Oxytocin and Approach-avoid in Grief

Study Overview
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Brief Summary
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This is a completed project which was initiated prior to January 18,2017 Background: Theoretical models of complicated grief (CG) suggest that maladaptive approach (e.g., perseverative proximity-seeking of the deceased) or avoidance (e.g., excessive avoidance of reminders) behaviors interfere with a person's ability to integrate the loss and recover from their loved one's death. Due in part to conflicting evidence, little mechanistic understanding of how these behaviors develop in grief exists. We sought to (1) identify behavioral differences between CG and non-CG groups based on implicit bias for grief-, deceased-, and social-related stimuli, and (2) test the role of the neuropeptide oxytocin in shaping approach/avoidance bias. Methods: Widowed older adults with (n = 17) and without (n = 22) CG completed an approach/avoidance task measuring implicit bias for personalized, non-specific, grief-related, and other stimuli. In a double-blinded, randomized, counterbalanced design, each participant attended both an intranasal oxytocin session and a placebo session. Aims were to (1) identify differential effects of CG and stimulus type on implicit approach/avoidance bias [placebo session], and (2) investigate interactive effects of CG, stimulus type, and oxytocin vs. placebo on approach/avoidance bias [both sessions].

Official Title
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A Pull to be Close: the Differentiating Effects of Oxytocin and Grief Stimulus Type on Approach Behavior in Complicated Grief

Conditions
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Prolonged Grief Disorder, Bereavement

Intervention / Treatment
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* Drug: Syntocinon
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Adult individual experiencing death of a spouse or partner between 6 and 36 months prior to enrollment Exclusion Criteria: Inability to comprehend English; medical contraindications for other components of the study, active suicidality active homicidality active psychotic symptoms ongoing major health conditions such as cancer; uncontrolled hypertension; and medications likely to impact the oxytocin system (e.g., systemic corticosteroids). pregnant status or suspected pregnant status premenopausal status

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Syntocinon First<br>Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates those who received syntocinon at visit one and placebo at visit two. Syntocinon is 24 IU dose administered intranasally in spray form. | Drug: Syntocinon<br>* Synthetic oxytocin spray, 24 IU per spray.<br>Drug: Placebo<br>* Placebo spray with no active ingredient.<br>|
| Placebo Comparator: Placebo First<br>Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates those who received placebo at visit one, and syntocinon at visit two. | Drug: Syntocinon<br>* Synthetic oxytocin spray, 24 IU per spray.<br>Drug: Placebo<br>* Placebo spray with no active ingredient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction Time | Participant reaction time to visual stimuli in a behavioral task | 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older adults, Complicated Grief, Oxytocin, Approach/Avoid