Comparing two methods to reduce stress responses during traumatic memory recall

Mismatch vs. Standard Intervention During Memory Reconsolidation Blockade With Propranolol: Effect on Psychophysiological Reactivity During Traumatic Imagery

This study is testing a new way to help people who have gone through trauma feel less stressed when they remember their experiences by using a special treatment alongside standard care.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Charlestown, Massachusetts)
• Trial ID: NCT05853627 on ClinicalTrials.gov

What this trial studies

This project aims to evaluate the effectiveness of a novel intervention that combines memory reactivation with the beta-blocker propranolol to reduce physiological responses to traumatic memories. Participants who have experienced a traumatic event will be randomized into two groups: one receiving standard treatment and the other receiving a treatment that includes a 'mismatch' component designed to enhance memory deconsolidation. The study will measure participants' heart rate, skin conductance, and muscle responses during guided imagery of their traumatic experiences to assess the impact of the interventions. The goal is to determine if the mismatch approach leads to greater reductions in stress reactivity compared to standard methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 who have experienced a traumatic event and exhibit significant post-traumatic stress symptoms.

Not a fit: Patients with low baseline heart rates or blood pressure may not benefit from this study due to exclusion criteria.

Why it matters

Potential benefit: If successful, this intervention could provide a more effective treatment for individuals suffering from post-traumatic stress symptoms.

How similar studies have performed: Previous studies using propranolol for memory reconsolidation have shown promising results, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

1. 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.
2. 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
3. Previous adverse reaction to, or non-compliance with, a β-blocker
4. 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)
5. Presence of drugs of abuse, including opiates, marijuana, cocaine, amphetamines, or alcohol at the initial assessment
6. Pregnancy or breast feeding. Women of childbearing potential will have a pregnancy test at the initial assessment
7. Presence of a contraindicating psychiatric condition, e.g., psychotic, bipolar, melancholic, or active substance use disorder; or suicidality (see below)
8. 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
9. 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
10. Inability to understand the study's procedures, risks, and side effects, or to otherwise give informed consent for participation
11. Participant candidate does not understand English. This exclusion criterion is necessary because the procedures require a nuanced dialogue with English-speaking investigators.

Where this trial is running

Charlestown, Massachusetts

• Massachusetts General Hospital Home Base Program — Charlestown, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: James Cappellucci

Conditions Stress Disorders, Post-Traumatic