Trial · NCT06364228
Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
NCT06364228, Phase 2, Recruiting, University of Nebraska
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia. Trials, record NCT06364228. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06364228
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
- NCT number
- NCT06364228
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 32 participants, estimated
- Lead sponsor
- University of Nebraska
- Conditions
- Stress
- Interventions
- Placebo, Oxytocin Intranasal Spray 12 International Unit (12IU), Oxytocin Intranasal Spray 24 International Unit (24IU), Functional MRI
- First posted
- 2024-04-15
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Chronic Stress Level in the Past Thirty Days | Baseline (Visit 1) and Post-intervention (Visit 2) | Participant's chronic ctress levels in the past thirty Days will be assessed by the Perceived Stress Scale (PSS) which asks ten questions about participant stress within the last 30 days. The questions are scored from 0 ("never") to 4 ("very often) with specific items needing to be reverse scored. Higher scores indicate higher levels of perceived stress (a worse outcome). The instrument takes about 5 minutes to complete. |
| Secondary | Participant Quality of Life | Baseline (Visit 1) and Post-intervention (Visit 2) | Participant quality of life will be assessed by the Health Organization Quality of Life- Short version (WHO-QOL-BREF) survey which measures general perceptions about quality of life in four aspects: physical health, psychological health, social relationships, and environment. The aspects are scored from 1 ('very poor') to 5 ('very good'). Aspect scores are totaled with higher scores indicating a better outcome. The instrument takes about 15 minutes to complete. |
| Secondary | Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and Empathy and Theory of Mind(EmpaToM) task | Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 60 minutes to complete at each time point. | Neural level changes will be measured by Functional Magnetic Resonance Imaging (fMRI). |
| Other | Cognitive Orientation Screening | Visit 1 (Baseline visit). It will take about 10 minutes. | Participants will complete a brief cognitive orientation screening tool, called the Mini-Mental Status Exam. This will be administered by the research assistant. If the participant scores below 26 on this measure, they will be excluded from the study, as it may indicate potential cognitive issues. The scale ranges from 0 to 30, with higher scores indicating better cognitive performance (better outcomes). |
| Other | Geriatric Anxiety Scale (GAS-10) | Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 5 minutes to complete at each time point. | Geriatric Anxiety Scale (GAS-10) will assess 10 Items. The rating scale ranges from 0 to 30 points. Higher scores indicate more severe anxiety (worse outcomes). |
| Other | Geriatric Depression Scale Short Form (GDS-SF) | Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 7 minutes to complete at each time point. | Geriatric Depression Scale Short Form (GDS-SF) is a rating scale from 0 to 15 points. Higher scores indicate more likelihood of depression symptoms and need for further assessment of depression (worse outcomes). |
| Other | Alcohol Use Disorders Identification Test | Baseline (Visit 1) and Post-intervention (Visit 2) | The Alcohol Use Disorders Identification Test (AUDIT Alcohol Screening Tool) assesses 10 items about alcohol consumption, drinking behaviors, and alcohol-related problems of the caregiver. Total scores range from 0 to 40. Higher scores indicate a greater likelihood of harmful alcohol consumption (worse outcomes). Caregivers will complete the instrument twice, each time taking about 10 minutes to finish. |
| Other | Neuropsychiatric Inventory-Questionnaire | Baseline (Visit 1) and Post-intervention (Visit 2) | The Neuropsychiatric Inventory-Questionnaire (NPI-Q) measures 12 domains. The caregiver selects present or absent for symptoms in each domain of the individual with dementia, then rates the severity of symptoms present in the past month. Each domain is scored from 0 to 3 and all domain scores are totaled. Higher scores indicating more severe symptoms (worse outcomes). This instrument also rates impact of the symptoms of individual with dementia on the caregiver (Distress) in each domain. The Distress of each domain is scored from 0 to 5 and all domain scores are totaled. Higher scores indicating more extreme levels of distress (worse outcomes). Caregivers will complete the instrument twice, each time taking about 5 minutes to finish. |
| Other | Quick Dementia Rating Scale | Baseline (Visit 1) and Post-intervention (Visit 2) | The Quick Dementia Rating Scale (QDRS) measures 10 different domains of daily functioning, mood, and behavior. Caregivers rate the severity of dementia symptoms in each domain about the individual for whom they are providing care. Total scores range from 0 to 30, with higher scores indicating more impairment (worse outcomes). Caregivers will complete the instrument twice, each time taking about 5 minutes to finish. |
| Other | The Interpersonal Reactivity Index | Baseline (Visit 1) and Post-intervention (Visit 2) | The Interpersonal Reactivity Index (IRI) is a multidimensional measure of empathy of the caregiver. This instrument has four subscales: Perspective Taking, Empathic Concern, Personal Distress, and Fantasy. Each subscale has 7 items scored from 0 to 4 with specific items needing to be reverse scored. Higher scores indicate greater empathy (better outcomes). Caregivers will complete the instrument twice, each time taking about 10 minutes to finish. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers32
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Stroop Color-Word Test | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06364228
GET https://conductscience.org/api/trials/v1/NCT06364228/papers?page=2