Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
ConditionStress
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age50+
SponsorUniversity of Nebraska
About this trial
More than 15 million family caregivers provide support for individuals with Alzheimer's disease (AD) or related dementias. This number is expected to grow with the increasing population of persons with dementia (PWD). Stress in caregivers to older adults with chronic diseases is already a significant public health issue because it is associated with multiple negative physical and mental health outcomes for the caregiver (e.g., depression, cardiovascular disease) and can negatively impact the health of the PWD as well. Importantly, stress levels are even higher in female than male caregivers and in caregivers to PWD than other chronic conditions that affect older adults.
There are numerous interventions to improve well-being in caregivers to PWD, but only two have been shown to moderately improve caregiver depression and quality of life in the PWD. However, both of the interventions are time and energy intensive. One promising candidate to reduce stress and improve quality of life is the endogenous neuropeptide oxytocin (OXT). Intranasal OXT interventions have been shown to successfully reduce stress and increase quality of life in other populations, including patients with borderline personality disorder, Post-traumatic Stress Disorder (PTSD), Anxiety Disorder, and Depressive Disorder. This study will assess the efficacy and safety of intranasal oxytocin (OXT) to improve the quality of life and reduce chronic stress levels in the caregivers to PWD. Participants will be randomly enrolled to one of three groups: 12 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo. The study drug will be administered daily for 21 days.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Females 50 years of age or older
Currently an unpaid family caregiver to an older adult (50 years and older) with dementia for at least five hours a week for at least six months
Normal or corrected to normal vision and hearing
Mobility to travel to University of Nebraska Medical Center (UNMC) for study procedures including brain imaging
Disqualifiers
Major medical illness that contraindicates oxytocin (OXT) administration (e.g., severe liver disease, seizure disorder, metabolic disorder)
History of allergic reaction to oxytocin (OXT) and its nasal spray product
History of central nervous system (CNS) disease, including history of seizure, epilepsy, CNS tumor, CNS hemorrhage, or serious CNS infection including meningitis or encephalitis
Currently pregnant or planning to become pregnant during the course of the study
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
DrugPlacebo intranasal spray liquid with no oxytocin will be delivered in 2 puffs to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).
Oxytocin Intranasal Spray 12 International Unit (12IU)
DrugParticipants weighing less than 40 kg (88 pounds) will receive 12 IU of oxytocin delivered as 1 puff (6 IU) to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).
Oxytocin Intranasal Spray 24 International Unit (24IU)
DrugParticipants weighing more than 40 kg (880 pounds) will receive 24 IU of oxytocin delivered as 2 puffs (12 IU) to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).
Functional MRI
Procedure/SurgeryFunctional MRI (fMRI) scan with affective Stroop and Empathy and Theory of Mind task (EmpaTom task will administered pre- and post-administration of oxytocin.
Treatment groups
32 Participants
are divided into 3 treatment groupsGroup A: Intranasal Spray PlaceboPlacebo comparator 2 interventions
Group B: Oxytocin Intranasal Spray 12 International UnitsActive comparator 2 interventions
Group C: Oxytocin Intranasal Spray 24 International UnitsActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Chronic Stress Level in the Past Thirty Days
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.
Time frame
Baseline (Visit 1) and Post-intervention (Visit 2)Secondary outcomes
1
Participant Quality of Life
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.
Time frame
Baseline (Visit 1) and Post-intervention (Visit 2)2
Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and Empathy and Theory of Mind(EmpaToM) task
Neural level changes will be measured by Functional Magnetic Resonance Imaging (fMRI).
Time frame
Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 60 minutes to complete at each time point.Other outcomes
1
Cognitive Orientation Screening
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).
Time frame
Visit 1 (Baseline visit). It will take about 10 minutes.2
Geriatric Anxiety Scale (GAS-10)
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).
Time frame
Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 5 minutes to complete at each time point.3
Geriatric Depression Scale Short Form (GDS-SF)
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).
Time frame
Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 7 minutes to complete at each time point.4
Alcohol Use Disorders Identification Test
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.
Time frame
Baseline (Visit 1) and Post-intervention (Visit 2)Sponsors and contacts
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Source ClinicalTrials.gov