Going to Altitude With Anxious-depressive Symptoms (Psychoxie)
Primary Purpose
Hypoxia, Mental Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Hypoxia
Sponsored by
About this trial
This is an interventional basic science trial for Hypoxia focused on measuring anxiety, depressive symptoms, high altitude
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
Sites / Locations
- University of Innsbruck, Department of Sport ScienceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Normobaric hypoxia
Sham hypoxia
Arm Description
Normobaric hypoxia equivalent to 3800m terrestrial altitude. The chamber located on the campus of the University of Innsbruck's Department of Sport Science. The chamber dimension is 5 x 3m.
The chamber located on the campus of the University of Innsbruck's Department of Sport Science. The chamber dimension is 5 x 3m.
Outcomes
Primary Outcome Measures
Changes in affective responses
Self-reported questionnaire to assess affective valence, perceived activation, positive and negative affect
Changes in state anxiety
Self-reported questionnaires to assess state anxiety
Changes in subjective perception of stress
Self-reported questionnaires to assess subjective perception of stress
Secondary Outcome Measures
Changes in anxious-depressive symptoms
Self-reported questionnaires to assess depression symptoms, anxiety symptoms, and subjectively perceived impairment due to physical and psychological symptoms
Changes in inflammatory parameters CRP
Venous blood samples to assess CRP (C-reactive protein)
Changes in inflammatory parameters IL-6
Venous blood samples to assess IL-6 (interleukin 6)
Changes in oxidative stress
Capillary blood samples from the fingertip collected with the Free Carpe Diem device by DIACRON International to measure total antioxidant capacity and the antioxidant potential of plasma
Full Information
NCT ID
NCT05323864
First Posted
February 21, 2022
Last Updated
May 4, 2023
Sponsor
Universitaet Innsbruck
Collaborators
Medical University Innsbruck
1. Study Identification
Unique Protocol Identification Number
NCT05323864
Brief Title
Going to Altitude With Anxious-depressive Symptoms
Acronym
Psychoxie
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaet Innsbruck
Collaborators
Medical University Innsbruck
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Mental Disorder
Keywords
anxiety, depressive symptoms, high altitude
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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).
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normobaric hypoxia
Arm Type
Experimental
Arm Description
Normobaric hypoxia equivalent to 3800m terrestrial altitude. The chamber located on the campus of the University of Innsbruck's Department of Sport Science. The chamber dimension is 5 x 3m.
Arm Title
Sham hypoxia
Arm Type
Sham Comparator
Arm Description
The chamber located on the campus of the University of Innsbruck's Department of Sport Science. The chamber dimension is 5 x 3m.
Intervention Type
Biological
Intervention Name(s)
Hypoxia
Intervention Description
Participants will be randomly assigned to start with the normobaric hypoxia condition or the sham hypoxia condition. They will swap to the other condition during the second visit, which will be executed at least 14 days after the first visit. Each sojourn will last for six hours and participants will reside in the chamber individually. During the six-hour stay, participants will be allowed to move freely within the chamber.
Primary Outcome Measure Information:
Title
Changes in affective responses
Description
Self-reported questionnaire to assess affective valence, perceived activation, positive and negative affect
Time Frame
up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
Title
Changes in state anxiety
Description
Self-reported questionnaires to assess state anxiety
Time Frame
up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
Title
Changes in subjective perception of stress
Description
Self-reported questionnaires to assess subjective perception of stress
Time Frame
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 Outcome Measure Information:
Title
Changes in anxious-depressive symptoms
Description
Self-reported questionnaires to assess depression symptoms, anxiety symptoms, and subjectively perceived impairment due to physical and psychological symptoms
Time Frame
10 days, including 3 measurements at baseline, day 1 and follow-up day 7
Title
Changes in inflammatory parameters CRP
Description
Venous blood samples to assess CRP (C-reactive protein)
Time Frame
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
Title
Changes in inflammatory parameters IL-6
Description
Venous blood samples to assess IL-6 (interleukin 6)
Time Frame
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
Title
Changes in oxidative stress
Description
Capillary blood samples from the fingertip collected with the Free Carpe Diem device by DIACRON International to measure total antioxidant capacity and the antioxidant potential of plasma
Time Frame
6 hours, including 3 measurements, measuring pre intervention, after 3 hours of intervention, at the end of intervention (6 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Innsbruck, Department of Sport Science
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Rausch, PhD
Phone
+4351250745851
Email
linda.rausch@uibk.ac.at
12. IPD Sharing Statement
Learn more about this trial
Going to Altitude With Anxious-depressive Symptoms
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