention: Integrative Community Therapy-based Psychodrama in people with Chronic Disease, run by Geisinger Clinic at 1 site in United States.
Trial summary
Investigators are building a program that uses improvisation to teach kids and teens with medical issues healthy ways to cope. Medical issues have been linked to anxiety and depression. Doing theatre can prevent these complications. Read more about this study
- Who is it for?
- Ages 5 to 19 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Intervention: Integrative Community Therapy-based Psychodrama
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to 31 Aug 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 5 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Identify as having a CMC
- In grades kindergarten to 12th grade during the year recruited for the study
- 5 years of age and ≤ 19 years of age at the start of the intervention
- Able and willing to participate in improvisational theatre in spoken English
- Able to understand and answer standard questionnaires used for evaluation in English (with or without accommodation)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Primary Care South Wilkes-Barre
Wilkes-Barre, Pennsylvania, 18702
About this study
Official title: Evaluating the Use of Theatre to Decrease Depression and Anxiety Among Adolescents With Chronic Medical Conditions (CMCs)
Investigators are building a program that uses improvisation to teach kids and teens with medical issues healthy ways to cope. Medical issues have been linked to anxiety and depression. Doing theatre can prevent these complications. Participants will meet in groups of about ten for ten weeks to do improvisation that is fun and supportive. Participants will meet with a study team member before the program starts, after the program ends, six months after the program ends, and twelve months after the program ends. At these visits, participants will be screened for anxiety, depression, quality of life, and will be given a short interview.
Read the detailed description
Adolescents with chronic medical conditions are at increased risk for anxiety and depression compared to other people their age. Therapies that use role-play prevent anxiety and depression. However, often these studies do not have an underlying psychological framework, or there is not enough information to replicate the program. Investigators designed an intervention using role-play based on Integrative Community Therapy, developed in the 1980s by Dr. Adalberto Barreto. This program will help adolescents with chronic medical conditions explore their feelings about issues related to having a chronic condition, learn new coping strategies, and help one another find support among peers.
This treatment will take place once a week for 10 weeks and investigators will compare the effects to those derived from improvisational theatre alone. To evaluate this new treatment, the study team will screen participants for anxiety, depression, quality of life, and will give a short qualitative interview. This will occur before and after the intervention, 6 months after the intervention, and 1 year after the intervention.
- Conditions
- Chronic Disease
- Being tested
- Intervention: Integrative Community Therapy-based Psychodrama, Control: Improvisational Theatre
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Integrative Community Therapy-based PsychodramaBehavioural
Also called Intervention: ICT-based Psychodrama
Participants produce theatre scenes depicting issues that they have experienced. Group leaders then use a guide to facilitate a discussion of participants' feelings, coping strategies, and sharing of local knowledge.
Control: Improvisational TheatreBehavioural
Participants play improvisational theatre games.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Community Therapy (ICT) Intervention Arm | Experimental | Participants will perform scenes related to having a chronic medical condition and they will be guided through conversations about their feelings and coping methods. Receives: Behavioral: Intervention: Integrative Community Therapy-based Psychodrama |
| Improvisational Theatre Arm | Sham comparator | Participants will perform generic improvisational theatre with no instruction on feelings or coping methods. Receives: Behavioral: Control: Improvisational Theatre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and Depression
Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome
Measured: Baseline to 10 weeks
Anxiety and Depression
Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome
Measured: Baseline to 6 months
Anxiety and Depression
Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome
Measured: Baseline to 12 months
Disease-Related Quality of Life
Disease-Related Quality of Life as evaluated by Qualitative Interview
Measured: Baseline to 10 weeks
Disease-Related Quality of Life
Disease-Related Quality of Life as evaluated by Qualitative Interview
Measured: Baseline to 6 months
Disease-Related Quality of Life
Disease-Related Quality of Life as evaluated by Qualitative Interview
Measured: Baseline to 12 months
Disease-Related Quality of Life
Disease-Related Quality of Life as evaluated by Pediatric Quality of Life Inventory; Scored 0-100; higher score indicates better outcome
Measured: Baseline to 10 weeks
Disease-Related Quality of Life
Disease-Related Quality of Life as evaluated by Pediatric Quality of Life Inventory; Scored 0-100; higher score indicates better outcome
Measured: Baseline to 6 months
Disease-Related Quality of Life
Disease-Related Quality of Life as evaluated by Pediatric Quality of Life Inventory; Scored 0-100; higher score indicates better outcome
Measured: Baseline to 12 months
Knowledge and Utilization of Coping Strategies
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Measured: Baseline to 10 weeks
Knowledge and Utilization of Coping Strategies
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Measured: Baseline to 6 months
Knowledge and Utilization of Coping Strategies
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Measured: Baseline to 12 months
Knowledge and Utilization of Coping Strategies
Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome
Measured: Baseline to 10 weeks
Knowledge and Utilization of Coping Strategies
Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome
Measured: Baseline to 6 months
Knowledge and Utilization of Coping Strategies
Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome
Measured: Baseline to 12 months
Empathy
Empathy as evaluated by Qualitative Interview
Measured: Baseline to 10 weeks
Empathy
Empathy as evaluated by Qualitative Interview
Measured: Baseline to 6 months
Empathy
Empathy as evaluated by Qualitative Interview
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start24 May 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Why it stopped: Not enough participants were recruited to conduct a randomized controlled trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One group will receive a new behavioral intervention; the other group will receive improvisational theatre alone
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen A Ephlin, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468788
- Sponsor's protocol ID
- 2022-0322
- Status last verified
- Aug 2024
- First submitted
- 12 Jul 2022
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Young KS, Sandman CF, Craske MG. Positive and Negative Emotion Regulation in Adolescence: Links to Anxiety and Depression. Brain Sci. 2019 Mar 29;9(4):76. doi: 10.3390/brainsci9040076.
