MTBI - Mild Traumatic Brain InjuryNCT05524402
Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
A study testing TOR-C 1 and TOR-C 2 in people with MTBI - Mild Traumatic Brain Injury and Anxiety, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- MTBI - Mild Traumatic Brain Injury, Anxiety
- What is being tested?
- TOR-C 1 and TOR-C 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2022to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female outpatients, ages 18-35
- English fluency and literacy
- Diagnosed with a concussion in the past 10 weeks
- Owns a smartphone or computer with Internet access
- Willingness and ability to participate in four 45-minute program sessions and answer remote questionnaires before, after, and 3-month following the program
- Free of concurrent psychotropic or have been on stable dosage for at least 6 weeks
- Clinically significant anxiety symptoms (score ≥ 5 on GAD-7 anxiety scale)
Who cannot join
- Previous history of moderate or severe TBI OR concussion in the past 2 years that resulted in symptoms lasting 3 months or more
- Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)
- Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder
- Current substance abuse or dependence and current substance use disorder
- Current active self-reported suicidal ideation
- Practice of mindfulness techniques for greater than 45 minutes per week within the last 3 months
- Participation in a mind-body or CBT treatment in the past 3 months
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02129
About this study
The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom).
Read the detailed description
The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom).
Each program will consist of four 45-minute sessions over the secure Zoom platform. Participants will receive a treatment manual. There are 3 assessment points consisting of self-report surveys: baseline, post program, and 3-month follow-up.
- Conditions
- MTBI - Mild Traumatic Brain Injury, Anxiety
- Being tested
- TOR-C 1, TOR-C 2
- Keywords
- MTBI - Mild Traumatic Brain Injury, Anxiety, Mindfulness
- Medical subject headings
- Brain Concussion, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOR-C 1Behavioural
TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
TOR-C 2Behavioural
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
| Study group | Role | What they receive |
|---|---|---|
| TOR-C 1 | Experimental | TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice. Receives: Behavioral: TOR-C 1 |
| TOR-C 2 | Active comparator | TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions. Receives: Behavioral: TOR-C 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)
Assessed using the Credibility and Expectancy Questionnaire (CEQ) which asks the participant indicate how much they believe, right now, that the intervention they will receive will help manage their concussion and related worry. Possible scores on both the credibility and expectancy subscales range from 3 to 27 and have a midpoint score of 14. The number of participants that scored at or above 14 on the credibility and/or expectancy subscales are reported below.
Measured: Baseline (0 Weeks)
Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Measured: Post-Test (4 Weeks)
Feasibility of Recruitment
Rate at which recruitment was possible
Measured: Baseline (0 Weeks)
Acceptability of Treatment
Rate at which program was accepted, measured by attendance.
Measured: Post-Test (4 Weeks)
Adherence to Homework
Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study.
Measured: Collected during intervention, an average of 4 weeks
Therapist Adherence
Rate of interventionist's delivering the programs by following the established session topics and practices
Measured: Collected during intervention, an average of 4 weeks
Feasibility of Assessments at Baseline
Rate of participant's completion of self-report measures, with no measures missing
Measured: Baseline (0 Weeks)
Feasibility of Assessments at Post-Test
Rate of participant's completion of self-report measures, with no measures missing
Measured: Post-Test (4 Weeks)
Feasibility of Assessments at Follow-up
Rate of participant's completion of self-report measures, with no measures missing
Measured: Follow-up (12 Weeks)
Adverse Events
Any self reported or observed negative events related to participation
Measured: Collected during intervention, an average of 4 weeks
Secondary outcomes (10)
Numerical Rating Scale
Rate of a participant's pain at rest and with activity using a Likert scale with 0 being no pain and 10 being worst possible pain.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Post-Concussion Symptom Scale (PCSS)
The PCSS measures post-concussion symptoms on a 1-6-point Linkert scale. Higher scores represent greater symptom severity and total scores can range from 22 to132 points.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Generalized Anxiety Disorder Scale (GAD-7)
7-item questionnaire measuring symptoms of anxiety within the past 2 weeks on a scale of 0 to 3. Total scores range from 0 to 21 and higher scores indicate more symptoms of anxiety.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Hospital Anxiety And Depression Scale (HADS)
Measures symptoms of emotional distress and estimates diagnoses. The scale has 14 items, 7 assess anxiety and 7 depression. Scores range from 0-21 on each subscale, wtih higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)
The WHODAS 2.0 measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is on the scale is measured 0-4, with total scores ranging from 0 to 48. Higher scores indicate more disability (worse outcomes).
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)
A 16-item questionnaire assessing beliefs about how work and physical activities affect mTBI symptoms, and whether they should be avoided on a scale of 0 to 3. Total scores range from 0 to 48 and higher scores represent higher fear avoidance.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Pain Catastophizing Scale (PCS)
A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Total scores range from 0 to 25 and higher scores indicate higher pain catastrophizing (worse outcomes).
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)
Rate of a participant's broad conceptualization of mindfulness, items range from 1-4 and scores range from 12-48, with higher values reflecting higher levels of mindfulness
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale
A 7-item subscale of the BRIQ measuring "limiting behaviors" (frequency of inactivity). This subscale is rated on a scale of 0 to 4, with total scores ranging from 0 to 28. Higher scores indicate more limiting behavior (worse outcomes).
