Posttraumatic Stress DisorderNCT05892276
Effects of CBD Oil on Memory Reconsolidation and Trauma-Related Symptoms
A study testing Trauma Memory Reactivation and Cannabidiol (CBD) Broad-Spectrum Oil in people with Posttraumatic Stress Disorder, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of cannabidiol (CBD) broad-spectrum oil on memory reconsolidation (memory storage) and trauma-related symptoms in trauma-exposed individuals after exposure to a trauma memory reactivation paradigm. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Trauma Memory Reactivation and Cannabidiol (CBD) Broad-Spectrum Oil
- Type of treatment
- Pill or oral medicine, 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
- 31 Aug 2024to 31 Aug 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 to 65;
- Fluent in written and spoken English;
- Has access to the internet;
- Access to a camera with video recording capability;
- History of trauma exposure to either a motor vehicle collision (MVC), sexual assault, physical assault, or combat;
- Willingness to refrain from all non-study cannabis use during the study period
Who cannot join
- Insufficient emotional reactivity to trauma video clips
- Presence of significant suicidality or a history of a suicide attempt within the past 6 months;
- History or current alcohol or substance use disorder within the past month;
- History of psychosis within the past 6 months;
- Changes in psychotropic medication (≤ 8 weeks);
- Currently receiving trauma-focused psychotherapy;
Show all 12Show fewer
- Any medical problem that would preclude participation in the study (e.g., liver or renal abnormalities or disease);
- Any current medication that would preclude participation in the study (e.g., use of prescribed blood, such as warfarin; use of anti-seizure medications, such as valproate, lamotrigine, or clobazam; use of thyroid medications, such as levothyroxine; use of heart rhythm medications, such as amiodarone);
- Pregnant or planning to become pregnant within the next 6 weeks;
- Regular cannabis use;
- History of adverse reaction to CBD oil or other CBD products;
- Allergy to coconut or coconut oil
Trial locations and contacts
1 site in 1 country.
United States1 site
The Laboratory for the Study of Anxiety Disorders, The University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: Effects of Cannabidiol on Memory Reconsolidation and Trauma-Related Symptoms: A Randomized Clinical Trial
The purpose of this study is to investigate the effects of cannabidiol (CBD) broad-spectrum oil on memory reconsolidation (memory storage) and trauma-related symptoms in trauma-exposed individuals after exposure to a trauma memory reactivation paradigm.
Read the detailed description
It is estimated that over 70% of individuals worldwide have experienced a trauma during their lifetime. Many people spontaneously recover without formal intervention or treatment after exposure to a traumatic event; however, some individuals may develop intrusive trauma-related memories, avoidance, negative changes in cognition or mood, or changes in arousal and reactivity, resulting in clinical or subclinical symptoms of posttraumatic stress disorder (PTSD).
Recently, the potential therapeutic effects of cannabidiol (CBD) have been investigated as a treatment for physical and mental health issues. Preclinical trials with rodents suggest that CBD may disrupt the reconsolidation of conditioned fear memories when administered within the six-hour memory reconsolidation window. These preclinical findings suggest that CBD may be clinically useful for preventing or treating PTSD. Although promising, little translational research has investigated the disruptive effects of CBD on memory reconsolidation in a trauma-exposed human population.
The overarching objective of this study is to investigate the effects of CBD broad-spectrum oil on memory reconsolidation and trauma-related symptoms in trauma-exposed individuals after exposure to a trauma memory reactivation procedure. To accomplish this, participants will be randomized to one of three treatment conditions: (a) CBD oil administered within the reconsolidation window (CBD-WR), (b) placebo oil administered within the reconsolidation window (PBO-WR), or (c) CBD oil administered well outside of the accepted memory reconsolidation window (CBD-OR). Participants will undergo a trauma memory reactivation paradigm, rate their emotional distress level, and complete other trauma-related measures.
