The Trauma of Betrayal: Treating Adjustment Disorder With Reconsolidation Blockade Under Propranolol

NCT ID: NCT03151681

Last Updated: 2022-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2022-06-06

Brief Summary

Attachment injuries are events occurring within couple relationships that involve betrayal or abandonment by a significant other during times of need (e.g., infidelity). They can be understood as relationship traumas, which can lead to debilitating symptoms consistent with posttraumatic stress disorder (PTSD), depression, and generalized anxiety for the injured partner. Research has demonstrated that the presence of an attachment injury represents a barrier to empirically effective couple's therapy. However, disrupting memory reconsolidation with the beta-blocker propranolol has been shown to alleviate PTSD symptoms by attenuating the salience of the emotional trauma memory, representing an interesting avenue for the treatment of adjustment disorders stemming from attachment injuries. Moreover, evidence suggests that a certain degree of mismatch, or an error between what is expected/predicted to occur and what actually occurs, must be present in order for a memory to destabilize and enter the reconsolidation phase following retrieval. Here, the investigators aim to extend the conditions under which reconsolidation therapy with propranolol can be used in a clinical setting, as well as assess whether incorporating mismatch enhances treatment effects. The investigators hypothesize that, compared to a wait-list control, 4-6 sessions of memory reactivation under propranolol will significantly reduce trauma-related and general anxio-depressive symptoms, associated with an attachment injury. Moreover, the investigators hypothesize that participants randomized to the mismatch group will improve significantly more than the standard treatment group on all variables of interest.

Conditions

Adjustment Disorders; Posttraumatic Stress Disorder; Trauma and Stressor Related Disorders

Keywords

Reconsolidation; Propranolol; Infidelity; Attachment injury; Romantic relationships

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Propranolol pill + mismatch memory reactivation

Prediction-error will be incorporated into each treatment sessions.

Group Type: EXPERIMENTAL

Propranolol Pill

Intervention Type: DRUG

1mg/kg of propranolol 60 minutes prior to memory reactivation

Propranolol pill + standard memory reactivation

Group Type: EXPERIMENTAL

Propranolol Pill

Intervention Type: DRUG

1mg/kg of propranolol 60 minutes prior to memory reactivation

Waitlist

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Propranolol Pill

1mg/kg of propranolol 60 minutes prior to memory reactivation

Intervention Type: DRUG

Other Intervention Names

Inderal

Eligibility Criteria

Inclusion Criteria

• Diagnosis of an adjustment disorder or chronic adjustment disorder, as defined by the Diagnostic and Statistical Manual for Mental Disorders, as a result of an attachment injury, defined as an event involving the perceived betrayal, violation of trust, or abandonment by a significant other.
• Currently experiencing clinically important psychological distress as a result of the event, as defined by a score of at least 22 on the IES-R, and a score of at least "moderately ill" on the Clinical Global Impressions - Severity of Illness Scale.
• Must have been in the romantic relationship for at least 6 months prior to the event.
• Must not take psychotropic medication.
• Fluency in English or French

Exclusion Criteria

• Systolic blood pressure <100 mm Hg;
• Cardiac rhythm below 55 beats per minute;
• A medical condition that contraindicates the administration of propranolol, e.g., Asthma, chronic obstructive pulmonary disease, cardiac insufficiency, cardiac choc, Second- or third-degree atrioventricular block, diabetes, spastic angina, auricular sinus illness, bradycardia, Raynaud's disease, severe peripheral vascular disease, untreated Pheochromocytoma, arterial hypotension, previous anaphylactic allergic shock;
• Previous adverse reaction to, or non-compliance with, beta-blocker;
• Current use of a substance that may involve potentially dangerous interactions with propranolol, including P450 2D6 inhibitors.
• Women who are pregnant or breast feeding;
• Individuals currently participating in any other form of psychotherapy (other than strictly supportive).
• History of substance dependence disorder, bipolar disorder, or psychotic disorder;
• Participants judged (based on history, mental status exam, clinical impression, or the Suicidal Behaviors Questionnaire as being at significant risk of suicidal behavior.
• Participation in another drug trial within 30 days prior to the screening visit
• Presence of any clinical condition that might interfere with the interpretation of the efficacy and safety results.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Douglas Mental Health University Institute

OTHER

Sponsor Role: lead

Responsible Party

Alain Brunet, Ph.D.

Primary Investigator and Full Professor, Department of Psychiatry, McGill University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Douglas Mental Health University Institute

Montreal, Quebec, Canada

Countries

Canada

References

Lonergan M, Saumier D, Pigeon S, Etienne PE, Brunet A. Treatment of adjustment disorder stemming from romantic betrayal using memory reactivation under propranolol: A open-label interrupted time series trial. J Affect Disord. 2022 Nov 15;317:98-106. doi: 10.1016/j.jad.2022.08.082. Epub 2022 Aug 27.

Reference Type: RESULT

PMID: 36031005 (View on PubMed)

Other Identifiers

PRPL-006

Identifier Type: -

Identifier Source: org_study_id