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

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ClinicalTrials.gov Identifier: NCT03151681
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Alain Brunet, Ph.D., Douglas Mental Health University Institute

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. Here, the investigators aim to extend the conditions under which reconsolidation therapy with propranolol can be used in a clinical setting. The investigators hypothesize that, compared to a wait-list control, 4-6 sessions of memory reactivation under propranolol would significantly reduce trauma-related, depression, and anxiety symptom, associated with an attachment injury.

Condition or disease Intervention/treatment Phase
Adjustment Disorders Posttraumatic Stress Disorder Trauma and Stressor Related Disorders Drug: Propranolol Pill Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Repeated measures open-label clinical trial.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Randomization to 'waitlist group' or 'treatment group' will be done by a blind investigator at the time of the statistical analyses. The randomization scheme will use the permuted-block method with a block size of four, stratified by gender (male and female) and event type (infidelity and other), and a group allocation probability of 50% (Fleiss, 1986). A sensitivity analysis will be conducted by via a cross-over method, whereby the group allocation will be reversed, and all outcome data will be re-analyzed.
Primary Purpose: Treatment
Official Title: Treating Adjustment Disorders Stemming From Romantic Betrayals: An Open-label Trial of Impairing Memory Reconsolidation Using Propranolol
Actual Study Start Date : November 1, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propranolol pill + memory reactivation Drug: Propranolol Pill
1mg/kg of propranolol 60 minutes prior to memory reactivation
Other Name: Inderal

No Intervention: Waitlist



Primary Outcome Measures :
  1. Between group difference: Wait-list vs. Treatment on Impact of Events Scale-Revised Scores [ Time Frame: Administered at baseline (Week 0), Post-Wait-list (Week 4), at each subsequent weekly visit, at the one-week post-treatment follow-up, and at the three-month follow up. ]
    Severity of Trauma and Stressor-related symptoms


Secondary Outcome Measures :
  1. Between group difference: Wait-list vs. Treatment on Hopkins Symptom Checklist-25 [ Time Frame: Administered at baseline (Week 0), Post-Wait-list (Week 4), at each subsequent weekly visit, at the one-week post-treatment follow-up, and at the three-month follow up. ]
    General Psychological Distress (Depression and Anxiety)

  2. Between group difference: Wait-list vs. Treatment on World Health Organization - Quality of Life BREF [ Time Frame: Administered at baseline (Week 0), Post-Wait-list (Week 4), at the one-week post-treatment follow-up, and at the three-month follow up. ]
    Perceived Quality of Life in 4 Domains, Psychological, Physical, Environmental, Social



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151681


Contacts
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Contact: Alain Brunet, PhD. 5147616131 ext 4348 alain.brunet@mcgill.ca

Locations
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Canada, Quebec
Douglas Mental Health University Institute Recruiting
Montréal, Quebec, Canada, H4H1R3
Contact: Alain Brunet, PhD.    5147616131 ext 4348    alain.brunet@mcgill.ca   
Contact: Michelle Lonergan, MSc.    514-761-6131 ext 3491    michelle.lonergan@mail.mcgill.ca   
Sub-Investigator: Jacques Tremblay, MD., MSc.         
Sponsors and Collaborators
Douglas Mental Health University Institute

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Responsible Party: Alain Brunet, Ph.D., Primary Investigator and Full Professor, Department of Psychiatry, McGill University., Douglas Mental Health University Institute
ClinicalTrials.gov Identifier: NCT03151681     History of Changes
Other Study ID Numbers: PRPL-006
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alain Brunet, Ph.D., Douglas Mental Health University Institute:
Reconsolidation
Propranolol
Infidelity
Attachment injury
Romantic relationships
Additional relevant MeSH terms:
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Propranolol
Disease
Stress Disorders, Post-Traumatic
Adjustment Disorders
Trauma and Stressor Related Disorders
Pathologic Processes
Stress Disorders, Traumatic
Mental Disorders
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents