Oxytocin and Approach-avoid in Grief

Sponsor

University of Arizona (Other)

Overall Status

Completed

CT.gov ID

NCT04505904

Collaborator

(none)

Enrollment

Location

Arms

25.8

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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].

Condition or Disease	Intervention/Treatment	Phase
Prolonged Grief Disorder Bereavement	Drug: Syntocinon Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 20, 2015

Actual Primary Completion Date :

May 12, 2017

Actual Study Completion Date :

May 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Syntocinon First 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 Synthetic oxytocin spray, 24 IU per spray. Drug: Placebo Placebo spray with no active ingredient.
Placebo Comparator: Placebo First 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 Synthetic oxytocin spray, 24 IU per spray. Drug: Placebo Placebo spray with no active ingredient.

Arm

Intervention/Treatment

Experimental: Syntocinon First

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

Synthetic oxytocin spray, 24 IU per spray.

Drug: Placebo

Placebo spray with no active ingredient.

Placebo Comparator: Placebo First

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

Synthetic oxytocin spray, 24 IU per spray.

Drug: Placebo

Placebo spray with no active ingredient.

Outcome Measures

Primary Outcome Measures

Reaction Time [120 minutes]
Participant reaction time to visual stimuli in a behavioral task

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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