To the best of our knowledge, this is the first clinical trial to investigate the effects of CBD broad-spectrum oil on memory reconsolidation and trauma-related symptoms among trauma-exposed individuals following exposure to a trauma memory reactivation paradigm. Additionally, this proof-of-concept pilot trial aims to contribute to the development of a novel, brief, packageable, and cost-effective secondary prevention or treatment for individuals with trauma-related fear memories and symptoms of trauma.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Trauma Memory Reactivation, Cannabidiol (CBD) Broad-Spectrum Oil, Placebo Oil
- Keywords
- Cannabidiol, CBD, PTSD, Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Memory ReactivationBehavioural
Participants will be guided through the trauma memory reactivation paradigm by the study staff. The trauma memory reactivation paradigm entails two distinct procedures: (1) participants will watch a video clip related to their trauma; then (2) describe a verbal narrative of their traumatic event for approximately 5 minutes to a research team member.
Cannabidiol (CBD) Broad-Spectrum OilDietary supplement
300mg CBD broad-spectrum oil.
Placebo OilDietary supplement
3ml oral dose of medium-chain triglycerides (MCT) coconut oil.
| Study group | Role | What they receive |
|---|---|---|
| CBD-WR | Experimental | 300 mg CBD broad-spectrum oil will be administered within the reconsolidation window.
Preclinical studies demonstrate that the disruptive effects of CBD oil on memory reconsolidation depend on the timing of pharmacological administration (within 6 hours of memory reactivation).
Thus, participants will be asked to take a single 300mg oral dose of CBD broad-spectrum oil immediately after the trauma memory reactivation procedure. Receives: Behavioral: Trauma Memory Reactivation; Dietary Supplement: Cannabidiol (CBD) Broad-Spectrum Oil |
| PBO-WR | Placebo comparator | Placebo oil will be administered within the reconsolidation window.
Participants will be asked to take a single dose of an MCT coconut oil placebo solution immediately after the trauma memory reactivation procedure. Receives: Behavioral: Trauma Memory Reactivation; Dietary Supplement: Placebo Oil |
| CBD-OR | Active comparator | 300mg CBD broad-spectrum oil will be administered outside of the reconsolidation window.
Participants will be asked to take a single 300mg oral dose of CBD broad-spectrum oil approximately 24 hrs after the trauma memory reactivation procedure.
Thus, CBD will be administered well beyond the critical period for memory reconsolidation. The inclusion of this third arm provides a more robust test of the specific reconsolidation theory-based study hypotheses and aids in controlling for any nonspecific possible anxiolytic effects of CBD. Receives: Behavioral: Trauma Memory Reactivation; Dietary Supplement: Cannabidiol (CBD) Broad-Spectrum Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Momentary Assessment of Distress Scale
The Momentary Assessment of Distress Scale (MADS) is a customizable sliding scale used to measure continuous real-time changes in levels of subjective emotional stress on scale from 0 (no distress) to 10 (extreme distress). The MADS is used to index changes in emotional reactivity during exposure to a trauma memory reactivation cue.
Measured: Change from Baseline to Two-week Follow-up
Secondary outcomes (6)
Posttraumatic Stress Disorder Checklist
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire that assesses symptoms consistent with the DSM-5 diagnosis of PTSD. Respondents rate the frequency of each symptom over the last month utilizing a 5-point scale (0 indicating "not at all"; 4 indicating "extremely").
Measured: Change from Baseline to Two-week Follow-up
Posttraumatic Cognition Inventory
The Brief Version of the Posttraumatic Cognitions Inventory (PTCI-9) is a 9-item questionnaire that assesses negative posttraumatic cognition. Items are rated on a 7-point Likert scale with 1 indicating "Totally disagree" and 7 indicating "Totally agree." The instrument consists of three subscales (self-blame, negative cognitions of the self, and negative cognitions of the world) to yield the total and subscale scores, with higher scores indicating more negative posttraumatic cognitions.
Measured: Change from Baseline to Two-week Follow-up
Posttraumatic Safety Behaviors Inventory
The Posttraumatic Safety Behavior Inventory (PSBI) is a 13-item self-report questionnaire that assesses safety behaviors related to PTSD. Items are rated on a 5-point scale with 0 indicating "Never" and 4 indicating "Always." The first 10 items of the inventory yield a summed total score. The last three items of the inventory are open-ended to record safety behavior specific to the respondent and can be used in clinical applications. Higher scores suggest more engagement with PTSD safety behaviors.
