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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Treating Adjustment Disorders Stemming From Romantic Betrayals: An Open-label Trial of Impairing Memory Reconsolidation Using Propranolol

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 6 sessions of memory reactivation under propranolol would significantly reduce trauma-related, depression, and anxiety symptom, associated with an attachment injury.

Detailed Summary:
Sponsor: Douglas Mental Health University Institute

Current Primary Outcome: Change from baseline Impact of Events Scale-Revised Scores [ Time Frame: Administered at baseline (V0), at the first treatment visit 5 weeks later (V1), at each subsequent weekly treatment visit (V2 - V6; once per week for 6 weeks), at the one-week post-treatment follow-up (V7), and at the three-month follow-up (V8). ]

Severity of Trauma and Stressor-related symptoms


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from Baseline Hopkins Symptom Checklist-25 [ Time Frame: Administered at baseline (V0), at the first treatment visit 5 weeks later (V1), at each subsequent weekly treatment visit (V2 - V6; once per week for 6 weeks), at the one-week post-treatment follow-up (V7), and at the three-month follow-up (V8). ]
    General Psychological Distress
  • Change from Baseline World Health Organization - Quality of Life BREF [ Time Frame: Administered at baseline (V0), at the first treatment visit 5 weeks later (V1), at the one-week post-treatment follow-up (V7), and at the three-month follow-up (V8). ]
    Perceived Quality of Life in 4 Domains, Psychological, Physical, Environmental, Social
  • Change from Baseline Clinical Global Impressions - Severity and Improvement [ Time Frame: Administered at baseline (V0), at the first treatment visit 5 weeks later (V1), at each subsequent weekly treatment visit (V2 - V6; once per week for 6 weeks), at the one-week post-treatment follow-up (V7), and at the three-month follow-up (V8). ]
    Clinician Administered assessment of symptom severity and improvement


Original Secondary Outcome: Same as current

Information By: Douglas Mental Health University Institute

Dates:
Date Received: April 29, 2017
Date Started: November 1, 2015
Date Completion: August 31, 2018
Last Updated: May 11, 2017
Last Verified: May 2017