Oxytocin and Approach-avoid in Grief

NCT ID: NCT04505904

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-20
• Study Completion Date: 2017-05-12

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 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].

Conditions

Prolonged Grief Disorder; Bereavement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE

Study Groups

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.

Group Type: EXPERIMENTAL

Syntocinon

Intervention Type: DRUG

Synthetic oxytocin spray, 24 IU per spray.

Placebo

Intervention Type: DRUG

Placebo spray with no active ingredient.

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.

Group Type: PLACEBO_COMPARATOR

Syntocinon

Intervention Type: DRUG

Synthetic oxytocin spray, 24 IU per spray.

Placebo

Intervention Type: DRUG

Placebo spray with no active ingredient.

Interventions

Syntocinon

Synthetic oxytocin spray, 24 IU per spray.

Intervention Type: DRUG

Placebo

Placebo spray with no active ingredient.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CGOT1620

Identifier Type: -

Identifier Source: org_study_id