Measured: Change from Baseline to Two-week Follow-up
Posttraumatic Growth Inventory
The Posttraumatic Growth Inventory (PGTI) is a 21-item self-report scale that measures positive outcomes associated with traumatic events. Items are rated on a 6-point scale with 0 indicating "I did not experience this as a result of my crisis" and 5 indicating "I experienced this change to a very great degree as a result of my crisis." The inventory is comprised of five factors (appreciation of life relating to others, spiritual change, new possibilities, and personal strength).
Measured: Change from Baseline to Two-week Follow-up
Trauma Coping Self-Efficacy Scale
The Trauma Coping Self-Efficacy (CSE-T) Scale - 9-item is a brief self-report scale that assesses perceptions of coping self-efficacy following a traumatic experience. Respondents rate their perceived capacity to handle demands related to their trauma on a 7-point scale (1 indicating "Not at all capable"; 7 indicating "Totally capable").
Measured: Change from Baseline to Two-week Follow-up
Connor-Davidson Resilience Scale
The Connor-Davidson Resilience Scale - 10 item (CD-RISC-10) is a 10-item self-report questionnaire that assesses resilience (e.g., the ability to cope with adverse experiences). Respondents rate items utilizing a 5-point scale (0 indicating "not true at all"; 4 indicating "true nearly all the time"). The summation of all items yields a total score, ranging from 0 to 40, with higher scores suggesting greater resilience.
Measured: Change from Baseline to Two-week Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start31 Aug 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Why it stopped: The UT IRB determined that CBD oil is being used as a drug as defined by the FDA. Therefore, an IND must be obtained for the use of CBD oil in this research study in accordance with FDA regulations, 21 CFR 312.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Telch, University of Texas at Austin
- Investigators
- Michael J Telch, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892276
- Sponsor's protocol ID
- STUDY00004278
- Status last verified
- Jan 2024
- First submitted
- 15 May 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kessler RC, Aguilar-Gaxiola S, Alonso J, Benjet C, Bromet EJ, Cardoso G, Degenhardt L, de Girolamo G, Dinolova RV, Ferry F, Florescu S, Gureje O, Haro JM, Huang Y, Karam EG, Kawakami N, Lee S, Lepine JP, Levinson D, Navarro-Mateu F, Pennell BE, Piazza M, Posada-Villa J, Scott KM, Stein DJ, Ten Have M, Torres Y, Viana MC, Petukhova MV, Sampson NA, Zaslavsky AM, Koenen KC. Trauma and PTSD in the WHO World Mental Health Surveys. Eur J Psychotraumatol. 2017 Oct 27;8(sup5):1353383. doi: 10.1080/20008198.2017.1353383. eCollection 2017.
PubMed 29075426Murkar A, Kent P, Cayer C, James J, Durst T, Merali Z. Cannabidiol and the Remainder of the Plant Extract Modulate the Effects of Delta9-Tetrahydrocannabinol on Fear Memory Reconsolidation. Front Behav Neurosci. 2019 Aug 1;13:174. doi: 10.3389/fnbeh.2019.00174. eCollection 2019.
PubMed 31417379Stern CAJ, de Carvalho CR, Bertoglio LJ, Takahashi RN. Effects of Cannabinoid Drugs on Aversive or Rewarding Drug-Associated Memory Extinction and Reconsolidation. Neuroscience. 2018 Feb 1;370:62-80. doi: 10.1016/j.neuroscience.2017.07.018. Epub 2017 Jul 17.
PubMed 28729064
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabidiol on Memory Reconsolidation and Trauma-Related Symptoms: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05892276
- Acronym / sponsor ID
- STUDY00004278
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Cannabidiol, CBD, PTSD, Trauma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The UT IRB determined that CBD oil is being used as a drug as defined by the FDA. Therefore, an IND must be obtained for the use of CBD oil in this research study in accordance with FDA regulations, 21 CFR 312.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 31 Aug 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 7 Jun 2023 (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 purpose of this study is to investigate the effects of cannabidiol (CBD) broad-spectrum oil on memory reconsolidation (memory storage) and trauma-related symptoms in trauma-exposed individuals after exposure to a trauma memory reactivation paradigm.
