Clinical trial NCT05323864: Going to Altitude With Anxious-depressive Symptoms
Official title: Going to Altitude With Anxious-depressive Symptoms - a Randomised Cross Over Trial in Individuals With Mental Disorders and Healthy Controls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia
Mental Disorder
Keywords: anxiety
depressive symptoms
high altitude
Lead sponsor: Universitaet Innsbruck
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
First posted: 2022-04-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A double-blind randomized controlled crossover trial with two groups of participants will be conducted. One group will be a group of psychiatric patients and the other group will be a group of healthy controls. The study will follow a crossover design with random allocation of condition order (i.e., normobaric hypoxia or sham hypoxia).
Primary purpose: BASIC_SCIENCE

Brief summary: Introduction: Currently, there is a lack of international guidelines or clinical recommendations for individuals with mental illnesses (i.e., bipolar disorder, posttraumatic stress disorder) going on high altitude sojourns. However, these guidelines would be important considering that mental illnesses are among the most common disorders worldwide and millions of people are hiking at high altitudes in the Alps, being granted easy access up to 3800m by cable cars. Before conceptualizing these guidelines, it seems necessary to study the physiological and psychological effects of ambient pressure changes leading to oxygen deficiency (hypoxia) in individuals with mental illnesses when being exposed to hypoxic conditions. The investigators hypothesize a shift towards negative affective responses and state anxiety as well as increased levels of neurotransmitter precursor amino acids (PHE/TYR and KYN/TRP) in individuals with mental illnesses when being exposed to hypoxic conditions.

Methods and Analysis: The investigators plan to perform a double-blind randomized controlled trial in a safe laboratory environment by using a normobaric hypoxic chamber. Participants suffering from depression and anxiety symptoms will be included as well as age and sex-matched healthy controls. They will attend a six-hour exposure equivalent to 3800m of altitude as well as a six-hour exposure to sham hypoxic conditions. Recruited participants will be screened by the Beck Anxiety and Depression Inventory, the Symptom Checklist (SCL-90) as well as an interview assessment. Affective responses in state anxiety will be assessed before, and during each hour of exposure by using the Feeling Scale (FS), Felt Arousal Scale (FAS), Positive and Negative Affect Schedule (PANAS), State-Anxiety Inventory (STAI) and subjective mental stress levels (Visual Analogue Scale; VAS). Physiological parameters will be assessed by venous blood sampling, pulse oximetry and oxidative stress level measurement before entering the chamber, after three and six hours of exposure. Additionally, symptoms of acute mountain sickness will be assessed by the Lake Louise Score before, after three and six hours of exposure. Follow-up measurements are planned one and seven days after the chamber visit, consisting of venous blood sampling, the Beck Anxiety and Depression Inventory.

A series of univariate analyses of covariance (ANCOVA) for repeated measures will be used to test the three-way (i.e. "group × condition × time") and two-way ("group × condition" and "group × time") interactions. Analyses will be adjusted for possible confounding, by adding age, sex, smoking, prior AMS, and medication status in the models as covariates.

Ethics and dissemination: Ethical approval has been obtained from the ethics committee of the Medical University of Innsbruck (1250/2021).


Eligibility criteria: Inclusion Criteria:

* sufficient command of the German language
* no psychotic or cognitive disorders
* patients suffering from anxious-depressive symptoms (meeting the cut off points of light-medium in the screening for anxiety and depression symptoms)

Exclusion Criteria:

* pregnant or breastfeeding
* permanent residence above 1000m
* overnight stays at altitudes above 2500m in the previous month
* exposure to 2500m or higher two weeks prior to the six-hour hypoxic exposure

Primary outcomes:
measure: Changes in affective responses
timeFrame: up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
measure: Changes in state anxiety
timeFrame: up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
measure: Changes in subjective perception of stress
timeFrame: up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
Secondary outcomes:
measure: Changes in anxious-depressive symptoms
timeFrame: 10 days, including 3 measurements at baseline, day 1 and follow-up day 7
measure: Changes in inflammatory parameters CRP
timeFrame: 8 days, including 4 measurements pre intervention, after 3 hours of intervention, at the end of intervention (6 hours), and at follow-up after 7 days
measure: Changes in inflammatory parameters IL-6
timeFrame: 8 days, including 4 measurements pre intervention, after 3 hours of intervention, at the end of intervention (6 hours), and at follow-up after 7 days
measure: Changes in oxidative stress
timeFrame: 6 hours, including 3 measurements, measuring pre intervention, after 3 hours of intervention, at the end of intervention (6 hours)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: University of Innsbruck, Department of Sport Science
state: Tyrol
Study officials:
References: