Oxytocin and Approach-avoid in Grief

University of Arizona

Status: Completed

Conditions: Bereavement; Prolonged Grief Disorder

Treatments: Drug: Syntocinon; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04505904

CGOT1620

Details and patient eligibility

About

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 and without 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].

Enrollment: 44 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No 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

Trial design

44 participants in 2 patient groups, including a placebo group

Syntocinon First

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Syntocinon

Placebo First

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Syntocinon