Detailed description
It is estimated that over 70% of individuals worldwide have experienced a trauma during their lifetime. Many people spontaneously recover without formal intervention or treatment after exposure to a traumatic event; however, some individuals may develop intrusive trauma-related memories, avoidance, negative changes in cognition or mood, or changes in arousal and reactivity, resulting in clinical or subclinical symptoms of posttraumatic stress disorder (PTSD).
Recently, the potential therapeutic effects of cannabidiol (CBD) have been investigated as a treatment for physical and mental health issues. Preclinical trials with rodents suggest that CBD may disrupt the reconsolidation of conditioned fear memories when administered within the six-hour memory reconsolidation window. These preclinical findings suggest that CBD may be clinically useful for preventing or treating PTSD. Although promising, little translational research has investigated the disruptive effects of CBD on memory reconsolidation in a trauma-exposed human population.
The overarching objective of this study is to investigate the effects of CBD broad-spectrum oil on memory reconsolidation and trauma-related symptoms in trauma-exposed individuals after exposure to a trauma memory reactivation procedure. To accomplish this, participants will be randomized to one of three treatment conditions: (a) CBD oil administered within the reconsolidation window (CBD-WR), (b) placebo oil administered within the reconsolidation window (PBO-WR), or (c) CBD oil administered well outside of the accepted memory reconsolidation window (CBD-OR). Participants will undergo a trauma memory reactivation paradigm, rate their emotional distress level, and complete other trauma-related measures.
To the best of our knowledge, this is the first clinical trial to investigate the effects of CBD broad-spectrum oil on memory reconsolidation and trauma-related symptoms among trauma-exposed individuals following exposure to a trauma memory reactivation paradigm. Additionally, this proof-of-concept pilot trial aims to contribute to the development of a novel, brief, packageable, and cost-effective secondary prevention or treatment for individuals with trauma-related fear memories and symptoms of trauma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBD-WR | Experimental | Behavioral: Trauma Memory Reactivation, Dietary Supplement: Cannabidiol (CBD) Broad-Spectrum Oil300 mg CBD broad-spectrum oil will be administered within the reconsolidation window. Preclinical studies demonstrate that the disruptive effects of CBD oil on memory reconsolidation depend on the timing of pharmacological administration (within 6 hours of memory reactivation). Thus, participants will be asked to take a single 300mg oral dose of CBD broad-spectrum oil immediately after the trauma memory reactivation procedure. |
| PBO-WR | Placebo comparator | Behavioral: Trauma Memory Reactivation, Dietary Supplement: Placebo OilPlacebo oil will be administered within the reconsolidation window. Participants will be asked to take a single dose of an MCT coconut oil placebo solution immediately after the trauma memory reactivation procedure. |
| CBD-OR | Active comparator | Behavioral: Trauma Memory Reactivation, Dietary Supplement: Cannabidiol (CBD) Broad-Spectrum Oil300mg CBD broad-spectrum oil will be administered outside of the reconsolidation window. Participants will be asked to take a single 300mg oral dose of CBD broad-spectrum oil approximately 24 hrs after the trauma memory reactivation procedure. Thus, CBD will be administered well beyond the critical period for memory reconsolidation. The inclusion of this third arm provides a more robust test of the specific reconsolidation theory-based study hypotheses and aids in controlling for any nonspecific possible anxiolytic effects of CBD. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults age 18 to 65;
- Fluent in written and spoken English;
- Has access to the internet;
- Access to a camera with video recording capability;