PubMed 30934877Jones LC, Mrug S, Elliott MN, Toomey SL, Tortolero S, Schuster MA. Chronic Physical Health Conditions and Emotional Problems From Early Adolescence Through Midadolescence. Acad Pediatr. 2017 Aug;17(6):649-655. doi: 10.1016/j.acap.2017.02.002. Epub 2017 Feb 12.
PubMed 28215656Cobham VE, Hickling A, Kimball H, Thomas HJ, Scott JG, Middeldorp CM. Systematic Review: Anxiety in Children and Adolescents With Chronic Medical Conditions. J Am Acad Child Adolesc Psychiatry. 2020 May;59(5):595-618. doi: 10.1016/j.jaac.2019.10.010. Epub 2019 Oct 30.
PubMed 31676391Compas BE, Jaser SS, Dunn MJ, Rodriguez EM. Coping with chronic illness in childhood and adolescence. Annu Rev Clin Psychol. 2012;8:455-80. doi: 10.1146/annurev-clinpsy-032511-143108. Epub 2011 Dec 20.
PubMed 22224836Greenberg MT, Weissberg RP, O'Brien MU, Zins JE, Fredericks L, Resnik H, Elias MJ. Enhancing school-based prevention and youth development through coordinated social, emotional, and academic learning. Am Psychol. 2003 Jun-Jul;58(6-7):466-74. doi: 10.1037/0003-066x.58.6-7.466.
PubMed 12971193Hersov L. Psychotherapy for Children and Adolescents. Evidence-based Treatments and Case Examples. Child Adolesc Ment Health. 2006 May;11(2):124-125. doi: 10.1111/j.1475-3588.2006.00399_5.x. No abstract available.
PubMed 32811094Feniger-Schaal R, Koren-Karie N. Using Drama Therapy to Enhance Maternal Insightfulness and Reduce Children's Behavior Problems. Front Psychol. 2021 Jan 20;11:586630. doi: 10.3389/fpsyg.2020.586630. eCollection 2020.
PubMed 33551907Blacker J, Watson A, Beech AR. A combined drama-based and CBT approach to working with self-reported anger aggression. Crim Behav Ment Health. 2008;18(2):129-37. doi: 10.1002/cbm.686.
PubMed 18383198Joronen K, Hakamies A, Astedt-Kurki P. Children's experiences of a drama programme in social and emotional learning. Scand J Caring Sci. 2011 Dec;25(4):671-8. doi: 10.1111/j.1471-6712.2011.00877.x. Epub 2011 Mar 1.
PubMed 21362006Daykin N, Orme J, Evans D, Salmon D, McEachran M, Brain S. The impact of participation in performing arts on adolescent health and behaviour: a systematic review of the literature. J Health Psychol. 2008 Mar;13(2):251-64. doi: 10.1177/1359105307086699.
PubMed 18375630Joronen K, Rankin SH, Astedt-Kurki P. School-based drama interventions in health promotion for children and adolescents: systematic review. J Adv Nurs. 2008 Jul;63(2):116-31. doi: 10.1111/j.1365-2648.2008.04634.x.
PubMed 18537845Miranda NA, Berardinelli LM, Saboia VM, Brito ID, Santos RD. Interdisciplinary care praxis in groups of people living with fibromyalgia. Rev Bras Enferm. 2016 Nov-Dec;69(6):1115-1123. doi: 10.1590/0034-7167-2016-0279. English, Portuguese.
PubMed 27925088Weigensberg MJ, Vigen C, Sequeira P, Spruijt-Metz D, Juarez M, Florindez D, Provisor J, Peters A, Pyatak EA. Diabetes Empowerment Council: Integrative Pilot Intervention for Transitioning Young Adults With Type 1 Diabetes. Glob Adv Health Med. 2018 Mar 8;7:2164956118761808. doi: 10.1177/2164956118761808. eCollection 2018.
PubMed 29552422Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8.
PubMed 10937431Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Theatre to Decrease Depression and Anxiety Among Adolescents With Chronic Medical Conditions (CMCs)
- ClinicalTrials.gov ID
- NCT05468788
- Acronym / sponsor ID
- 2022-0322
- Conditions
- Chronic Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough participants were recruited to conduct a randomized controlled trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 21 Jul 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.
Investigators are building a program that uses improvisation to teach kids and teens with medical issues healthy ways to cope. Medical issues have been linked to anxiety and depression. Doing theatre can prevent these complications. Participants will meet in groups of about ten for ten weeks to do improvisation that is fun and supportive. Participants will meet with a study team member before the program starts, after the program ends, six months after the program ends, and twelve months after the program ends. At these visits, participants will be screened for anxiety, depression, quality of life, and will be given a short interview.
Detailed description
Adolescents with chronic medical conditions are at increased risk for anxiety and depression compared to other people their age. Therapies that use role-play prevent anxiety and depression. However, often these studies do not have an underlying psychological framework, or there is not enough information to replicate the program. Investigators designed an intervention using role-play based on Integrative Community Therapy, developed in the 1980s by Dr. Adalberto Barreto. This program will help adolescents with chronic medical conditions explore their feelings about issues related to having a chronic condition, learn new coping strategies, and help one another find support among peers.
This treatment will take place once a week for 10 weeks and investigators will compare the effects to those derived from improvisational theatre alone. To evaluate this new treatment, the study team will screen participants for anxiety, depression, quality of life, and will give a short qualitative interview. This will occur before and after the intervention, 6 months after the intervention, and 1 year after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- One group will receive a new behavioral intervention; the other group will receive improvisational theatre alone
| Arm | Type | Receives |
|---|---|---|
| Integrative Community Therapy (ICT) Intervention Arm | Experimental | Behavioral: Intervention: Integrative Community Therapy-based PsychodramaParticipants will perform scenes related to having a chronic medical condition and they will be guided through conversations about their feelings and coping methods. |
| Improvisational Theatre Arm | Sham comparator | Behavioral: Control: Improvisational TheatreParticipants will perform generic improvisational theatre with no instruction on feelings or coping methods. |
Who may qualify
- Ages
- 5 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Identify as having a CMC
- In grades kindergarten to 12th grade during the year recruited for the study
- Able and willing to participate in improvisational theatre in spoken English
- Able to understand and answer standard questionnaires used for evaluation in English (with or without accommodation)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Intervention: Integrative Community Therapy-based PsychodramaAlso: Intervention: ICT-based PsychodramaParticipants produce theatre scenes depicting issues that they have experienced. Group leaders then use a guide to facilitate a discussion of participants' feelings, coping strategies, and sharing of local knowledge. | Behavioural | Integrative Community Therapy (ICT) Intervention Arm |
| Control: Improvisational TheatreParticipants play improvisational theatre games. | Behavioural | Improvisational Theatre Arm |
Primary outcome
Anxiety and Depression
Time frame: Baseline to 10 weeks
Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome
Anxiety and Depression
Time frame: Baseline to 6 months
Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome
Anxiety and Depression
Time frame: Baseline to 12 months
Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome
Disease-Related Quality of Life
Time frame: Baseline to 10 weeks
Disease-Related Quality of Life as evaluated by Qualitative Interview
Disease-Related Quality of Life
Time frame: Baseline to 6 months
Disease-Related Quality of Life as evaluated by Qualitative Interview
Disease-Related Quality of Life
Time frame: Baseline to 12 months
Disease-Related Quality of Life as evaluated by Qualitative Interview
Disease-Related Quality of Life
Time frame: Baseline to 10 weeks
Disease-Related Quality of Life as evaluated by Pediatric Quality of Life Inventory; Scored 0-100; higher score indicates better outcome
Disease-Related Quality of Life
Time frame: Baseline to 6 months
Disease-Related Quality of Life as evaluated by Pediatric Quality of Life Inventory; Scored 0-100; higher score indicates better outcome
Disease-Related Quality of Life
Time frame: Baseline to 12 months
Disease-Related Quality of Life as evaluated by Pediatric Quality of Life Inventory; Scored 0-100; higher score indicates better outcome
Knowledge and Utilization of Coping Strategies
Time frame: Baseline to 10 weeks
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Knowledge and Utilization of Coping Strategies
Time frame: Baseline to 6 months
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Knowledge and Utilization of Coping Strategies
Time frame: Baseline to 12 months
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Knowledge and Utilization of Coping Strategies
Time frame: Baseline to 10 weeks
Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome
Knowledge and Utilization of Coping Strategies
Time frame: Baseline to 6 months
Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome
Knowledge and Utilization of Coping Strategies
Time frame: Baseline to 12 months
Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome
Empathy
Time frame: Baseline to 10 weeks
Empathy as evaluated by Qualitative Interview
Empathy
Time frame: Baseline to 6 months
Empathy as evaluated by Qualitative Interview
Empathy
Time frame: Baseline to 12 months
Empathy as evaluated by Qualitative Interview
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Background: PubMed 30934877Young KS, Sandman CF, Craske MG. Positive and Negative Emotion Regulation in Adolescence: Links to Anxiety and Depression. Brain Sci. 2019 Mar 29;9(4):76. doi: 10.3390/brainsci9040076.
- Background: PubMed 28215656Jones LC, Mrug S, Elliott MN, Toomey SL, Tortolero S, Schuster MA. Chronic Physical Health Conditions and Emotional Problems From Early Adolescence Through Midadolescence. Acad Pediatr. 2017 Aug;17(6):649-655. doi: 10.1016/j.acap.2017.02.002. Epub 2017 Feb 12.
- Background: PubMed 31676391Cobham VE, Hickling A, Kimball H, Thomas HJ, Scott JG, Middeldorp CM. Systematic Review: Anxiety in Children and Adolescents With Chronic Medical Conditions. J Am Acad Child Adolesc Psychiatry. 2020 May;59(5):595-618. doi: 10.1016/j.jaac.2019.10.010. Epub 2019 Oct 30.
- Background: PubMed 22224836Compas BE, Jaser SS, Dunn MJ, Rodriguez EM. Coping with chronic illness in childhood and adolescence. Annu Rev Clin Psychol. 2012;8:455-80. doi: 10.1146/annurev-clinpsy-032511-143108. Epub 2011 Dec 20.
- Background: PubMed 12971193Greenberg MT, Weissberg RP, O'Brien MU, Zins JE, Fredericks L, Resnik H, Elias MJ. Enhancing school-based prevention and youth development through coordinated social, emotional, and academic learning. Am Psychol. 2003 Jun-Jul;58(6-7):466-74. doi: 10.1037/0003-066x.58.6-7.466.
- Background: PubMed 32811094Hersov L. Psychotherapy for Children and Adolescents. Evidence-based Treatments and Case Examples. Child Adolesc Ment Health. 2006 May;11(2):124-125. doi: 10.1111/j.1475-3588.2006.00399_5.x. No abstract available.
- Background: PubMed 33551907Feniger-Schaal R, Koren-Karie N. Using Drama Therapy to Enhance Maternal Insightfulness and Reduce Children's Behavior Problems. Front Psychol. 2021 Jan 20;11:586630. doi: 10.3389/fpsyg.2020.586630. eCollection 2020.
- Background: PubMed 18383198Blacker J, Watson A, Beech AR. A combined drama-based and CBT approach to working with self-reported anger aggression. Crim Behav Ment Health. 2008;18(2):129-37. doi: 10.1002/cbm.686.
- Background: PubMed 21362006Joronen K, Hakamies A, Astedt-Kurki P. Children's experiences of a drama programme in social and emotional learning. Scand J Caring Sci. 2011 Dec;25(4):671-8. doi: 10.1111/j.1471-6712.2011.00877.x. Epub 2011 Mar 1.
- Background: PubMed 18375630Daykin N, Orme J, Evans D, Salmon D, McEachran M, Brain S. The impact of participation in performing arts on adolescent health and behaviour: a systematic review of the literature. J Health Psychol. 2008 Mar;13(2):251-64. doi: 10.1177/1359105307086699.
- Background: PubMed 18537845Joronen K, Rankin SH, Astedt-Kurki P. School-based drama interventions in health promotion for children and adolescents: systematic review. J Adv Nurs. 2008 Jul;63(2):116-31. doi: 10.1111/j.1365-2648.2008.04634.x.
- Background: PubMed 27925088Miranda NA, Berardinelli LM, Saboia VM, Brito ID, Santos RD. Interdisciplinary care praxis in groups of people living with fibromyalgia. Rev Bras Enferm. 2016 Nov-Dec;69(6):1115-1123. doi: 10.1590/0034-7167-2016-0279. English, Portuguese.
- 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.
Karen A Ephlin, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Integrative Community Therapy-based Psychodrama in people with Chronic Disease, run by Geisinger Clinic 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 5 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: withdrawn, as of the sponsor's last update on 12 Aug 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 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Anxiety and Depression (time frame: Baseline to 10 weeks). The study lists 18 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 NCT05468788, which also lists 16 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 12 Aug 2024.