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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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Syntocinon | Drug | Synthetic oxytocin spray, 24 IU per spray. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
• Adult individual experiencing death of a spouse or partner between 6 and 36 months prior to enrollment
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85721 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | With Complicated Grief: Syntocinon First, Then Placebo | Crossover design. This arm designates the Complicated grief group, as designated to >=25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received experimental condition at visit one, and placebo at visit two 7-10 days later. Syntocinon: Synthetic oxytocin spray, 24 IU per spray. Placebo: Placebo spray with no active ingredient. |
| FG001 | With Complicated Grief: Placebo First, Then Syntocinon | Crossover design. This arm designates the Complicated grief group, as designated to >=25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received placebo condition at visit one, and syntocinon at visit two 7-10 days later. Syntocinon: Synthetic oxytocin spray, 24 IU per spray. Placebo: Placebo spray with no active ingredient. |
| FG002 | Without Complicated Grief: Syntocinon First, Then Placebo | Crossover design. This arm designates the Non-Complicated grief group, as designated to <25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received experimental condition at visit one, and placebo at visit two 7-10 days later. Syntocinon: Synthetic oxytocin spray, 24 IU per spray. Placebo: Placebo spray with no active ingredient. |
| FG003 | Without Complicated Grief: Placebo First, Then Syntocinon | Crossover design. This arm designates the Non-Complicated grief group, as designated to <25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received placebo condition at visit one, and experimental condition at visit two 7-10 days later. Syntocinon: Synthetic oxytocin spray, 24 IU per spray. Placebo: Placebo spray with no active ingredient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Milliseconds (contrast score) | 120 minutes |
6 hours per participant (two visits of three hours each). Participants were monitored for any adverse even to nasal spray during laboratory visit for data collection.
All adverse events encountered in this study are classified as "other" as they are not serious or all-cause mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Syntocinon | Participants with adverse event during syntocinon condition | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Participant discontinued functional MRI data collection due to nausea while in the scanner. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Arizmendi | University of Arizona | 9168473623 | arizmendi@email.arizona.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2021 | Oct 23, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000090382 | Prolonged Grief Disorder |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Drug | Placebo spray with no active ingredient. |
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| Physician Decision |
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| Adverse Event |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Inventory of Complicated Grief | Total score range: 0-76, with higher score meaning higher symptom severity/burden. | Mean | Standard Deviation | units on a scale |
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| Beck Depression Inventory - II | Range is 0 (absent) to 30 (highest possible symptom score, highest depression severity). Total Score is reported here. | Mean | Standard Deviation | units on a scale |
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| 39 |
| 0 |
| 39 |
| 2 |
| 39 |
| EG001 | Placebo | Participants with adverse events during placebo condition | 0 | 39 | 0 | 39 | 1 | 39 |
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| Back pain | General disorders | Systematic Assessment | Participant experienced back pain while in the MRI scanner. Participant chose to discontinue study participation due to back pain. |
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| Incidental Finding | General disorders | Systematic Assessment | There was an incidental radiologic finding requiring follow-up by participant's primary care physician. Participant discontinued. |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |