Psychoxie: Going to Altitude With Anxious-depressive Symptoms

Sponsor

Universitaet Innsbruck (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05323864

Collaborator

Medical University Innsbruck (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hypoxia Mental Disorder	Biological: Hypoxia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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).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:

Double (Participant, Care Provider)

Primary Purpose:

Basic Science

Official Title:

Going to Altitude With Anxious-depressive Symptoms - a Randomised Cross Over Trial in Individuals With Mental Disorders and Healthy Controls

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normobaric hypoxia 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.	Biological: Hypoxia 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.
Sham Comparator: Sham hypoxia The chamber located on the campus of the University of Innsbruck's Department of Sport Science. The chamber dimension is 5 x 3m.	Biological: Hypoxia 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.

Arm

Intervention/Treatment

Experimental: Normobaric hypoxia

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.

Biological: Hypoxia

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.

Sham Comparator: Sham hypoxia

The chamber located on the campus of the University of Innsbruck's Department of Sport Science. The chamber dimension is 5 x 3m.

Biological: Hypoxia

Outcome Measures

Primary Outcome Measures

Changes in affective responses [up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention]
Self-reported questionnaire to assess affective valence, perceived activation, positive and negative affect
Changes in state anxiety [up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention]
Self-reported questionnaires to assess state anxiety
Changes in subjective perception of stress [up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention]
Self-reported questionnaires to assess subjective perception of stress

Secondary Outcome Measures

Changes in anxious-depressive symptoms [10 days, including 3 measurements at baseline, day 1 and follow-up day 7]
Self-reported questionnaires to assess depression symptoms, anxiety symptoms, and subjectively perceived impairment due to physical and psychological symptoms
Changes in inflammatory parameters CRP [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]
Venous blood samples to assess CRP (C-reactive protein)
Changes in inflammatory parameters IL-6 [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]
Venous blood samples to assess IL-6 (interleukin 6)
Changes in oxidative stress [6 hours, including 3 measurements, measuring pre intervention, after 3 hours of intervention, at the end of intervention (6 hours)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)