Oxytocin and Approach-avoid in Grief

Bereavement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505904
• Other study ID #: CGOT1620
• Status: Completed
• Phase: N/A
• Start date: March 20, 2015
• Est. completion date: May 12, 2017

Study information

• Verified date: April 2021
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 12, 2017
• Est. primary completion date: May 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bereavement
• Prolonged Grief Disorder

Intervention

Drug:
• Syntocinon
Synthetic oxytocin spray, 24 IU per spray.
• Placebo
Placebo spray with no active ingredient.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction Time	Participant reaction time to visual stimuli in a behavioral task	120 minutes