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale
A 6-item subscale of the BRIQ measuring "all or nothing behaviors" (tendency for overexertion). This subscale is rated on a scale of 0 to 4, with higher scores indicating more all or nothing behavior. Total scores on this subscale range from 0 to 24.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start15 Oct 2022
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MTBI - Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jonathan Greenberg, Massachusetts General Hospital
- Investigators
- Jonathan Greenberg, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524402
- Sponsor's protocol ID
- 2022P001521
- Other IDs
- K23AT010653-01A1
- Status last verified
- Mar 2025
- First submitted
- 17 Aug 2022
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenberg J, Singh T, Iverson GL, Silverberg ND, Macklin EA, Parker RA, Giacino JT, Yeh GY, Vranceanu AM. A Live Video Mind-Body Treatment to Prevent Persistent Symptoms Following Mild Traumatic Brain Injury: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Jan 14;10(1):e25746. doi: 10.2196/25746.
PubMed 33443484Greenberg J, Levey NS, Becker M, Yeh GY, Giacino JT, Iverson G, Silverberg ND, Parker RA, Vranceanu AM. Feasibility Randomized Controlled Trial of the Toolkit for Optimal Recovery After Concussion: A Live Video Program to Prevent Persistent Concussion Symptoms in Young Adults With Anxiety. Arch Phys Med Rehabil. 2025 Apr;106(4):527-536. doi: 10.1016/j.apmr.2024.10.011. Epub 2024 Nov 5.
PubMed 39505248
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
- ClinicalTrials.gov ID
- NCT05524402
- Acronym / sponsor ID
- 2022P001521
- Conditions
- MTBI - Mild Traumatic Brain Injury, Anxiety
- Keywords
- MTBI - Mild Traumatic Brain Injury, Anxiety, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Posted 20 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom).
Detailed description
The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom).
Each program will consist of four 45-minute sessions over the secure Zoom platform. Participants will receive a treatment manual. There are 3 assessment points consisting of self-report surveys: baseline, post program, and 3-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOR-C 1 | Experimental | Behavioral: TOR-C 1TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice. |
| TOR-C 2 | Active comparator | Behavioral: TOR-C 2TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female outpatients, ages 18-35
- English fluency and literacy
- Diagnosed with a concussion in the past 10 weeks
- Owns a smartphone or computer with Internet access
- Willingness and ability to participate in four 45-minute program sessions and answer remote questionnaires before, after, and 3-month following the program
Key exclusion criteria (8 listed)
- Previous history of moderate or severe TBI OR concussion in the past 2 years that resulted in symptoms lasting 3 months or more
- Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)
- Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder
- Current substance abuse or dependence and current substance use disorder
- Current active self-reported suicidal ideation
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 |
|---|---|---|
| TOR-C 1TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice. | Behavioural | TOR-C 1 |
| TOR-C 2TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions. | Behavioural | TOR-C 2 |
Primary outcome
Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)
Time frame: Baseline (0 Weeks)
Assessed using the Credibility and Expectancy Questionnaire (CEQ) which asks the participant indicate how much they believe, right now, that the intervention they will receive will help manage their concussion and related worry. Possible scores on both the credibility and expectancy subscales range from 3 to 27 and have a midpoint score of 14. The number of participants that scored at or above 14 on the credibility and/or expectancy subscales are reported below.
Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
Time frame: Post-Test (4 Weeks)
Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Feasibility of Recruitment
Time frame: Baseline (0 Weeks)
Rate at which recruitment was possible
Acceptability of Treatment
Time frame: Post-Test (4 Weeks)
Rate at which program was accepted, measured by attendance.
Adherence to Homework
Time frame: Collected during intervention, an average of 4 weeks
Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study.
Therapist Adherence
Time frame: Collected during intervention, an average of 4 weeks
Rate of interventionist's delivering the programs by following the established session topics and practices
Feasibility of Assessments at Baseline
Time frame: Baseline (0 Weeks)
Rate of participant's completion of self-report measures, with no measures missing
Feasibility of Assessments at Post-Test
Time frame: Post-Test (4 Weeks)
Rate of participant's completion of self-report measures, with no measures missing
Feasibility of Assessments at Follow-up
Time frame: Follow-up (12 Weeks)
Rate of participant's completion of self-report measures, with no measures missing
Adverse Events
Time frame: Collected during intervention, an average of 4 weeks
Any self reported or observed negative events related to participation
10 secondary outcomes
Numerical Rating Scale
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Post-Concussion Symptom Scale (PCSS)
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Hospital Anxiety And Depression Scale (HADS)
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Pain Catastophizing Scale (PCS)
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33443484Greenberg J, Singh T, Iverson GL, Silverberg ND, Macklin EA, Parker RA, Giacino JT, Yeh GY, Vranceanu AM. A Live Video Mind-Body Treatment to Prevent Persistent Symptoms Following Mild Traumatic Brain Injury: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Jan 14;10(1):e25746. doi: 10.2196/25746.
- Derived from this study: PubMed 39505248Greenberg J, Levey NS, Becker M, Yeh GY, Giacino JT, Iverson G, Silverberg ND, Parker RA, Vranceanu AM. Feasibility Randomized Controlled Trial of the Toolkit for Optimal Recovery After Concussion: A Live Video Program to Prevent Persistent Concussion Symptoms in Young Adults With Anxiety. Arch Phys Med Rehabil. 2025 Apr;106(4):527-536. doi: 10.1016/j.apmr.2024.10.011. Epub 2024 Nov 5.
- 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.
Jonathan Greenberg, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOR-C 1 and TOR-C 2 in people with MTBI - Mild Traumatic Brain Injury and Anxiety, run by Massachusetts General Hospital 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 7 inclusion and 8 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 20 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ) (time frame: Baseline (0 Weeks)). The study lists 10 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 NCT05524402, which also lists 2 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 20 Mar 2025.