Stress Disorders, Post-TraumaticPhase 4NCT05853627
Mismatch vs. Standard Intervention During Memory Reconsolidation Blockade With Propranolol: Effect on Psychophysiological Reactivity During Traumatic Imagery
A Phase 4 study testing Memory reactivation procedures and Propranolol in people with Stress Disorders, Post-Traumatic, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The proposed R21 project will attempt to further develop a novel intervention for posttraumatic stress symptoms inspired by the science of memory reconsolidation. Work in normal humans has shown that when a stable, consolidated memory is reactivated (i.e., retrieved) under appropriate conditions, it reverts to an… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Memory reactivation procedures and Propranolol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Initial participants will be males or females 18-65 years old who have experienced a traumatic event that meets the DSM-5 PTSD A criterion, and whose PCL-5 score is >33 (to maximize the likelihood that they will meet our psychophysiological inclusion criterion). In order to be randomized, participants must further meet this psychophysiological inclusion criterion during baseline script-driven imagery testing Although we do not require a diagnosis of PTSD, because we have set a minimum psychophysiological inclusion criterion and a valid Criterion A traumatic event, our sample will include a substantial number, likely a majority, of PTSD participants.
Who cannot join
- Basal sitting or standing systolic blood pressure <90/60 mm Hg or basal HR <50 BPM. Those participant-candidates excluded for this reason with such readings will be counseled and referred for further clinical consultation if symptomatic or if they wish to be referred even if asymptomatic.
- Medical condition that contraindicates PPNL, e.g., congestive heart failure, heart block, insulin- requiring diabetes, chronic bronchitis, emphysema, or asthma. Asthma attacks will only be exclusionary if they: a) occurred within the past ten years, b) occurred at any time in life if induced by a β-blocker, or c) are currently being treated
- Previous adverse reaction to, or non-compliance with, a β-blocker
- Current use of medication that may involve potentially dangerous or confounding interactions with PPNL, including anti- hypertensives, antiarrhythmics, and benzodiazepines. (Possible inhibition of CYP2D6 isoenzyme-dependent reactions will not be of concern in this study, because PPNL will only be administered once a week)
- Presence of drugs of abuse, including opiates, marijuana, cocaine, amphetamines, or alcohol at the initial assessment
- Pregnancy or breast feeding. Women of childbearing potential will have a pregnancy test at the initial assessment
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- Presence of a contraindicating psychiatric condition, e.g., psychotic, bipolar, melancholic, or active substance use disorder; or suicidality (see below)
- Initiation of, or change in, psychotropic medication within the previous two months. For participants receiving stable doses of pharmacotherapy, they and their clinicians-prescribers will be asked not to alter the regimen during the proposed two-month study period (excluding the one-month follow-up) except in clinically urgent circumstances. If this becomes necessary, a decision will be made on a case-by-case basis about retaining the participant or terminating participation
- Current participation in any psychotherapy other than supportive. Participants will be asked not to initiate new psychotherapy during the proposed two-month study period (excluding the one-month follow-up) except in clinically urgent circumstances. If this becomes necessary, a decision will be made on a case-by-case basis about retaining the participant or terminating participation
- Inability to understand the study's procedures, risks, and side effects, or to otherwise give informed consent for participation
- Participant candidate does not understand English. This exclusion criterion is necessary because the procedures require a nuanced dialogue with English-speaking investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital Home Base Program
Charlestown, Massachusetts, 02129
Kaloyan Tanev, MD, 617-764-6476, ktanev@bwh.harvard.edu
Oren Bazer, BA, 774-279-7599, obazer@mgh.harvard.edu
About this study
The proposed R21 project will attempt to further develop a novel intervention for posttraumatic stress symptoms inspired by the science of memory reconsolidation. Work in normal humans has shown that when a stable, consolidated memory is reactivated (i.e., retrieved) under appropriate conditions, it reverts to an unstable state, a process referred to herein as deconsolidation. In such a state, the memory is susceptible to the action of various "amnestic" agents that may inhibit its reconsolidation, thereby weakening it. The β-adrenergic blocker propranolol (PPNL) possesses such amnestic properties. More recent research has found that in order to initiate deconsolidation, there must be a prediction error, or mismatch, between what is expected and what occurs when the memory is reactivated.
Prior placebo-controlled, randomized clinical trials (PBO-RCT) from our laboratory have found that when propranolol is administered concomitant with the reactivation of a psychologically traumatic memory, the memory is weakened, as revealed by subsequent lower physiological (heart rate, skin conductance, facial electromyogram) responding during script-driven mental imagery. Clinical applicability was evaluated in a PBO-RCT, in which PTSD participants receiving propranolol underwent six weekly sessions of 10-20 min of "standard" (STD) traumatic memory reactivation stimulated by reading a narrative. At post-treatment, these participants showed a greater reduction of PTSD symptoms compared to participants who had taken PBO. The goal of the proposed study is to test whether intentionally incorporating innovative mismatch (MM) into traumatic memory reactivation can improve upon physiological responding during script-driven mental imagery.
Participants will be randomized to one of 2 treatment arms: STD/PPNL and MM/PPNL. A baseline assessment will measure psychophysiological responsivity to script-driven mental imagery (target measure). PPNL will be administered 90-min prior to each of six weekly 10-20 min. traumatic memory reactivation sessions. In the MM condition, a different, unexpected mismatch (e.g., singing the narrative) will be incorporated into the reactivation. In the STD condition, the participant will read the narrative the same way each time. The focus of the R21 proposal will be to assess whether the MM/PPNL group shows lower subsequent physiological responses than the STD/PPNL group
Read the detailed description
The proposed project under the R21 Basic Experimental Studies Involving Humans (BESH) mechanism aims to test whether adding 'mismatch' (MM) to traumatic memory reactivation under the influence of the beta-(nor)adrenergic blocker propranolol (PPNL), compared to no mismatch reactivation, further reduces physiological reactivity during script driven imagery of the traumatic event. We propose that the mechanism for the propranolol MM treatment is a) deconsolidation of the traumatic memory instigated by MM, followed by b) blockade of the reconsolidation of the memory by the amnestic agent PPNL. The efficacy of the MM intervention will be contrasted with a standard (STD) reactivation condition that does not include an intentional MM component. We will randomize individuals who have experienced a traumatic event and meet our entry criteria (please see research strategy) to one of the two treatment arms: STD/PPNL and MM/PPNL. Participants' psychophysiological (heart rate, skin conductance, corrugator electromyogram (EMG)) responses during script driven imagery of their traumatic event will constitute the R21 target.
On the initial assessment day, participant candidates will be screened for eligibility based upon the inclusion/exclusion criteria. After the candidate provides written informed consent, a doctoral-level clinician will administer the psychometric instruments. Participant candidates will complete a narrative describing the traumatic event that caused PTSD.
Based on the narrative, the psychologist will then prepare a 100-word script portraying the most salient aspect ("hot spot") of the narrative, which will be recorded for audio playback in the psychophysiology laboratory. Participants not physiologically reactive to the traumatic script will be excluded. If all of the foregoing is completed successfully, participants will be randomized to one of the two arms above.
The participant will return to the clinic one week later for the first of six weekly intervention sessions. Ninety min. prior to its commencement, the participant will ingest the study medication. The participant will then recite the narrative aloud for 10-20 min. In the STD condition, the participant will recite the narrative in an expected manner, i.e., in the same way during each session. In the MM condition, the participant will recite the narrative in an unexpected manner, different for each weekly session. Examples of unexpected conditions will include such things as reciting their narrative while skipping over each word that contains the letter "e", and reciting the narrative in a make-believe accent. A week following the final intervention session, the participant will return for the post-treatment psychophysiological testing. These will be repeated at the one-month follow-up session.
The data will be analyzed by hierarchical linear modeling and regression techniques. The projected sample sizes will provide adequate power to test the proposed study's hypotheses (see Design and Power Analysis section).
