Oxytocin and Approach-avoid in Grief

NCT04505904 | Completed Results

• 1 other identifier: CGOT1620
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

Oxytocin; Approach/Avoid; Older adults; Complicated Grief

Outcome Measures

Primary Outcomes (1)

• Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task.

  Participants completed the approach avoid task twice per session, with reversed instructions on the second run (i.e., "pull for yellow" became "push for yellow"). Each seven-minute run of the task consisted of 144 2500ms trials (288 trials per visit, 576 trials total across runs/sessions; 500ms inter-trial-interval). Order of instructions (i.e., "push yellow" vs. "pull yellow") was randomized and counterbalanced across participants and sessions, to address potential for order effects/habituation. Stimuli were presented via Inquisit 4 (2014), in a pseudorandomized order determined by genetic algorithm (Wager \& Nichols, 2003). Relative approach/avoidance bias was computed by subtracting median response time (RT; latency to joystick full extension) on PULL/approach trials in each stimulus category from PUSH/avoid trials in the same category (Rinck \& Becker, 2007). Positive response bias values indicate relative approach bias; negative values indicate relative avoidance bias.

  120 minutes

Study Arms (2)

Syntocinon First

EXPERIMENTAL

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; Drug: Placebo

Placebo First

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

Syntocinon DRUG

Synthetic oxytocin spray, 24 IU per spray.

Placebo First; Syntocinon First

Placebo DRUG

Placebo spray with no active ingredient.

Placebo First; Syntocinon First

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult individual experiencing death of a spouse or partner between 6 and 36 months prior to enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Prolonged Grief Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Brian Arizmendi
• Organization: University of Arizona

arizmendi@email.arizona.edu

9168473623

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 10, 2020
• Study Start: March 20, 2015
• Primary Completion: May 12, 2017
• Study Completion: May 12, 2017
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Locations

US (1)