Bereavement, Prolonged Grief Disorder
Conditions
Keywords
Oxytocin, Approach/Avoid, Older adults, Complicated Grief
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 \[both sessions\].
Interventions
DRUGSyntocinon
Synthetic oxytocin spray, 24 IU per spray.
DRUGPlacebo
Placebo spray with no active ingredient.
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task. | 120 minutes | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Complicated Grief Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates the Complicated grief group, as designated to \>25 cutoff score on standardized measure (the Inventory of Complicated Grief). All participants in this group received both synthetic oxytocin and placebo
Syntocinon: Synthetic oxytocin spray, 24 IU per spray.
Placebo: Placebo spray with no active ingredient. | 17 |
| Noncomplicated Grief Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates the noncomplicated grief group, as divided based on cutoff score on standardized measure (the Inventory of Complicated Grief)
Syntocinon: Synthetic oxytocin spray, 24 IU per spray.
Placebo: Placebo spray with no active ingredient. | 22 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Complicated Grief | Noncomplicated Grief | Total |
|---|---|---|---|
| Age, Continuous | 68.96 years STANDARD_DEVIATION 6.68 | 69.83 years STANDARD_DEVIATION 6.68 | 69.45 years STANDARD_DEVIATION 6.68 |
| Beck Depression Inventory - II | 16.41 units on a scale STANDARD_DEVIATION 6.7 | 6 units on a scale STANDARD_DEVIATION 4.86 | 10.4 units on a scale STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 22 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Inventory of Complicated Grief | 35.18 units on a scale STANDARD_DEVIATION 7.9 | 14.47 units on a scale STANDARD_DEVIATION 6.36 | 23.5 units on a scale STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 22 Participants | 38 Participants |
| Region of Enrollment United States | 17 participants | 22 participants | 39 participants |
| Sex: Female, Male Female | 9 Participants | 19 Participants | 28 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 2 / 39 | 1 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
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.
Time frame: 120 minutes
Population: Of note, for analysis purposes, we collapsed across crossover groups to yield two groups, complicated grief and non-complicated grief. This is consistent with reporting methods of other relevant literature in this area and allows for direct conceptual comparison to these previous studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| With Complicated Grief | Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task. | Syntocinon First | 29 Milliseconds (contrast score) | Standard Deviation 21 |
| With Complicated Grief | Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task. | Placebo First | 7.5 Milliseconds (contrast score) | Standard Deviation 21 |
| Noncomplicated Grief Group | Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task. | Syntocinon First | 18 Milliseconds (contrast score) | Standard Deviation 18.9 |
| Noncomplicated Grief Group | Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task. | Placebo First | 13.0 Milliseconds (contrast score) | Standard Deviation 11.5 |