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Memory reactivation procedures, Propranolol
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory reactivation proceduresBehavioural
In the Mismatch condition, a different, unexpected mismatch will be incorporated into the reactivation. In the Standard condition, the participant will read the narrative the same way each time.
PropranololDrug
Propranolol will be administered 60-min prior to each of six weekly 10-20 min. traumatic memory reactivation sessions.
| Study group | Role | What they receive |
|---|---|---|
| Mismatch reactivation condition | Experimental | The participant will recite their trauma narrative to the psychologist for 10-20 minutes. However, during each recitation, a "mismatch" condition, different for each session, will be added to the reactivation procedure by having the participant do the following (in order of sessions. Receives: Behavioral: Memory reactivation procedures; Drug: Propranolol |
| Standard reactivation condition | Active comparator | The intervention will be the same for each of the six intervention sessions. The participant will recite to the psychologist the narrative they previously composed for 10-20 min. The psychologist will congratulate the participant for having succeeded in this task and advise them they are finished for the day. Receives: Behavioral: Memory reactivation procedures; Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score of psychophysiological reactivity (comprising heart rate, skin conductance, and electromyography of the left corrugator muscle) using the Biopac system.
psychophysiological responding during script-driven traumatic imagery compared to no imagery.
Measured: Baseline (week 0)
Composite score of psychophysiological reactivity (comprising heart rate, skin conductance, and electromyography of the left corrugator muscle) using the Biopac system.
psychophysiological responding during script-driven traumatic imagery compared to no imagery.
Measured: Post-treatment (week 7)
Composite score of psychophysiological reactivity (comprising heart rate, skin conductance, and electromyography of the left corrugator muscle) using the Biopac system.
psychophysiological responding during script-driven traumatic imagery compared to no imagery.
Measured: Follow up (week 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start15 Jun 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The efficacy of the MM intervention will be contrasted with a standard (STD) reactivation condition that does not include an intentional MM component. We will randomize ndividuals who have experienced a traumatic event and meet our entry criteria (please see research strategy) to one of the two treatment arms: STD/PPNL and MM/PPNL. Participants' psychophysiological (heart rate, skin conductance, corrugator electromyogram (EMG)) responses during script driven imagery of their traumatic event will constitute the R21 target.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaloyan Tanev, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853627
- Sponsor's protocol ID
- 1R21MH131987-01A1
- Status last verified
- May 2026
- First submitted
- 20 Apr 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No subject identifiers will be released. The results of this study will be shared with the wider scientific community. Data will be stored in the NIMH Data Archive (NDA), where it will be available for secondary analysis. Data will be findable by the research community through the NDA Collection that will be established when this application is funded. The data will be uploaded on a rolling basis and brought current twice annually following the usual NDA data submission dates. To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. For all publications, an NDA study will be created. Each of these studies will be assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mismatch vs. Standard Intervention During Memory Reconsolidation Blockade With Propranolol: Effect on Psychophysiological Reactivity During Traumatic Imagery
- ClinicalTrials.gov ID
- NCT05853627
- Acronym / sponsor ID
- 1R21MH131987-01A1
- Conditions
- Stress Disorders, Post-Traumatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 11 May 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 proposed R21 project will attempt to further develop a novel intervention for posttraumatic stress symptoms inspired by the science of memory reconsolidation. Work in normal humans has shown that when a stable, consolidated memory is reactivated (i.e., retrieved) under appropriate conditions, it reverts to an unstable state, a process referred to herein as deconsolidation. In such a state, the memory is susceptible to the action of various "amnestic" agents that may inhibit its reconsolidation, thereby weakening it. The β-adrenergic blocker propranolol (PPNL) possesses such amnestic properties. More recent research has found that in order to initiate deconsolidation, there must be a prediction error, or mismatch, between what is expected and what occurs when the memory is reactivated.