- History of trauma exposure to either a motor vehicle collision (MVC), sexual assault, physical assault, or combat;
Key exclusion criteria (12 listed)
- Insufficient emotional reactivity to trauma video clips
- Presence of significant suicidality or a history of a suicide attempt within the past 6 months;
- History or current alcohol or substance use disorder within the past month;
- History of psychosis within the past 6 months;
- Changes in psychotropic medication (≤ 8 weeks);
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 |
|---|---|---|
| Trauma Memory ReactivationParticipants will be guided through the trauma memory reactivation paradigm by the study staff. The trauma memory reactivation paradigm entails two distinct procedures: (1) participants will watch a video clip related to their trauma; then (2) describe a verbal narrative of their traumatic event for approximately 5 minutes to a research team member. | Behavioural | CBD-OR, CBD-WR, PBO-WR |
| Cannabidiol (CBD) Broad-Spectrum Oil300mg CBD broad-spectrum oil. | Dietary supplement | CBD-OR, CBD-WR |
| Placebo Oil3ml oral dose of medium-chain triglycerides (MCT) coconut oil. | Dietary supplement | PBO-WR |
Primary outcome
Momentary Assessment of Distress Scale
Time frame: Change from Baseline to Two-week Follow-up
The Momentary Assessment of Distress Scale (MADS) is a customizable sliding scale used to measure continuous real-time changes in levels of subjective emotional stress on scale from 0 (no distress) to 10 (extreme distress). The MADS is used to index changes in emotional reactivity during exposure to a trauma memory reactivation cue.
6 secondary outcomes
Posttraumatic Stress Disorder Checklist
Time frame: Change from Baseline to Two-week Follow-up
Posttraumatic Cognition Inventory
Time frame: Change from Baseline to Two-week Follow-up
Posttraumatic Safety Behaviors Inventory
Time frame: Change from Baseline to Two-week Follow-up
Posttraumatic Growth Inventory
Time frame: Change from Baseline to Two-week Follow-up
Trauma Coping Self-Efficacy Scale
Time frame: Change from Baseline to Two-week Follow-up
Connor-Davidson Resilience Scale
Time frame: Change from Baseline to Two-week Follow-up
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 9 Jan 2024.
- Background: PubMed 29075426Kessler RC, Aguilar-Gaxiola S, Alonso J, Benjet C, Bromet EJ, Cardoso G, Degenhardt L, de Girolamo G, Dinolova RV, Ferry F, Florescu S, Gureje O, Haro JM, Huang Y, Karam EG, Kawakami N, Lee S, Lepine JP, Levinson D, Navarro-Mateu F, Pennell BE, Piazza M, Posada-Villa J, Scott KM, Stein DJ, Ten Have M, Torres Y, Viana MC, Petukhova MV, Sampson NA, Zaslavsky AM, Koenen KC. Trauma and PTSD in the WHO World Mental Health Surveys. Eur J Psychotraumatol. 2017 Oct 27;8(sup5):1353383. doi: 10.1080/20008198.2017.1353383. eCollection 2017.
- Background: PubMed 31417379Murkar A, Kent P, Cayer C, James J, Durst T, Merali Z. Cannabidiol and the Remainder of the Plant Extract Modulate the Effects of Delta9-Tetrahydrocannabinol on Fear Memory Reconsolidation. Front Behav Neurosci. 2019 Aug 1;13:174. doi: 10.3389/fnbeh.2019.00174. eCollection 2019.
- Background: PubMed 28729064Stern CAJ, de Carvalho CR, Bertoglio LJ, Takahashi RN. Effects of Cannabinoid Drugs on Aversive or Rewarding Drug-Associated Memory Extinction and Reconsolidation. Neuroscience. 2018 Feb 1;370:62-80. doi: 10.1016/j.neuroscience.2017.07.018. Epub 2017 Jul 17.
- 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.
Michael J Telch, Ph.D. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Memory Reactivation and Cannabidiol (CBD) Broad-Spectrum Oil in people with Posttraumatic Stress Disorder, run by University of Texas at Austin 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 6 inclusion and 12 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 9 Jan 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?
Momentary Assessment of Distress Scale (time frame: Change from Baseline to Two-week Follow-up). 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 NCT05892276, which also lists 3 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 9 Jan 2024.