Primary outcomeMean· 120 minutes
Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task.
| Group | Value (Milliseconds (contrast score)) | Spread |
|---|---|---|
| With Complicated Grief | 29 | 21 |
| Noncomplicated Grief Group | 18 | 18.9 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataOxytocin and Approach-avoid in Grief
NCTNCT04505904 (opens ClinicalTrials.gov in a new tab)Other idCGOT1620
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 44 participants (actual)
- Sponsor
- University of Arizona · Other
- Design
- Randomized
- Countries
1 country
United States
- Start
- 20 Mar 2015
- Primary completion
- 12 May 2017
- Completion
- 12 May 2017
- First posted
- 10 Aug 2020
- Last update posted
- 4 Mar 2025
- Conditions
- Prolonged Grief Disorder · Bereavement
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2015201620172018
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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 \[both sessions\].
Interventions
- SyntocinonDrug
- PlaceboDrug
Arms2
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.
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task.
Time frame · 120 minutes
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SyntocinonParticipants with adverse event during syntocinon condition | 0 / 39 | 0 / 39 | 2 / 39 |
| PlaceboParticipants with adverse events during placebo condition | 0 / 39 | 0 / 39 | 1 / 39 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 55 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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