Prior placebo-controlled, randomized clinical trials (PBO-RCT) from our laboratory have found that when propranolol is administered concomitant with the reactivation of a psychologically traumatic memory, the memory is weakened, as revealed by subsequent lower physiological (heart rate, skin conductance, facial electromyogram) responding during script-driven mental imagery. Clinical applicability was evaluated in a PBO-RCT, in which PTSD participants receiving propranolol underwent six weekly sessions of 10-20 min of "standard" (STD) traumatic memory reactivation stimulated by reading a narrative. At post-treatment, these participants showed a greater reduction of PTSD symptoms compared to participants who had taken PBO. The goal of the proposed study is to test whether intentionally incorporating innovative mismatch (MM) into traumatic memory reactivation can improve upon physiological responding during script-driven mental imagery.
Participants will be randomized to one of 2 treatment arms: STD/PPNL and MM/PPNL. A baseline assessment will measure psychophysiological responsivity to script-driven mental imagery (target measure). PPNL will be administered 90-min prior to each of six weekly 10-20 min. traumatic memory reactivation sessions. In the MM condition, a different, unexpected mismatch (e.g., singing the narrative) will be incorporated into the reactivation. In the STD condition, the participant will read the narrative the same way each time. The focus of the R21 proposal will be to assess whether the MM/PPNL group shows lower subsequent physiological responses than the STD/PPNL group
Detailed description
The proposed project under the R21 Basic Experimental Studies Involving Humans (BESH) mechanism aims to test whether adding 'mismatch' (MM) to traumatic memory reactivation under the influence of the beta-(nor)adrenergic blocker propranolol (PPNL), compared to no mismatch reactivation, further reduces physiological reactivity during script driven imagery of the traumatic event. We propose that the mechanism for the propranolol MM treatment is a) deconsolidation of the traumatic memory instigated by MM, followed by b) blockade of the reconsolidation of the memory by the amnestic agent PPNL. The efficacy of the MM intervention will be contrasted with a standard (STD) reactivation condition that does not include an intentional MM component. We will randomize individuals who have experienced a traumatic event and meet our entry criteria (please see research strategy) to one of the two treatment arms: STD/PPNL and MM/PPNL. Participants' psychophysiological (heart rate, skin conductance, corrugator electromyogram (EMG)) responses during script driven imagery of their traumatic event will constitute the R21 target.
On the initial assessment day, participant candidates will be screened for eligibility based upon the inclusion/exclusion criteria. After the candidate provides written informed consent, a doctoral-level clinician will administer the psychometric instruments. Participant candidates will complete a narrative describing the traumatic event that caused PTSD.
Based on the narrative, the psychologist will then prepare a 100-word script portraying the most salient aspect ("hot spot") of the narrative, which will be recorded for audio playback in the psychophysiology laboratory. Participants not physiologically reactive to the traumatic script will be excluded. If all of the foregoing is completed successfully, participants will be randomized to one of the two arms above.
The participant will return to the clinic one week later for the first of six weekly intervention sessions. Ninety min. prior to its commencement, the participant will ingest the study medication. The participant will then recite the narrative aloud for 10-20 min. In the STD condition, the participant will recite the narrative in an expected manner, i.e., in the same way during each session. In the MM condition, the participant will recite the narrative in an unexpected manner, different for each weekly session. Examples of unexpected conditions will include such things as reciting their narrative while skipping over each word that contains the letter "e", and reciting the narrative in a make-believe accent. A week following the final intervention session, the participant will return for the post-treatment psychophysiological testing. These will be repeated at the one-month follow-up session.
The data will be analyzed by hierarchical linear modeling and regression techniques. The projected sample sizes will provide adequate power to test the proposed study's hypotheses (see Design and Power Analysis section).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The efficacy of the MM intervention will be contrasted with a standard (STD) reactivation condition that does not include an intentional MM component. We will randomize ndividuals who have experienced a traumatic event and meet our entry criteria (please see research strategy) to one of the two treatment arms: STD/PPNL and MM/PPNL. Participants' psychophysiological (heart rate, skin conductance, corrugator electromyogram (EMG)) responses during script driven imagery of their traumatic event will constitute the R21 target.
| Arm | Type | Receives |
|---|---|---|
| Mismatch reactivation condition | Experimental | Behavioral: Memory reactivation procedures, Drug: PropranololThe participant will recite their trauma narrative to the psychologist for 10-20 minutes. However, during each recitation, a "mismatch" condition, different for each session, will be added to the reactivation procedure by having the participant do the following (in order of sessions. |
| Standard reactivation condition | Active comparator | Behavioral: Memory reactivation procedures, Drug: PropranololThe intervention will be the same for each of the six intervention sessions. The participant will recite to the psychologist the narrative they previously composed for 10-20 min. The psychologist will congratulate the participant for having succeeded in this task and advise them they are finished for the day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Initial participants will be males or females 18-65 years old who have experienced a traumatic event that meets the DSM-5 PTSD A criterion, and whose PCL-5 score is >33 (to maximize the likelihood that they will meet our psychophysiological inclusion criterion). In order to be randomized, participants must further meet this psychophysiological inclusion criterion during baseline script-driven imagery testing Although we do not require a diagnosis of PTSD, because we have set a minimum psychophysiological inclusion criterion and a valid Criterion A traumatic event, our sample will include a substantial number, likely a majority, of PTSD participants.
Key exclusion criteria (11 listed)
- Basal sitting or standing systolic blood pressure <90/60 mm Hg or basal HR <50 BPM. Those participant-candidates excluded for this reason with such readings will be counseled and referred for further clinical consultation if symptomatic or if they wish to be referred even if asymptomatic.
- Medical condition that contraindicates PPNL, e.g., congestive heart failure, heart block, insulin- requiring diabetes, chronic bronchitis, emphysema, or asthma. Asthma attacks will only be exclusionary if they: a) occurred within the past ten years, b) occurred at any time in life if induced by a β-blocker, or c) are currently being treated
- Previous adverse reaction to, or non-compliance with, a β-blocker
- Current use of medication that may involve potentially dangerous or confounding interactions with PPNL, including anti- hypertensives, antiarrhythmics, and benzodiazepines. (Possible inhibition of CYP2D6 isoenzyme-dependent reactions will not be of concern in this study, because PPNL will only be administered once a week)
- Presence of drugs of abuse, including opiates, marijuana, cocaine, amphetamines, or alcohol at the initial assessment
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 |
|---|---|---|
| Memory reactivation proceduresIn the Mismatch condition, a different, unexpected mismatch will be incorporated into the reactivation. In the Standard condition, the participant will read the narrative the same way each time. | Behavioural | Mismatch reactivation condition, Standard reactivation condition |
| PropranololPropranolol will be administered 60-min prior to each of six weekly 10-20 min. traumatic memory reactivation sessions. | Drug | Mismatch reactivation condition, Standard reactivation condition |
Primary outcome
Composite score of psychophysiological reactivity (comprising heart rate, skin conductance, and electromyography of the left corrugator muscle) using the Biopac system.
Time frame: Baseline (week 0)
psychophysiological responding during script-driven traumatic imagery compared to no imagery.
Composite score of psychophysiological reactivity (comprising heart rate, skin conductance, and electromyography of the left corrugator muscle) using the Biopac system.
Time frame: Post-treatment (week 7)
psychophysiological responding during script-driven traumatic imagery compared to no imagery.
Composite score of psychophysiological reactivity (comprising heart rate, skin conductance, and electromyography of the left corrugator muscle) using the Biopac system.
Time frame: Follow up (week 11)
psychophysiological responding during script-driven traumatic imagery compared to no imagery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. No subject identifiers will be released. The results of this study will be shared with the wider scientific community. Data will be stored in the NIMH Data Archive (NDA), where it will be available for secondary analysis. Data will be findable by the research community through the NDA Collection that will be established when this application is funded. The data will be uploaded on a rolling basis and brought current twice annually following the usual NDA data submission dates. To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. For all publications, an NDA study will be created. Each of these studies will be assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Memory reactivation procedures and Propranolol in people with Stress Disorders, Post-Traumatic, 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 1 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 6 May 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Cappellucci (857.282.1724, jcappellucci@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite score of psychophysiological reactivity (comprising heart rate, skin conductance, and electromyography of the left corrugator muscle) using the Biopac system. (time frame: Baseline (week 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.